Alveolar Grafting Research Articles

Evaluation of alveolar ridge values with autogenous tooth graft and the provocative venture of allogeneic tooth graft from family members

Background Preserving the structural integrity of the alveolar ridge is paramount in ensuring the success of dental implant procedures and optimizing both aesthetic and physiological outcomes. This study aims to evaluate the efficacy of autologous dental grafting and explore intriguing results achieved through the utilization of allogeneic dental grafts obtained from a familial participant within the study’s framework. Methods Eleven patients necessitating bilateral dental extractions were enrolled in the study. Ten patients underwent autologous dental grafting on one side, while the contralateral side remained untreated. In the eleventh case, one side received autogenous dental grafting, while the other side was augmented with an allogeneic graft sourced from the patient’s son. Outcomes were monitored over a four-month period. Results Autogenous dental grafting led to a significant enhancement in bone density values and a reduction in osseous absorption rates(P<0.05) when compared to untreated sites among the ten patients who underwent the procedure. However, notable advancements were observed in patient 11 who received an allogeneic dental graft from a familial donor, suggesting potential superiority over autologous grafting in promoting bone regeneration. These findings underscore the promising prospects of employing allogeneic dental grafts sourced from family members to achieve optimal outcomes in alveolar ridge preservation. Conclusions The study underscores the significance of utilizing autologous dental grafts for preserving alveolar ridge dimensions. Importantly, the noteworthy improvement observed in patient outcomes resulting from the use of allogeneic dental grafts compared to autologous grafts raises several inquiries, particularly concerning the potential relationship between the patient and the donor. Trial registration The study is registered as a BRAZILIAN CLINICAL TEST RECORD (ReBEC): U1111-1305-2793 on 28-05-2024 ( https://ensaiosclinicos.gov.br/rg/RBR-65qchvs).

Metallic glasses show promise for bone grafting

Simulations showed that the mechanical and thermophysical properties of metallic glasses could make them an excellent choice for dental grafts.

Major clinical outcomes of the alveolar ridge preservation post-extraction sockets: a systematic review

Introduction: After tooth extraction, the alveolar ridge will commonly decrease in volume and change morphologically. These changes can be difficult or even impede the placement of dental implants and prosthetic rehabilitation. Minimizing bone remodeling means optimizing the esthetics and functional aspects, and mainly, the success of implant treatment. To avoid residual ridge resorption different techniques and bone graft materials have been proposed. Objective: It was to evaluate the efficiency of the many techniques of extraction socket treatment in the alveolar ridge dimension preservation. Methods: The PRISMA Platform systematic review rules were followed. The search was carried out from November 2023 to February 2024 in the Scopus, PubMed, Science Direct, Scielo, and Google Scholar databases. The quality of the studies was based on the GRADE instrument and the risk of bias was analyzed according to the Cochrane instrument. Results and Conclusion: A total of 158 articles were found, 62 articles were evaluated in full and 34 were included and developed in the present systematic review study. Considering the Cochrane tool for risk of bias, the overall assessment resulted in 28 studies with a high risk of bias and 22 studies that did not meet GRADE and AMSTAR-2. Most studies did not show homogeneity in their results, with X2=63.6%>50%. It was concluded that the application of autologous growth factor concentrate after surgical extraction offers an easy, low-cost, and efficient option for preserving the alveolar ridge. Therefore, the use of autologous growth factor concentrate by dentists during tooth extractions can be encouraged, especially when preservation of the alveolar ridge is necessary. The present study suggests that the alveolar graft technique may increase the risk of disease transmission, cost, and time of treatment. Several studies have stated that the graft material is not fully incorporated into the newly formed bone, indicating less vital bone tissue. Spontaneous scarring is still the most used feature since, in intact alveoli and small defects, it is a procedure that does not present significant losses that justify the use of edge preservation techniques. In larger defects, techniques after spontaneous healing, such as a block graft, can be used without the drawbacks of alveolar grafting, such as delayed healing and poor bone qualit.

Evaluating risk factors and complications in mandibular ramus block grafting: a retrospective cohort study

ObjectivesThis retrospective cohort study aimed to identify the complications and risk factors associated with alveolar grafting using autologous mandibular ramus grafts, guided by the research question: What are the complications encountered in patients undergoing alveolar bone grafting using autologous mandibular ramus block and what are the risk factors associated with the development of these complications?Materials and methodsThe study included 70 patients who underwent alveolar crest augmentation with autologous mandibular ramus block grafting. Intraoperative, early postoperative, and late postoperative complications were analyzed, as were various risk factors.ResultsThe results showed that the majority of patients had successful outcomes with minimal complications. Sex was found to significantly influence the visibility of the inferior alveolar nerve (IAN). Early postoperative complications were associated with IAN visibility and the use of a single screw for graft fixation. Late postoperative complications were significantly associated with the presence of infection.ConclusionThe findings emphasize the importance of careful surgical techniques, infection prevention, and patient selection in minimizing complications.Clinical relevanceThis article may contribute to clinicians’ and so patients’ understanding of potential risk factors associated with over all ramus block grafting procedure. Based on this information, clinicians can also improve their ability to manage risk factors and associated complications and compare ramus block grafting with other alternatives to determine the best treatment approach for that particular patient.

Viability Test of Hydroxyapatite Tooth Graft on Osteoblast cell culture

Surgery is required to restore bone loss brought on by regenerative periodontal diseases while retaining the patient's aesthetics. The bone deficits caused by periodontal disease have been repaired using a variety of transplant materials. One of the graft materials used is dentin since it resembles bone in terms of both organic and inorganic components. In order to evaluate the viability of dental grafts, this study intended to count the osteoblast cells that were still alive after a specific therapy. Osteoblast cell cultures in 42 well plates were employed in this work. The 42 well plate cell cultures were separated into seven groups for 24hour examinations and seven groups for 48 hour examinations in order to examine the cells using the MTT assay. Each group contained control cells, control media devoid of cells, and the treatment group, which received tooth transplant at doses of 8, 4, 2, 1, and 0.5mg/mL. Using an ELISA reader with a 595nm wavelength, the optical density of these cells was used to determine the viability of the cells. There are more than 50% of osteoblast cells in all concentrations, which is indicated by the number of these cells. The Shapiro-Wilk, Levene, and Oneway Anova tests were performed to assess the normality, uniformity, and degree of group differences in the data. This study demonstrates the biocompatibility of the tooth graft and the osteoblast cells.

Early Results on the Efficacy of Demineralized Bone Matrix, Bone Morphogenic Protein, and Freeze-dried Bone Chips in Alveolar Cleft Repair.

Conventional treatment for alveolar cleft repair is done using autologous iliac crest alveolar bone graft (ABG). However, this method may not be ideal in all patients. Analysis of the efficacy of a mixture of demineralized bone matrix (DBX), bone morphogenic protein (rhBMP-2), and freeze-dried bone chips (FDBC) as an alternative for alveolar cleft repair was performed. Consecutive patients from August 2019 to June 2022 undergoing early alveolar cleft repair, concomitant hard palate and alveolar cleft repair, secondary alveolar cleft repair, and regrafting from a previously failed ABG were analyzed. Computed tomography scans were performed to evaluate graft take at least 6 months postoperatively. Images were reviewed and scored. Alveolar graft height and graft thickness were recorded. A standardized scoring system was developed, with a score of 0 representing no graft take and 3 representing best possible graft take. Fifty-five consecutive alveolar clefts (43 patients) were identified as having undergone ABG and satisfied all the other inclusion criteria. Of these, 29 underwent first time ABG and 26 underwent redo ABG. The mean graft height and graft thickness recorded for all clefts was 2.2 and 2.0, respectively. Early results evaluating the efficacy of ABG using DBX, rhBMP-2, and FDBC show feasibility in regard to both graft height and thickness when using a maxillary computed tomography scan to measure the bone graft take. These results suggest that DBX, rhBMP-2, and FDBC may act as a versatile bone graft material in cleft care, although further studies are needed to determine long-term outcomes.

Consequence of Synthetic Bone Substitute Used for Alveolar Cleft Graft Reconstruction (Preliminary Clinical Study).

Background The outcome of alveolar grafting with synthetic bone substitute (Osteon III) in various bone defect volumes is highlighted. Methods A prospective study was accomplished on 55 patients (6-13 years of age) with unilateral alveolar bone cleft. Osteon III, consisting of hydroxyapatite and tricalcium phosphate, is used to reconstruct the defect. Alveolus defect diameter was calculated before surgery (V1), after 3 months (V2), and finally after 6 months (V3) postsurgery. In the t -test, a significant difference and correlation between V1, V2, and V3 are stated. A p- value of 0.01 is considered a significant difference between parameters. Results The degree of cleft is divided into three categories: small (9 cases), medium (20 patients), and large (26 cases).The bone volume of the clefted site is divided into three steps: volume 1: (mean 18.1091 mm 3 ); step 2: after 3 months, volume 2 resembles the amount of unhealed defect (mean 0.5109 mm 3 ); and the final bone volume assessment is made after 6 months (22.5455 mm 3 ). Both show statistically significant differences in bone volume formation. Conclusion An alloplastic bone substitute can also be used as a graft material because of its unlimited bone retrieval. Osteon III can be used to reconstruct the alveolar cleft smoothly and effectively.

Evaluation of Alveolar Bone Reconstruction In Clefts With Early Or Late Secondary Bone Grafting: Use Of The 3d Kamperos score.

There is still no consensus on the optimal age for alveolar grafting. In order to decide on the success of this graft, the best known radiographic assessments lacks precision. Kamperos recently proposed a 3D CBCT score that simultaneously assesses alveolar bone height and thickness, as well as the nasal floor level. The aim of this study was to apply this new score and compare it between an early secondary alveolar grafting « ESAG » (4-7y) and a late secondary alveolar grafting « LSAG » (8-11y) surgery group. A total of 32 cases of ESAG and 17 of LSAG were analysed. On 3D imaging, the median age of ESAGs was 10 years and 15 years for LSAGs. In the ESAGs, 78% of the permanents canines were not on the arch compared to 18% in the LSAGs. In both groups, the reconstruction of the nasal floor was very adequate but the height and thickness appeared less good in the ESAGs. The final score was higher in LSAG (Chi2, P < 0.005). The analysis of the alveolar bone with the Kamperos score is accurate and relevant but it should preferably be performed in the permanent dentition phase. This is because the area of rhizalysis of the primary teeth and the follicular sac of the erupting permanent teeth influence the presence of effective bone.

Effect of Platelet-rich Plasma on the Clinical Success of Alveolar Grafts in Patients With Cleft Lip and Palate: A Systematic Review and Meta-Analysis.

This study assessed the effect of platelet-rich plasma (PRP) on the clinical success of alveolar grafts in patients with cleft lip and palate. In this meta-analysis, a search of the literature was conducted in Medline, Scopus, ISI Web of Science, and Cochrane Central Register of Controlled Trials for randomized clinical trials using PRP or platelet-rich fibrin (PRF) along with autogenous bone for alveolar ridge grafts in patients with cleft lip and palate. The methodological quality of the studies was analyzed using Cochrane's risk of the bias assessment tool. The extracted data underwent meta-analysis using the random-effects model. Of a total of 2256 articles retrieved, 12 met the eligibility criteria and were enrolled; out of which 6 did not undergo meta-analysis due to heterogeneous data. The percentage of defects filled by bone graft was 0.648% (95% confidence interval: -0.15 to 1.45), which was not statistically significant ( P =0.115). Subgroup analysis showed no significant difference based on the use of PRF or PRP ( P =0.28), type of cleft (unilateral/bilateral; P =0.56), or type of radiographic modality (3D/2D; P =0.190). Meta-regression analysis showed that the duration of follow-up and the difference in the mean age of patients did not have a significant effect on the results (R=0, I2: high). The application of PRP/PRF in combination with autogenous bone graft did not have a significant effect on the percentage of alveolar cleft filled by a bone graft. Future clinical studies are required to further elucidate the effect of PRP in the regeneration of alveolar clefts.

Healing of particulate allografts mixed with platelet concentrates in ridge preservation and sinus lift: a prospective histomorphometric study

The objective of the present study was to evaluate the bone quality of sinus and alveolar grafts following filling with particulate allogenous bone (DFDBA 300-500μm) and platelet concentrate (platelet-rich fibrin, PRF). A prospective interventional clinical study was carried out. A total of 40 bone cores, 2mm in diameter, were taken from 21 patients: 22 from grafted alveoli, 7 from grafted sinus sites, and 11 from native bone used as a control. Fixed, paraffin-embedded samples were subjected to histological staining with hematoxylin-eosin and Masson's trichrome. Bone maturity of the samples was evaluated by two independent operators using histomorphometric analysis. There existed a greater proportion of lamellar neoformed bone than woven neoformed bone as the healing time increased. Moreover, there was also an increasing proportion of newly formed bone in the grafted sockets as a function of healing time (average: 41.22%≤5 months, 55.89%˃5 months). Resorption of DFDBA particles also appears to be correlated with healing time in the grafted socket (average: 15.43≤5 months, 13.72%˃5 months). In conclusion, performing sinus lift and alveolar socket preservation techniques using DFDBA and PRF results in high quality, mature bone tissue according to histological criteria.

Evaluation of Radiographic Outcomes of Alveolar Graft Associated with Premaxillary Osteotomy Performed with rhBMP-2.

To evaluate the influence of filling material and timing of surgery on radiograph outcomes of alveolar grafting with premaxillary osteotomy. The null hypothesis was that radiographic outcomes would be similar with both rhBMP-2 (rhBMP-2G) and cancellous bone from the iliac crest (IG), regardless of the timing of surgery. Cross-sectional study with consecutive sampling of 56 periapical or occlusal radiographs taken 12 months after surgery. A single tertiary craniofacial center. Twenty-eight patients with complete bilateral cleft lip and palate and mean age of 13 years. The individuals underwent bilateral alveolar grafting associated with premaxillary osteotomy (AG + PO) with rhBMP-2 or cancellous bone from the iliac crest. Experienced maxillofacial surgeons used the same surgical technique in both groups. AG + PO were assigned as success or failure by 3 blinded raters based on modified Bergland and SWAG scales. The influence of filling materials and timing of surgery on radiographic outcomes was verified by Fisher's exact test and chi-square test (P < .05). There was no significance variation between the mean age of participants in the rhBMP-2G and IG (P = .471). Scales showed almost perfect reliability (agreement rate = 96.4%; K = 0.85). rhBMP-2G and IG had similar success rates with modified Bergland scale (85.7% and 82.1%) and SWAG scale (92.9% and 82.1%), respectively. However, only modified Bergland scale found influence of age on radiographic outcomes (P = .025). AG + PO performed with rhBMP-2 and iliac crest bone showed similar radiographic success rates, regardless of the timing of surgery.

Three-Dimensional Impression of Biomaterials for Alveolar Graft: Scoping Review

Craniofacial bone defects are one of the biggest clinical challenges in regenerative medicine, with secondary autologous bone grafting being the gold-standard technique. The development of new three-dimensional matrices intends to overcome the disadvantages of the gold-standard method. The aim of this paper is to put forth an in-depth review regarding the clinical efficiency of available 3D printed biomaterials for the correction of alveolar bone defects. A survey was carried out using the following databases: PubMed via Medline, Cochrane Library, Scopus, Web of Science, EMBASE, and gray literature. The inclusion criteria applied were the following: in vitro, in vivo, ex vivo, and clinical studies; and studies that assessed bone regeneration resorting to 3D printed biomaterials. The risk of bias of the in vitro and in vivo studies was performed using the guidelines for the reporting of pre-clinical studies on dental materials by Faggion Jr and the SYRCLE risk of bias tool, respectively. In total, 92 publications were included in the final sample. The most reported three-dimensional biomaterials were the PCL matrix, β-TCP matrix, and hydroxyapatite matrix. These biomaterials can be combined with different polymers and bioactive molecules such as rBMP-2. Most of the included studies had a high risk of bias. Despite the advances in the research on new three-dimensionally printed biomaterials in bone regeneration, the existing results are not sufficient to justify the application of these biomaterials in routine clinical practice.

Alveolar cleft reconstruction with vomerine bone: two surgical procedures in one step: a case series

Aim: Iliac crest (IC) is the most common source of bone for alveolar cleft repair, as it allows for harvesting a large amount of cancellous bone with a high rate of favorable outcomes. Its drawback is the donor-site morbidity. We propose a new technique for alveolar cleft grafting using vomerine bone (VB), which, through bone grafting, reconstructs the alveolus with the VB and simultaneously corrects the nasal septum deviation. Method: We performed 18 alveolar reconstructions with VB in patients with a small bony defect and septal deviation, which would benefit from septoplasty. A matched control group with IC bone grafting was selected. Panoramic X-rays were used for vertical assessment of ossification with the Bergland scale and CT scans for the evaluation of the thickness of the grafted area in the VB and IC groups and compared with an independent samples T-test. A paired T-test compared angular measurements of the septal deviation pre- and post- vomerine grafting. Results: All grafts healed uneventfully, with no complications at the donor site and respiratory function was improved. There was no statistically significant difference in ossification height between VB and IC, the alveolar thickness at the occlusal and middle third was higher with IC. Septal deviation was reduced significantly. Conclusion: Alveolar graft from VB seems to be a viable alternative to IC in patients who present with a mild bony alveolar defect in addition to septal deviation, allowing combined procedures while reducing the morbidity of the donor site.

Outcomes of permanent canines on the cleft side after secondary alveolar grafting using different materials in complete unilateral cleft lip and palate.

The prevalence of impaction of the permanent canine on the cleft side (PCCS) ranges from 12-35% after alveolar bone grafting (ABG). PCCSs usually develop above other permanent teeth in the alveolar process, gradually becoming vertical until they reach the occlusal plane. The type of cleft, hypodontia of lateral incisor on the cleft side, slower PCCS root development, and genetic factors are predictors of impaction and/or its ectopic eruption. To compare the behavior of PCCS in individuals with complete unilateral cleft lip and palate (UCLP) subjected to secondary alveolar grafting (SAG) with different materials. This retrospective longitudinal study analyzed 120 individuals undergoing SAG with iliac crest bone, rhBMP-2, and mandibular symphysis. The individuals were selected at a single center and equally divided into three groups. Panoramic radiographs were analyzed by the Dolphin Imaging 11.95 software to measure PCCS angulation and PCCS height from the occlusal plane at two different timepoints. No statistical significance was found between grafting materials (P=0.416). At T1, the PCCS height from the occlusal plane was greater for rhBMP-2 and mandibular symphysis compared to iliac crest bone. The lateral incisor on the cleft side was not related to success or lack of eruption of PCCS (P=0.870). Impaction rates of PCCS were similar for the materials studied. Absence of the lateral incisor on the cleft side did not prevent spontaneous eruption of PCCSs.

Unilateral Cleft lip and Palate: Long-Term Results of the Malek Technique.

To review at 18 years-old the results of surgery and follow-up of children born in our hospital with unilateral cleft lip and palate (uCLP). They were operated at the time by the same surgeon, following the same primary surgical procedure (Malek). Retrospective cohort study. Tertiary Children's Hospital. All children born with uCLP between 1996 and 2001 and operated in our hospital. Syndromic children were excluded. Results of the primary surgery, ear–nose–throat interventions, maxillo-facial surgery and final phonatory results. Seventy-nine files of children born with a cleft were reviewed: 34 were taken into consideration for uCLP: 15 right and 19 left. They were operated in two stages, following the inverse Malek procedure. Sixty per cent had a fistula. Eighty-eight percent had grommets. Ninety-seven percent had an alveolar graft at a median age of nine (5-10) and 22% underwent a Le Fort osteotomy. Seven percent were operated for a pharyngeal flap, 29% for a secondary lip surgery at a mean age of 12.8 and 29% for a late rhinoplasty at a mean age of 14.8 years. A median of 5.7 multidisciplinary consultations was realized with a median number of general anesthesia of 7.1 (4-13). This retrospective study shows that the Malek procedure for children born with uCLP is related to a high risk of fistula but good long-term phonatory results. Twenty percent of children were operated for a Le Fort procedure and one-third for a secondary lip procedure and rhinoplasty.

Alveolar regeneration induced by calcium phosphate ceramics after dental avulsion: Study in young rats

Dental grafts are alternatives to dental loss in children, while growing and developing. The objective of this work was to evaluate in vitro and in vivo in the dental socket, the bioactivity of biphasic calcium phosphate (BCP) obtained from fish bone, pure and associated with Nb2O5. The in vitro study was performed after immersion in 1.5SBF, by XRD and SEM. Young Wistar rats were used for in vivo study, simulating a dental avulsion by exodontia. The alveoli of the upper right incisor were filled with granulated BCP or BCP/Nb2O5. In controls, the alveoli were filled with clot of the animal itself. At 7, 15, 30, 60 and 120 days after surgery, the animals were killed and the jaws were collected, fixed, embedded in paraffin, and stained with H&E, Azan and immunostained for osteocalcin. The in vitro test showed growth of apatite on the ceramics. In vivo analyses showed that the materials were biocompatible and stimulated osteogenesis at all periods. It is concluded that the BCP and BCP/Nb2O5 ceramics were active in bone formation and maturation after exodontia. In cases of tooth loss by avulsion, in children, clinicians should consider the use of calcium phosphate-based grafts, with slow resorption, and excellent bioperformance, to maintain the dimensions of the alveolar ridge, favoring future implants.

Can the Age Affect the Regenerations Carried Out With Dental Graft?

Introduction: The tooth extraction is followed by marked osseous changes of the residual alveolar ridge including severe bone alterations both in height and width. For this reason has been developed the Alveolar Ridge Preservation (ARP). It is important for the dental surgeon to know how the alveolar crest changes when a ARP is performed. The metabolism affects bone repair reaction. To prevent alveolar ridge dimensional changes, since numerous graft materials have been suggested. In the last years, a growing interest in teeth material, due to his bone similarity, has been observed as a valuable alternative to synthetic biomaterials. Aim: We want to assess if the age affects the regenerations ARP using dental graft. Material and Methods: In this study 115 histologies from different patients (59 Male and 56 female) were analyzed splitting in six different age range: 20-30, 30-40, 40-50, 50-60, 60-70, over 70. The statistical analysis was effectuated using a P-value analyzing the differences between each age each other and cumulative. Results: The statistical differences are not relevant even if the sample’s number is limited only in two groups the differences are slightly above the significant value. The differences between the average value is not significative P &lt;0,05. Conclusion: Any differences is evident between different ages.

Reconstruction of Oronasal Fistula with Tongue Flap: A Cleft Palate Report.

Oronasal fistula can persist after conventional secondary alveolar bone graft surgery, which may lead to functional issues, such as regurgitation of fluids from the oral to the nasal cavity. This manuscript describes a clinical case of a patient with a bilateral cleft lip and palate that underwent tongue graft surgery for closure of an oronasal fistula after three failed local mucosa flap surgeries. The multidisciplinary treatment was comprised of orthodontic treatment, mucosa and alveolar grafts for palate closure and aesthetic rehabilitation of the anterior maxillary teeth. Smile aesthetics were noticeably improved, enhancing the patient’s self-perception and confidence.

Enhanced bone regeneration by Aloe vera gel conjugated barnacle cement protein composite hyaluronic acid hydrogel based hydroxyapatite derived from cuttlefish bone

Injectable Aloe vera gel W (AGW®)-conjugated Barnacle Cement Protein (BCP) composite Hyaluronic Acid (HA) hydrogels provide local periodontal tissue for bone filling in periodontal surgery. We developed a novel type of injectable self-supported hydrogel (2 mg/ml of AGW®-BCP/HA) based cuttlefish bone derived hydroxyapatite (CBH) for dental graft, which could good handling property, biodegradation or biocompatibility with the hydrogel disassembly and provided efficient cell adhesion activity and no inflammatory responses. Herein, the aim of this work was to evaluate bone formation following implantation of CBH and collagen membrane in rabbit calvarias defects. Eight male New Zealand rabbits were used and four circular calvarias defects were created on each animal. Defects were filled with different graft materials: 1) collagen membrane, 2) collagen membrane with CBH, 3) collagen membrane with bovine bone hydroxyapatite (BBH), and 4) control. The animals were sacrificed after 2 and 8 weeks of healing periods for histologic analysis. Both sites receiving CBH and BBH showed statistically increased augmented volume and new bone formation (p&lt;0.05). However, there was no statistical difference in new bone formation between the CBH, BBH and collagen membrane group at all healing periods. Within the limits of this study, collagen membrane with CBH was an effective material for bone formation and space maintaining in rabbit calvarias defects.

A systematic review on regenerative alveolar graft materials in clinical trials: Risk of bias and meta-analysis

BackgroundAlveolar cleft grafting is a necessary procedure to restore bone defects. Randomized clinical trials (RCTs) are regarded as a golden standard for investigating the efficacy of treatments. Nevertheless, risk of bias (RoB) can still affect the validity of these trials. We aimed to conduct a systemic review of all control trials (CTs) using regenerative materials for alveolar cleft reconstructions to evaluate their RoB and perform a meta-analysis of new bone formation. MethodsCochrane Oral Health Group's Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (PubMed), EMBASE AND Google Scholar were searched up to October 2020. Thereafter, the articles underwent quality assessment (according to the Jadad scale and the Delphi list) for the evaluation of the RoB. ResultsA total of 15 trials met the inclusion criteria, none of which reached a full score. Of these, 20% didn't randomize the trails, 73,33% failed to describe the way of randomization, and none reported the double-blinded criteria. Furthermore, allocation concealment (99.9%), intention to treat (100%), and patient awareness (100%) were inadequately described. The meta-analysis found no significant difference between regenerative materials and iliac crest graft. ConclusionThis review showed high RoB in CTs implying quality improvement of CTs is necessary. Meta-analysis showed no significant difference between the regenerative materials and autogenous grafts.