Chlorhexidine Digluconate Gel Research Articles

Comparison of the effectiveness of Morus alba and chlorhexidine gels as an adjunct to scaling and root planing on stage II periodontitis - A randomized controlled clinical trial.

The present study aimed to assess and compare the effect of Morus alba and chlorhexidine gel as an adjunct to scaling and root planing (SRP) in treating stage II periodontitis. A single-blind, randomized controlled trial was conducted on 180 patients with stage II periodontitis who received full-mouth SRP. They were randomly assigned to receive chlorhexidine digluconate (CHX) gel, Morus alba (MA) and placebo gel for Groups A, B and C, respectively, at the baseline, 15 days and 30 days. Plaque index (PI), Gingival index (GI), periodontal pocket depth (PPD) and quantitative analysis (culture) of Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis and Tannerella forsythia were assessed at baseline and 45 days. Analysis of variance was used to compare the significant difference in PI, GI, PPD and microbiological parameters between the three groups after the intervention, followed by post hoc Mann-Whitney U and Tukey's HSD test for clinical and microbiological parameters, respectively. Intergroup comparison of the PI, GI and microbiological parameters between the MA and CHX groups at the end of 45 days did not show a statistically significant difference (p > 0.05), whereas a statistically significant difference was observed for PPD between MA and CHX groups with the mean difference of 0.18 mm (p = 0.002). Morus alba gel was found to be effective in decreasing PPD. However, there was no difference between Morus alba and chlorhexidine gel as an adjunct to SRP in treating stage II periodontitis.

Corneal Blindness Caused by Accidental Ocular Use of Chlorhexidine (Hexz) Gel in Two Newborn Born in the Health District of Kati in Mali

Introduction: Corneal opacities in children are relatively common. In children, it is urgent because of the risk of irreversible amblyopia. The causes of these blindnesses vary considerably according to the regions of the world. Chlorhexidine digluconate is a broad-spectrum antiseptic directed against gram-positive and gram-negative bacteria. It has been used as an antiseptic for more than 50 years, both in humans and in animals. However, despite these benefits, it can cause serious damage if applied to the eyes. Incidents of eye damage with 7.1% chlorhexidine have been reported to WHO across Africa. Observation: We report and write two cases of bilateral corneal blindness caused by accidental ocular use of chlorhexidine (HEXZ) GEL 7.1% in two newborns in the health district of Kati in MALI. The ophthalmological examination had revealed corneal opacity, conjunctival hyperaemia and limbic ischemia greater than 50% in 1 eye out of 4, corresponding to stage IV of the ROPPER HALL classification; 2 eyes out of 4 were at stage III and 1 eye out of 4 was at stage I of the same classification. Conclusion: It is essential to ensure correct use of chlorhexidine digluconate gel 7%. It is an antiseptic which should not be used on the ocular and auditory mucous membranes, at the risk of most often permanent burns.

Effect of Heated Irrigating Solutions on the Cyclic Fatigue Resistance of Reciprocating Endodontic Files

Objectives: The aim of this study was to evaluate the effect of heated irrigating solutions on the cyclic fatigue resistance of reciprocating endodontic files. Materials and Methods: Reciproc Blue, ProDesign S and X1-Blue files were immersed in the irrigating solutions 5.25% NaClO and 2% chlorhexidine digluconate gel heated in oven at 37ºC for 10 min. In same conditions, saline solution was considered as control. The following groups (n=15) were considered: RSs (Reciproc Blue + saline solution); RNa (Reciproc Blue + 5.25% NaClO); RCd (Reciproc Blue + 2% Chlorhexidine digluconate gel); PSs (ProDesign S + saline solution); PNa (ProDesign S + 5.25% NaClO); PCd (ProDesign S + 2% Chlorhexidine digluconate gel; XSs (X1-Blue + Saline solution); XNa (X1-Blue + 5.25% NaClO) and XCd (X1 Blue + 2% Chlorhexidine digluconate gel). Cyclic fatigue test was performed in a device with a 60 degrees curved canal and 5 mm radius immersed in water at 37ºC. The time for file failure was recorded in seconds to calculate the number of cycles to fracture (NCF). Data were submitted to ANOVA followed by Tukey's test (α=0.05%) comparing split plots (SPSS 26.0). Results: There was no statistically significant difference for NCF between irrigating solutions and control in all file types. ProDesign S showed greater and significant difference when compared to Reciproc Blue and X1 Blue in all irrigating solutions and control. Conclusions: NCF value in each file type was not influenced by the solutions. Among file types, the NCF value was higher for ProDesign S and lower for X1-Blue in all solutions. Clinical Relevance: Heated irrigating solutions is not a relevant factor in relation to fracture resistance of reciprocating endodontic files; however, the fracture was influenced by the file types.

Prevalent cord-stump care practices among mothers of infants: Against the backdrop of chlorhexidine digluconate gel scale-up

Within the context of Chlorhexidine scale-up, this cross-sectional study explores umbilical cord-stump care practices of mothers of infants in Enugu-North, and their perspectives on specific issues fueling unhygienic cord-stump care practices. Quantitative data were collected from 397 participants using a structured questionnaire. Cumulatively, 29.2% of the respondents resorted to unhygienic substances for cord-stump-care, and 11.3% of them used Chlorhexidine for care. Compared to mothers within the ‘22-26-year-old’ category, mothers within the ‘17-21-year-old’ category were more likely to desire a short time-to-cord-separation (OR = 2.1; 95% CI = 1.0–4.5). First-time mothers (OR = 5.9; 95% CI = 3.5–10.2) and younger mothers (OR = 152.8; 95% CI = 36.2–891.1) were more likely to yield to gatekeepers' opinions on newborn-care compared to non-first-time mothers and older mothers (32-40-year-old category), respectively. This study identifies putative predictors of newborn-care decisions within the context of Chlorhexidine scale-up. Further, the prevalence of Chlorhexidine use was low, and the use of unhygienic substances was significant.

COMPARATIVE EVALUATION OF THE EFFICACY OF 4% MANGOSTEEN GEL AND 1% CHLORHEXIDINE DIGLUCONATE GEL IN MANAGEMENT OF PATIENTS WITH CHRONIC GINGIVITIS: A RANDOMIZED CLINICAL TRIAL

To clinically evaluate & compare the efficacy of 4% Mangosteen Gel and 1% chlorhexidine digluconate gel in managing patients with chronic gingivitis. Materials and Methods: A total of 50 patients with an age group of 20-45 years diagnosed with generalized plaque-induced gingivitis were selected for this clinical trial once attaining their informed consent. A thorough case history was chronicled comprising plaque index (P.I.), gingival index (G.I.) and Sulcus bleeding index (SBI) at baseline; then full-mouth scaling and polishing (SAP) was performed by a solitary attuned examiner. Patients were then randomly assigned into two groups using a computer-generated random numbering sequence system. Patients in group A received 4% Mangosteen Gel, and group B received 1% chlorhexidine digluconate gel for home application. The post-treatment follow-up examination for P.I., G.I. and SBI changes were assessed after 14 days and 21 days and compared with baseline data. Results: In both the groups, the mean plaque index, gingival index and sulcus bleeding index scores were significantly decreased after the 14th and 21st day compared to baseline scores. There was no significant difference between the groups, but only in group B, there was a substantial difference in SBI scores observed on day 21. Conclusion: 4% Mangosteen Gel and 1% chlorhexidine digluconate gel were clinically effective when used as an adjunct to SAP in managing patients with gingivitis. Hence, 4% Mangosteen Gel can be considered an alternative to 1% chlorhexidine digluconate gel without any side effects in managing generalized plaque-induced gingivitis.

The comparison of the efficacy of Alveogyl, 0.8% Hyaluronic acid, and 0.2% Chlorhexidine Digluconate in alveolar osteitis

Aim: The aim of this study was to compare the efficacy of Alveogyl, 0.8% hyaluronic acid (HA), and 0.2% chlorhexidine digluconate (CHX) gel in reducing pain and improving clinical signs and symptoms of alveolar osteitis.
 Methodology: The clinical data of patients treated for alveolar osteitis between 01/01/2015 and 01/01/2019 were retrieved for this study. All patients were initially treated by curettage and physiological saline irrigation. Patients were then divided into 4 groups. Group 1 was considered the control group; no other biomaterials were administered after curettage and physiological saline irrigation. All other groups were administered an additional treatment in the socket after curettage and physiological saline irrigation (Group 1 – Alveogyl; Group 2 - 0.8% HA; Group 3 - 0.2% CHX). Patents were evaluated before surgery as well as days 3 and 7 after surgery. The postoperative evaluations included: Visual analog scale(VAS) pain scores, the presence of clinical signs and symptoms of exposed alveolar bone, disorganized blood clot, inflammation around the socket, and bad odor and taste.
 Results: Sixty-seven patients were included in the study. There was no statistically significant difference between groups in all control evaluations (p>0.05). There was significantly reduced inflammation around the extraction socket on postoperative day 7 in the CHX group compared to that in the control group (p<0.05). No other significant changes in clinical signs and symptoms were observed among groups.
 Conclusion: There was no significant difference between curettage with physiological saline irrigation alone and the addition of Alveogyl, 0.8% HA, or 0.2% CHX in the reduction of pain in alveolar osteitis. Nonetheless, CHX may reduce inflammation around the extraction sockets.
 
 How to cite this article: Dereci Ö, Görkem T, Koşar YÇ. The comparison of the efficacy of Alveogyl, 0.8% Hyaluronic acid, and 0.2% Chlorhexidine Digluconate in alveolar osteitis. Int Dent Res 2021;11(1):6-11.
 https://doi.org/10.5577/intdentres.2021.vol11.no1.2
 
 Linguistic Revision: The English in this manuscript has been checked by at least two professional editors, both native speakers of English.

Influence of sodium hypochlorite and chlorexidine on the dynamic cyclic fatigue resistance of XP-Endo Finisher instruments

Aim: This study evaluated the cyclic fatigue resistance of XP-Endo Finisher (XPF), associated with two different irrigation solutions: sodium hypochlorite 6% (NaOCl) or chlorhexidine digluconate gel 2% (CHX) in a dynamic model. The null hypothesis tested was that there was no statistically significant difference. Methodology: 30 new files were divided into three groups (n=10) based on the irrigation solution used. Group 1: XPF using CHX as an irrigation solution; Group 2: XPF using NaOCl as an irrigation solution; Group 3 (control group): XPF using lubricating oil (LO). The artificial canal was manufactured measuring 1.5 mm wide, 20 mm long, and 3.5 mm deep with a straight cervical segment measuring 14.29 mm. A curved apical segment 4.71 mm with 3 mm radius and 90° of curvature and an ending with straight apical portion measuring 1 mm long. Resistance to cyclic fatigue was determined by recording time to fracture, and the file surface was examined under scanning electron microscopy. Results: Data were tabulated and subjected to statistical analysis of variance. Student-Newman-Keuls test for multiple comparisons, with a significance level of 5%. The average time took for file fracture was 306.7 seconds for 2% chlorhexidine and 67,6 for 6% sodium hypochlorite. 2% CHX was significantly different from the NaOCl and LO groups (P< .001). Conclusions: XPF presented the best results of fracture time and the number of cycles to fracture when used along with 2% chlorhexidine in canals with severe apical curvature, and there was no statistical difference in fragment size.

Differential effectiveness of calcium hydroxide with 2% chlorhexidine digluconate and 25% propolis as a root canal medicament against Enterococcus faecalis (In vitro)

Background: One of the most common microorganisms found in infected teeth after root canal treatment is Enterococcus faecalis (E. faecalis). This bacteria can cause failure in root canal treatment, so it is necessary to provide intracanal medicament, such as calcium hydroxide, which can increase antibacterial effectiveness by adding a mixing agent. One of the calcium hydroxide mixing ingredients is chlorhexidine (CHX) digluconate gel 2%, which can increase the activity of hydroxyl ions in calcium hydroxide. A natural mixing ingredient is 25% propolis, which contains flavonoids with an antibacterial effect. Objective: The aim is to determine the difference in antibacterial effectiveness between a combination of calcium hydroxide with 2% CHX digluconate or 25% propolis as an intracanal medicament against E. faecalis (in vitro) bacteria. Methods: This research used an experimental in vitro laboratory test with 18 teeth that had a single root canal. Teeth were sterilized, had root canal treatment, and cut off at the crown. Antibacterial efficacy was calculated by measuring optical density (OD) values with spectrophotometry. The data were analyzed using the Kruskal–Wallis test followed by the Mann–Whitney test. Results: The largest OD difference group was in the calcium hydroxide mixture 25% propolis than calcium hydroxide mixture 2% CHX gel. Conclusion: There was a difference in the antibacterial power of the intracanal medicament, calcium hydroxide combination with 2% CHX digluconate gel or 25% propolis. The combination of calcium hydroxide with propolis 25% more effective than the mixture of calcium hydroxide with 2% CHX digluconate as root canal medicament against E. faecalis bacteria.

Survival rate of pulpectomy in primary teeth using Feapex® paste: a clinical study in infants

Objective: The aim of this clinical study was to evaluate the survival rate of a new pulpectomy protocol using2% chlorhexidine digluconate gel and Feapex paste for endodontic treatment in primary teeth. Material andMethods: A total of 105 pulpectomies were performed in anterior and posterior teeth of 48 infants (1-3 yearsold) with high caries experience with irreversible pulpitis or pulp necrosis. All treatments were performed bydental surgeons with no specialization in Pediatric Dentistry, under local anesthesia and rubberdam isolation.Manual files were used in conjunction with 2% chlorherixidine gel for root canal instrumentation, and Feapex®paste was used as a obturation material. The clinical and radiographic outcomes were collected by one trainedindependent evaluator with a follow-up period of 24months. Success was determined by the absence of pain,pathological mobility, pathologic bone rarefaction, pathological root resorption and soft tissue pathology aroundthe affected tooth Survival of the endodontic treatment was evaluated by estimating survival rates throughKaplan-Meier curves. Cox Regression analysis with shared fragility were performed to evaluate the associationbetween the independent variables to endodontic treatment failure (alpha=5%). Results: After 24 months, thetreatment survival was 86% (SE=0.03). Root resorption at baseline was associated with a higher risk of failure(HR=2.81; CI=1.12-7.08; p=0.027). The survival rate of the endodontic treated teeth due to dental traumawas 100%, while teeth with dental caries had lower survival rate (85.05%; p&lt;0.001*). Other variables analyzedincluded gender, age of the child, tooth position (incisor/molar), restoration type, obturation quality, andcaries experience were not associated with treatment failure (p&gt;0.05). Conclusion: The new protocol using2% chlorhexidine digluconate and Feapex® presented a high survival rate and can be considered as a suitableprotocol for pulpectomy in primary teeth.Trial Registration: REBEC (RBR-282s2f).KEYWORDSRoot canal treatment; Primary teeth; Infants; Pulpectomy.

Assessment of the Use Of Chlorhexidine Digluconate Gel for Cord Care at Kangundo Level 4 Hospital

Assessment of the Use Of Chlorhexidine Digluconate Gel for Cord Care at Kangundo Level 4 Hospital

Assessment of the use of chlorhexidine digluconate gel for cord care at Kangundo Level 4 Hospital

Background: Sepsis continues to be an important cause of morbidity and mortality in neonates. One of the most important portals of entry for infections is the umbilical cord. Proper care of the cord can prevent many of these cases of sepsis and hence reduce neonatal mortality rates. In Kenya, the use of chlorhexidine digluconate (CHX) gel was introduced to scale in 2016 and received with mixed reactions in some hospitals with reports of medication errors and ineffectiveness being received. This study sought to find out the knowledge, practices and attitude on its use in Kangundo Level 4 hospital. Methods and materials: The study was carried out at Kangundo level 4 hospital between June and August 2019. It was a descriptive cross-sectional study with both quantitative and qualitative components. A questionnaire was used for the quantitative data collection while focus group discussions were held for the qualitative data collection. Ethical approval was sought prior to commencement of data collection. Results: A total of 19 clients and 24 healthcare workers were interviewed and two focus group discussions held. All the 19 clients had delivered in the hospital and only three were first-time mothers. Education on how to use chlorhexidine (CHX) was given to 16/19 (84%) of the clients interviewed. Duration of application varied among clients; 4 days 5/19 (26%), 7 days, 12/19 (64%) and until the stump falls off, 2/19 (10%). Twenty of the 24 HCWs (83%) interviewed advised the patients on cleaning the cord prior to application of CHX, frequency of application varied from OD 15/24 (62%), BD 3/24 (13%) and TID 6/24 (25%). Two FGDs were held for HCW; lack of training and clear instructions on how to use the gel as major contributors to ineffectiveness of CHX. Conclusion: There was poor understanding on the use of CHX among both clients and HCWs at Kangundo level 4 hospital. Cleaning of the stump prior to gel application is important to prevent accumulation of the dry gel and allow contact with the wound. There is need for training and development of a standard operating procedure on use of CHX.

Hypersensitivity reaction of the gingiva to chlorhexidine: case report and literature review

The aim of this case report was to document a case of delayed-type hypersensitivity reaction of the gingiva to chlorhexidine and review the literature on oral mucosal hypersensitivity reactions associated to chlorhexidine-containing oral hygiene products. A 58-year-old man presented with a well-demarcated erythematous area on the right upper anterior gingiva. Incisional biopsy was performed. Postoperatively, chlorhexidine digluconate gel was prescribed twice a day, but the patient did not use it because he experienced intense burning immediately after the first application. The microscopic diagnosis was nonspecific mucositis. Hypersensitivity reaction was suspected. The patient reported use of 0.004% chlorhexidine digluconate-based toothpaste twice a day in the past few years. A delayed-type hypersensitivity reaction to the toothpaste was hypothesized, and its use was discontinued. Chlorhexidine, the common ingredient of both the toothpaste and the gel, was considered the allergen. The literature was reviewed on chlorhexidine-induced oral hypersensitivity reactions. Two weeks after cessation of toothpaste use, complete remission of the lesion was observed without additional intervention. Four years later, no recurrence has been reported. The literature review yielded 7 studies reporting 20 patients with intraoral manifestations of hypersensitivity reactions associated with chlorhexidine-containing oral hygiene products. Clinicians should be aware that oral hygiene products containing even low concentrations of chlorhexidine might induce hypersensitivity reactions.

Comparative evaluation of the efficacy of Triphala gel and chlorhexidine digluconate gel in management of patients with chronic gingivitis: A randomized clinical trial

Aim: To evaluate the efficacy of Triphala gel and chlorhexidine digluconate gel in the management of patients with chronic gingivitis. Materials and Methods: A total of 46 subjects diagnosed with mild to moderate chronic gingivitis were enrolled for this study after obtaining their informed consent. In their first visit, a detailed case history was recorded including gingival index, plaque index, and sulcus bleeding index at baseline; then full-mouth scaling and polishing was performed on the first visit by a single calibrated examiner. These subjects were then randomly allocated using computer-generated random numbering sequence method into two groups. Subjects in group A received Triphala gel (HiOra-GA gel, Himalaya Drug, Bengaluru, India) and group B received chlorhexidine digluconate gel (Hexigel, ICPA Health Products, Mumbai, India) for home application. The posttreatment follow-up examinations for gingival index, plaque index, and sulcus bleeding index changes were assessed after 14 days at second visit and 28 days at third visit and compared with baseline data. Results: The mean gingival, plaque, and sulcus bleeding index scores significantly decreased after 14- and 28-day intervals as compared to baseline scores with no significant difference in both the groups. Conclusion: Both Triphala gel and chlorhexidine digluconate gel were effective when used along with oral prophylaxis in the management of subjects with chronic gingivitis. Hence, Triphala gel can be considered as an alternative to chlorhexidine digluconate gel in the management of chronic gingivitis.

The influence of two forms of chlorhexidine on the accuracy of contemporary electronic apex locators

BackgroundAccurate determination of working length (WL) is crucial for the success of endodontic therapy. The aim of this study was to determine the influence of 2% chlorhexidine digluconate solution, 2% chlorhexidine digluconate gel and 2% hypochlorite solution on the accuracy of two devices: the Raypex 5 and the ApexDal.MethodsTwenty-nine single-rooted human teeth were used in this study. The crowns were cut horizontally and embedded in an alginate mass. In each tooth, six endodontic measurements were made using two electronic apex locators (EALs): a Raypex 5 and an ApexDal. For each EAL, measurements were taken with the following products: 2% chlorhexidine solution (CHX-S group), 2% chlorhexidine gel (CHX-G group) and 2% NaOCl (NaOCl group). After performing an endodontic measurement, the endodontic instruments were stabilized with flow resin composite. Afterwards, the roots were removed from the alginate mass, and the apical one-third of each root was cut lengthways to recover the canal system. Last, the distance between the file tip and the apical foramen was measured under a microscope at 60 x magnification.ResultsStatistically significant differences were found between CHX-S and NaOCl and CHX-G and NaOCl, but no significant differences were detected between CHX-S and CHX-G during the testing of both devices. No statistically significant differences were observed between the Raypex 5 and ApexDal for all intracanal media tested.ConclusionThe EALs Raypex 5 and ApexDal had higher accuracy in the anatomical foramen of the root containing chlorhexidine in the gel or in the solution form than in the canal containing sodium hypochlorite.

Effects of a full-mouth disinfection protocol on the treatment of type-2 diabetic and non-diabetic subjects with mild-to-moderate periodontitis: one-year clinical outcomes

This study compared the clinical effects of a full-mouth disinfection (FMD) protocol for the treatment of mild-to-moderate periodontitis in type 2 diabetic and non-diabetic subjects for up to 1year. Secondary aim was to evaluate the effects of this therapy on the salivary levels of periodontal pathogens between diabetics and non-diabetics. Twenty-six type 2 diabetic subjects and 28 non-diabetic subjects with mild-to-moderate periodontitis received full-mouth scaling and root planing within 24h, application of chlorhexidine digluconate (CHX) gel in pockets and tongue plus CHX rinses for 14days. Clinical monitoring was performed at baseline, 3, 6, and 12months post-therapy. Salivary levels of red complex bacterial species were evaluated at baseline, 6, and 12months post-therapy by qPCR. Intention-to-treat analyses were performed for seven diabetics and three non-diabetics that did not return for the 12-month evaluation. Most clinical parameters improved significantly at 3, 6, and 12months post-therapies for both groups (p < 0.05). Overall, there were no significant differences in clinical parameters between groups after therapy (p > 0.05). At 1year, 39.3% and 50.0% of the non-diabetic and diabetic subjects, respectively, achieved the desired clinical endpoint for treatment (≤ 4 sites with probing depth ≥ 5mm) (primary outcome variable) (p > 0.05). FMD did not promote changes in the salivary levels of pathogens in either of the groups (p > 0.05). Levels of T. forsythia were lower in diabetic than in non-diabetic subjects at 6months post-therapy (p < 0.05). Type 2 diabetic subjects and systemically healthy subjects with mild-to-moderate periodontitis responded similarly to the proposed FMD protocol for up to 1year. There is a general thought that diabetics do not answer as well as non-diabetics to periodontal treatments. However, this study showed that diabetics and non-diabetics respond equally to the FMD protocol. ClinicalTrials.gov Identifier: NCT02643771.

Decontamination of mobile phones and electronic devices for health care professionals using a chlorhexidine/carbomer 940® gel

Though they reduce microorganism growth, current hospital disinfectants also damage many of today’s modern electronic devices such as tablets and smartphones. Herein, the efficacy of a new chlorhexidine digluconate gel (CDG) was tested as a disinfectant for mobile and electronic devices in a clinical environment. Specifically, Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa and methicillin resistant Staphylococcus aureus were used to infect the screen of eight smartphones. The CDG was prepared at concentrations of 2%, 4% and 6%, and tested on paper disks infected with these bacteria before being tested on the smartphones. The devices were disinfected with the CDG gel (4%) at two times: immediately and after 5 min of the bacterial contamination. In all cases, the CDG gel eliminated 100% of gram-positive and gram-negative microorganisms compared to the control (without any agent). In addition, the gel did not damage the smartphones. Therefore, our study suggests that the CDG gel may be applied to disinfect a wide range of electronic devices for health care professionals in the hospital environment.

Enabling an Accelerated Development Path for Chlorhexidine Digluconate Gel 7.1% w/w for the Prevention of Omphalitis

In 2012, the United Nations (UN), identified chlorhexidine as a Life-saving Commodity and called for the development of a chlorhexidine product suitable for the prevention of omphalitis (umbilical cord infection) in developing countries. In response, GlaxoSmithKline (GSK) set out to develop a chlorhexidine digluconate 7.1% w/w gel, in partnership with Save the Children. The vision was to develop a gel which could pass a stringent regulatory review thereby assuring a safe, effective, and quality product. Review under the European Medicines Agency’s (EMA) Article 58 pathway was pursued, with accelerated assessment granted. The regulatory dossier compiled literature-based evidence for clinical efficacy and safety, supplemented by GSK-generated in-vitro studies and a full CMC data package to support the quality. No new clinical trial data or in vivo non-clinical study data were submitted. A positive opinion from the EMA was received in 2016. The time from the initial UN call to EMA Positive Opinion was 3 years and 7 months.

Health care providers\u2019 perspectives regarding the use of chlorhexidine gel for cord care in neonates in rural Kenya: implications for scale-up

BackgroundThis paper explores the perspectives of health care providers regarding the use of 7.1% Chlorhexidine Digluconate (CHX) gel that releases 4% chlorhexidine for newborn umbilical cord care under a managed access program (MAP) implemented in Bungoma County of Kenya. Understanding the perspectives of providers regarding CHX is important since they play a key role in the health system and the fact that their views could be influenced by prior beliefs and inconsistent practices regarding umbilical cord care.MethodsData are from in-depth interviews conducted between April and June 2016 with 39 service providers from 21 facilities that participated in the program. The data were transcribed, typed in Word and analyzed for content. Analysis entailed identifying recurring themes based on the interview guides.ResultsUse of CHX gel for cord care in neonates was acceptable to the health care providers, with all of them supporting scaling up its use throughout the country. Their views were largely influenced by positive outcomes of the medication including fast healing of the cord as reported by mothers, minimal side effects, reduced newborn infections based on what their records showed and mothers’ reports, ease of use that made it simple for them to counsel mothers on how to apply it, positive feedback from mothers which demonstrated satisfaction with the medication, and general acceptance of the medication by the community. They further noted that successful scale-up of the medication required community sensitization, adequate follow-up mechanisms to ensure mothers use the medication correctly, addressing issues of staffing levels and staff training, developing guidelines and protocols for provision of the medication, adopting appropriate service delivery approaches to ensure all groups of mothers are reached, and ensuring constant supply of the medication.ConclusionUse of CHX gel for cord care in neonates is likely to be acceptable to health care workers in settings with high prevalence of neonatal morbidity and mortality arising from cord infections. In scaling up the use of the medication in such settings, some of the health systems requirements for successful roll-out can be addressed by programs while others are likely to be a persistent challenge.

Implementing at-scale, community-based distribution of misoprostol tablets to mothers in the third stage of labor for the prevention of postpartum haemorrhage in Sokoto State, Nigeria: Early results and lessons learned.

BackgroundPostpartum haemorrhage (PPH) is a leading cause of maternal death in Sokoto State, Nigeria, where 95% of women give birth outside of a health facility. Although pilot schemes have demonstrated the value of community-based distribution of misoprostol for the prevention of PPH, none have provided practical insight on taking such programs to scale.MethodsA community-based system for the distribution of misoprostol tablets (in 600ug) and chlorhexidine digluconate gel 7.1% to mother-newborn dyads was introduced by state government officials and community leaders throughout Sokoto State in April 2013, with the potential to reach an estimated 190,467 annual births. A simple outcome form that collected distribution and consumption data was used to assess the percentage of mothers that received misoprostol at labor through December 2014. Mothers’ conditions were tracked through 6 weeks postpartum. Verbal autopsies were conducted on associated maternal deaths.ResultsMisoprostol distribution was successfully introduced and reached mothers in labor in all 244 wards in Sokoto State. Community data collection systems were successfully operational in all 244 wards with reliable capacity to record maternal deaths. 70,982 women or 22% of expected births received misoprostol from April 2013 to December 2014. Between April and December 2013, 33 women (< 1%) reported that heavy bleeding persisted after misoprostol use and were promptly referred. There were a total of 11 deaths in the 2013 cohort which were confirmed as maternal deaths by verbal autopsies. Between January and December of 2014, a total 434 women (1.25%) that ingested misoprostol reported associated side effects.ConclusionIt is feasible and safe to utilize government guidelines on results-based primary health care to successfully introduce community distribution of life saving misoprostol at scale to reduce PPH and improve maternal outcomes. Lessons from Sokoto State’s at-scale program implementation, to assure every mother’s right to uterotonics, can inform scale-up elsewhere in Nigeria.

Evaluation of The Efficacy of Diode Laser, Chlorhexidine Digluconate Gel and Calcium Hydroxide Paste In The Disinfection Of Candida Albicans Infected Root Canals, In Vitro Study

the study aims to evaluate the efficacy of CHX-gel, Ca(OH) 2 and diode laser in eliminating C.albicans from the root canal system and hence to eliminate the chances of reinfection and minimize treatment time. Materials and methods : 180 single rooted anterior teeth were prepared and divided into 4 equal groups, the first was prepared to ISO 60 while the 2 nd -4 th were prepared only to ISO40, all the teeth were then sterilized and inoculated with C.albicans suspensions for 14 days, followed by evaluation of the starting bacterial counts in each tooth by means of colony forming units (CFU/ml), after this the groups 2-4 were prepared to ISO 40 MAF, using NaCl 9% in the 2 nd group, NaOCl 1% in the 3 rd and CHX 0.2% in the 4 th . Finally each of the 4 groups was divided into three subgroups (n=20), the first irradiated with diode laser, the second with injected with Ca(OH) 2 paste and the third injected with CHX-gel for 7 days, followed by estimation of the end bacterial counts in CFU/ml in canal lumen and in dentin. Results : the reduction of C.albicans was higher in all the groups after Ca(OH) 2 and CHX gel injection than with diode laser irradi- ation (p&lt;0.001, Chi-square test). After chemomechanical preparation a higher effectivity of the laser disinfection was shown and more specimen could reach the lower limit values, the effectiveness was also increased by the use of NaOCl or CHX as irrigants (p&lt;0.001).