Treatment Of Periodontal Defects Research Articles

Histological evaluation of a biomimetic material in bone regeneration after one year from graft

The use of substitute materials is one of the solutions used in periodontology for the reconstruction of intrabony defects. Advances in scientific research gave rise to a new generation of biomaterials of synthetic origin stoichiometrically unstable and therefore really absorbable. Our research is directed precisely towards a biomaterial synthesis, Engipore® (Finceramica, Faenza, Italy) which is a bone substitute of the latest hydroxyapatite-based generation, that possesses chemical and morphological properties similar to those of natural bone in the treatment of infrabony periodontal defects. Aim of this study was to evaluate the efficacy of Engipore® in the treatment of intrabony periodontal defects. The study was conducted on 100 parodontopatics patients, which had gingival pockets of at least infrabonies 8/10 mm. The histological evaluation was performed with samples after one year from the graft. The histological samples collected after one year showed an abundant new bone formation, with mature lamellar bone tissue surrounding the residual particles of Engipore® that appear completely osteointegrated. The surrounding connective tissue shows no signs of inflammation. The results obtained in our research demonstrated that, after a proper selection of patients and lesions, and applying an adequate surgical technique, this type of biomaterial in the treatment of periodontal defects acts in an optimal manner as a filler inducing the formation of new bone as evidenced by histological examinations.

Platelet-rich plasma in periodontal defect treatment after extraction of impacted mandibular third molars: Retraction.

[This retracts the article on p. 139 in vol. 3, PMID: 23833487.].

Periodontal Tissue Engineering Strategies Based on Nonoral Stem Cells

Periodontal disease is an inflammatory disease which constitutes an important health problem in humans due to its enormous prevalence and life threatening implications on systemic health. Routine standard periodontal treatments include gingival flaps, root planning, application of growth/differentiation factors or filler materials and guided tissue regeneration. However, these treatments have come short on achieving regeneration ad integrum of the periodontium, mainly due to the presence of tissues from different embryonic origins and their complex interactions along the regenerative process. Tissue engineering (TE) aims to regenerate damaged tissue by providing the repair site with a suitable scaffold seeded with sufficient undifferentiated cells and, thus, constitutes a valuable alternative to current therapies for the treatment of periodontal defects. Stem cells from oral and dental origin are known to have potential to regenerate these tissues. Nevertheless, harvesting cells from these sites implies a significant local tissue morbidity and low cell yield, as compared to other anatomical sources of adult multipotent stem cells. This manuscript reviews studies describing the use of non-oral stem cells in tissue engineering strategies, highlighting the importance and potential of these alternative stem cells sources in the development of advanced therapies for periodontal regeneration.

A Clinical Investigation of Demineralized Bone Matrix Putty for Treatment of Periodontal Bony Defects in Humans

The goal of this study was to evaluate the effectiveness of demineralized bone matrix (DBM) putty, consisting of demineralized human bone allograft matrix in a carrier of bovine collagen and alginate, for the treatment of periodontal defects in humans. Twenty subjects with at least one site having a probing depth ≥ 6 mm and radiographic evidence of bony defect depth > 3 mm were included. The infrabony defects were grafted with DBM putty bone graft. The following clinical parameters were assessed at baseline and 6 months posttreatment: probing depth (PD), gingival recession (GR), and clinical attachment level (CAL). Bone fill was evaluated using transgingival probing and standardized radiographs taken at baseline and 6 months posttreatment. The 6-month evaluation showed a significant PD reduction of 3.27 ± 1.67 mm and clinical attachment gain of 2.27 ± 1.74 mm. Bone sounding measurements showed a mean clinical bone defect fill of 2.93 ± 1.87 mm and a mean radiographic bone fill of 2.55 ± 2.31 mm. The use of DBM putty was effective for treatment of periodontal bony defects in humans. Significant improvement in CAL, PD, and bone fill was observed at 6 months compared to baseline.

Mesenchymal Stem Cells from iPS Cells Facilitate Periodontal Regeneration

Mesenchymal stem cells (MSC) have been considered as a potential therapy for the treatment of periodontal defects arising from periodontitis. However, issues surrounding their accessibility and proliferation in culture significantly limit their ability to be used as a mainstream treatment approach. It is therefore important that alternative, easily accessible, and safe populations of stem cells be identified. Controlled induction of induced pluripotent stem cells (iPSC) into MSC-like cells is emerging as an attractive source for obtaining large populations of stem cells for regenerative medicine. We have successfully induced iPSC to differentiate into MSC-like cells. The MSC-like cells generated satisfied the International Society of Cellular Therapy’s minimal criteria for defining multipotent MSC, since they had plastic adherent properties, expressed key MSC-associated markers, and had the capacity to undergo tri-lineage differentiation. Importantly, the resulting iPSC-MSC-like cells also had the capacity, when implanted into periodontal defects, to significantly increase the amount of regeneration and newly formed mineralized tissue present. Our results demonstrate, for the first time, that MSC derived from iPSC have the capacity to aid periodontal regeneration and are a promising source of readily accessible stem cells for use in the clinical treatment of periodontitis.

Absorbable Collagen Membranes for Periodontal Regeneration

Guided tissue regeneration (GTR) with bioabsorbable collagen membranes (CM) is commonly used for the treatment of periodontal defects. The objective of this systematic review of randomized clinical trials was to assess the clinical efficacy of GTR procedures with CM, with or without bone substitutes, in periodontal infrabony defects compared with that of open flap debridement (OFD) alone. Primary outcomes were tooth loss and gain in clinical attachment level (CAL). Screening of records, data extraction, and risk-of-bias assessments were performed by two reviewers. Weighted mean differences were estimated by random effects meta-analysis. We included 21 reports on 17 trials. Risk of bias was generally high. No data were available for the primary outcome tooth loss. The summary treatment effect for change in CAL for GTR with CM compared with OFD was 1.58 mm (95% CI, 1.27 to 1.88). Despite large between-trial heterogeneity (I2 = 75%, p < .001), all trials favored GTR over OFD. No differences in treatment effects were detected between trials of GTR with CM alone and trials of GTR with CM in combination with bone substitutes (p for interaction, .31). GTR with CM, with or without substitutes, may result in improved clinical outcomes compared with those achieved with OFD alone. Our findings support GTR with CM for the treatment of infrabony periodontal defects.

Platelet‐Derived Growth Factor Promotes Periodontal Regeneration in Localized Osseous Defects: 36‐Month Extension Results From a Randomized, Controlled, Double‐Masked Clinical Trial

Recombinant human platelet-derived growth factor (rhPDGF) is safe and effective for the treatment of periodontal defects in short-term studies up to 6 months in duration. We now provide results from a 36-month extension study of a multicenter, randomized, controlled clinical trial evaluating the effect and long-term stability of PDGF-BB treatment in patients with localized severe periodontal osseous defects. A total of 135 participants were enrolled from six clinical centers for an extension trial. Eighty-three individuals completed the study at 36 months and were included in the analysis. The study investigated the local application of β-tricalcium phosphate scaffold matrix with or without two different dose levels of PDGF (0.3 or 1.0 mg/mL PDGF-BB) in patients possessing one localized periodontal osseous defect. Composite analysis for clinical and radiographic evidence of treatment success was defined as percentage of cases with clinical attachment level (CAL) ≥2.7 mm and linear bone growth (LBG) ≥1.1 mm. The participants exceeding this composite outcome benchmark in the 0.3 mg/mL rhPDGF-BB group went from 62.2% at 12 months, 75.9% at 24 months, to 87.0% at 36 months compared with 39.5%, 48.3%, and 53.8%, respectively, in the scaffold control group at these same time points (P <0.05). Although there were no significant increases in CAL and LBG at 36 months among all groups, there were continued increases in CAL gain, LBG, and percentage bone fill over time, suggesting overall stability of the regenerative response. PDGF-BB in a synthetic scaffold matrix promotes long-term stable clinical and radiographic improvements as measured by composite outcomes for CAL gain and LBG for patients possessing localized periodontal defects ( ClinicalTrials.gov no. CT01530126).

Asymmetric PDLLA membranes containing Bioglass® for guided tissue regeneration: Characterization and in vitro biological behavior

ObjectiveIn the treatment of periodontal defects, composite membranes might be applied to protect the injured area and simultaneously stimulate tissue regeneration. This work describes the development and characterization of poly(d,l-lactic acid)/Bioglass® (PDLLA/BG) composite membranes with asymmetric bioactivity. We hypothesized that the presence of BG microparticles could enhance structural and osteoconductivity performance of pure PDLLA membranes. MethodsThe membranes were prepared by an adjusted solvent casting method that promoted a non-uniform distribution of the inorganic component along the membrane thickness. In vitro bioactive behavior (precipitation of an apatite layer upon immersion in simulated body fluid, SBF), SEM observation, FTIR, swelling, weight loss and mechanical properties of the developed biomaterials were evaluated. Cell behavior on the membranes was assessed using both human bone marrow stromal cells and human periodontal ligament cells. ResultsJust the BG rich face of the composite membranes induced the precipitation of bone-like apatite in SBF, indicating that this biomaterial exhibit asymmetric osteoconductive properties. SEM images, DNA content and metabolic activity quantification revealed an improved cell adhesion and proliferation on the composite membranes. Composite membranes also stimulated cell differentiation, mineralization, and production of extracellular matrix and calcium nodules, suggesting the positive effect of adding the bioactive microparticles in the PDLLA matrix. SignificanceThe results indicate that the proposed asymmetric PDLLA/BG membranes could have potential to be used in guided tissue regeneration therapies or in orthopedic applications, with improved outcomes.

Using Bioactive Glasses for the Treatment of Periodontal Intrabony Defects may Result in Modest Probing Depth Reduction and Clinical Attachment Level Gain Compared to Open Flap Debridement

An evaluation of bioactive glass in the treatment of periodontal defects: a meta-analysis of randomized controlled clinical trials. Sohrabi K, Saraiya V, Laage TA, Harris M, Blieden M, Karimbux N. J Periodontol 2012;83:453-64. Hsun-Liang Chan, DDS, MS, Hom-Lay Wang, DDS, PhD* To determine whether the use of bioactive glass in the treatment of periodontal intrabony defects results in more PD reduction and CAL gain than other treatment methods Information not available Systematic review with meta-analysis Level 2: limited-quality, patient-oriented evidence Grade C: Consensus, disease-oriented evidence, usual practice, expert opinion, or case series for studies of diagnosis, treatment, prevention, or screening

Five years clinical results following treatment of human intra-bony defects with an enamel matrix derivative: A randomized controlled trial

Introduction. Emdogain® represents an extracellular matrix derivative that controls and promotes periodontal regeneration. Several studies have demonstrated that the treatment of periodontal defects with Emdogain® leads to improvements in clinical parameters. However, long-time clinical trials establishing clinical usefulness of Emdogain® are scarce. Therefore, the present randomized split mouth, controlled study was undertaken to evaluate the effectiveness of Emdogain® as an adjunct to open flap debridement for the treatment of intra-bony defects over a period of 5 years. Materials and methods. The study population consisted of 15 chronic periodontitis patients with bilateral interproximal osseous defects. The test group was treated by open flap debridement with EDTA 24% (PrefGel®) followed by enamel matrix derivative (Emdogain®). The control group was treated by open flap debridement with EDTA 24% (PrefGel®). Results. After 1 and 5 years, both the test and control groups showed significant mean PPD reduction. A greater reduction in mean Probing Pocket Depth (PPD) was observed in the test group (3.84 ± 1.05) as compared to the control group (1.92 ± 0.35). The mean Clinical Attachment Level (CAL) gain of 3.18 ± 0.87 mm was observed in the test group, while the control group displayed mean CAL gain of 1.60 ± 0.54 mm. The observed differences were found to be statistically significant in both the groups (p < 0.05). Percentage bone fill was significantly increased at 12 months post-surgery in test group (66.66 ± 7.8%) as compared to control group (31.71 ± 4.1%). Conclusion. The treatment with Emdogain resulted in a significantly higher CAL gain and PPD reduction in comparison with OFD and PrefGel®.

Minimally Invasive Surgical Techniques in Periodontal Regeneration

A review of the current scientific literature was undertaken to evaluate the efficacy of minimally invasive periodontal regenerative surgery in the treatment of periodontal defects. The impact on clinical outcomes, surgical chair-time, side effects and patient morbidity were evaluated.An electronic search of PUBMED database from January 1987 to December 2011 was undertaken on dental journals using the key-word “minimally invasive surgery”. Cohort studies, retrospective studies and randomized controlled clinical trials referring to treatment of periodontal defects with at least 6 months of follow-up were selected. Quality assessment of the selected studies was done through the Strength of Recommendation Taxonomy Grading (SORT) System.Ten studies (1 retrospective, 5 cohorts and 4 RCTs) were included. All the studies consistently support the efficacy of minimally invasive surgery in the treatment of periodontal defects in terms of clinical attachment level gain, probing pocket depth reduction and minimal gingival recession. Six studies reporting on side effects and patient morbidity consistently indicate very low levels of pain and discomfort during and after surgery resulting in a reduced intake of pain-killers and very limited interference with daily activities in the post-operative period.Minimally invasive surgery might be considered a true reality in the field of periodontal regeneration. The observed clinical improvements are consistently associated with very limited morbidity to the patient during the surgical procedure as well as in the post-operative period. Minimally invasive surgery, however, cannot be applied at all cases. A stepwise decisional algorithm should support clinicians in choosing the treatment approach.

Scaffold-free microtissues: differences from monolayer cultures and their potential in bone tissue engineering.

Cell-based therapies for bone augmentation after tooth loss and for the treatment of periodontal defects improve healing defects. Usually, osteogenic cells or stem cells are cultivated in 2D primary cultures, before they are combined with scaffold materials, even though this means a loss of the endogenous 3D microenvironment for the cells. Moreover, the use of single-cell suspensions for the inoculation of scaffolds or for the direct application into an area of interest has the disadvantages of low initial cell numbers and susceptibility to unwanted cellular distribution, respectively. We addressed the question whether an alternative to monolayer cultures, namely 3D microtissues, has the potential to improve osteogenic tissue engineering and its clinical outcome. By contrast, to monolayer cultures, osteogenic differentiation of 3D microtissues is enhanced by mimicking in vivo conditions. It seems that the osteogenic differentiation in microtissues is enhanced by strong integrin-extracellular matrix interaction and by stronger autocrine BMP2 signaling. Moreover, microtissues are less prone to wash out by body fluids and allow the precise administration of large cell numbers. Microtissue cultures have closer characteristics with cells in vivo and their enhanced osteogenic differentiation makes scaffold-free microtissues a promising concept in osteogenic tissue engineering. Microtissues are particularly suitable for tissue engineering because they improve seeding efficiency of biomaterials by increasing the cell load of a scaffold. This results in accelerated osteogenic tissue formation and could contribute to earlier implant stability in mandibular bone augmentation.

Clinical and radiographic evaluation of intrabony periodontal defect treatment by open flap debridement alone or in combination with nanocrystalline hydroxyapatite bone substitute

The aim of this study has been to compare the clinical and radiographic outcome of periodontal intrabony defect treatment by open flap debridement alone or in combination with nanocrystalline hydroxyapatite bone substitute application. Thirty patients diagnosed with advanced periodontits were divided into two groups: the control group (OFD), in which an open flap debridement procedure was performed and the test group (OFD+NHA), in which defects were additionally filled with nanocrystalline hydroxyapatite bone substitute material. Plaque index (PI), gingival index (GI), bleeding on probing (BOP), pocket depth (PD), gingival recession (GR) and clinical attachment level (CAL) were measured prior to, then 6 and 12months following treatment. Radiographic depth and width of defects were also evaluated. There were no differences in any clinical and radiographic parameters between the examined groups prior to treatment. After treatment, BOP, GI, PD, CAL, radiographic depth and width parameter values improved statistically significantly in both groups. The PI value did not change, but the GR value increased significantly after treatment. There were no statistical differences in evaluated parameters between OFD and OFD+NHA groups 6 and 12months after treatment. Within the limits of the study, it can be concluded that the additional use of nanocrystalline hydroxyapatite bone substitute material after open flap procedure does not improve clinical and radiographic treatment outcome.

Vitamin C treatment promotes mesenchymal stem cell sheet formation and tissue regeneration by elevating telomerase activity

Cell sheet engineering has been developed as an alternative approach to improve mesenchymal stem cell-mediated tissue regeneration. In this study, we found that vitamin C (Vc) was capable of inducing telomerase activity in periodontal ligament stem cells (PDLSCs), leading to the up-regulated expression of extracellular matrix type I collagen, fibronectin, and integrin β1, stem cell markers Oct4, Sox2, and Nanog as well as osteogenic markers RUNX2, ALP, OCN. Under Vc treatment, PDLSCs can form cell sheet structures because of increased cell matrix production. Interestingly, PDLSC sheets demonstrated a significant improvement in tissue regeneration compared with untreated control dissociated PDLSCs and offered an effective treatment for periodontal defects in a swine model. In addition, bone marrow mesenchymal stem cell sheets and umbilical cord mesenchymal stem cell sheets were also well constructed using this method. The development of Vc-mediated mesenchymal stem cell sheets may provide an easy and practical approach for cell-based tissue regeneration.

Periodontal regeneration using an injectable bone cement combined with BMP-2 or FGF-2

Periodontitis is a frequently diagnosed oral disease characterized by bone resorption and soft tissue loss around teeth. Unfortunately, currently available therapies only slow or arrest progress of the disease. Ideally, treatment of periodontal defects should be focused on complete regeneration of the lost tissues [(bone and periodontal ligament (PDL)]. As a result, this study used intrabony defects to evaluate the regenerative potential of an injectable macroporous calcium phosphate cement (CaP) in combination with bone morphogenetic protein-2 (BMP-2) or fibroblast growth factor-2 (FGF-2). After creating 30 periodontal defects in 15 Wistar rats, three treatment strategies were conducted: application of CaP only, CaP + BMP-2 and CaP + FGF-2. Animals were euthanized after 12 weeks and processed for histology and histomorphometry. Using CaP alone resulted in limited effects on PDL and bone healing. CaP + BMP-2 showed a good response for bone healing; a significant 2.4 fold increase in bone healing score was observed compared to CaP. However, for PDL healing, CaP + BMP-2 treatment showed no difference compared to the CaP group. The best results were observed with the combined treatment of CaP + FGF-2, which showed a significant 3.3 fold increase in PDL healing score compared to CaP + BMP-2 and a significant 2.6 fold increase compared to CaP. For bone healing, CaP + FGF-2 showed a significant 1.9 fold increase compared to CaP but no significant difference was noted compared to the CaP + BMP-2 group. The combination of a topical application of FGF-2 and an injectable CaP seems to be a promising treatment modality for periodontal regeneration.

An Evaluation of Bioactive Glass in the Treatment of Periodontal Defects: A Meta‐Analysis of Randomized Controlled Clinical Trials

The regenerative surgical treatment of intrabony defects caused by periodontal disease has been examined in several systematic reviews and meta-analyses. The use of bioactive glass (BG) as a graft material to treat intrabony defects has been reported, but all data have not been synthesized and compiled. Our objective was to systematically review the literature on the use of BG for the treatment of intrabony defects and to perform a meta-analysis of its efficacy. A search of PubMed, EMBASE, and Cochrane Database of Systematic Reviews, as well as a manual search of recently published periodontology journals, were conducted to identify randomized controlled trials of the use of BG in the treatment of intrabony and furcation defects. Criteria included publication in English, follow-up duration of ≥6 months, baseline and follow-up measures of probing depth (PD) and clinical attachment levels (CAL) with 95% confidence intervals (CIs), and an appropriate control arm. Twenty-five citations were identified, 15 of which were included in the final analysis. Data, including study methods and results, as well as CONSORT (Consolidated Standards of Reporting Trials) criteria, were extracted from eligible studies and cross-checked by at least two reviewers. Meta-analyses of eligible studies were performed to ascertain summary effects for changes in PD and CAL among experimental and control groups, using the mean change plus standard deviation for each study. Pooled analyses showed that BG was superior to control for both measures: the mean (95% CIs) difference from baseline to follow-up between BG and controls was 0.52 mm (0.27, 0.78, P <0.0001) in reduction for PD and 0.60 mm (0.18, 1.01, P = 0.005) in gain for CAL. Analyses of CAL revealed heterogeneity across studies (I(2) = 60.5%), although studies reporting PD measures were homogeneous (I(2) = 0.00%). CAL heterogeneity appeared secondary to active controls versus open flap debridement (OFD) alone and to defect-type modifying BG treatment success. Per subgroup analyses, the benefit of BG over control treatment was highly significant only in studies comparing BG to OFD (P <0.0001), with mean difference change in CAL being 1.18 mm (95% CI = 0.74, 1.62 mm) between the BG and OFD group. Treatment of intrabony defects with BG imparts a significant improvement in both PD and CAL compared to both active controls and OFD.

One-Step Purification of Recombinant Human Amelogenin and Use of Amelogenin as a Fusion Partner

Amelogenin is an extracellular protein first identified as a matrix component important for formation of dental enamel during tooth development. Lately, amelogenin has also been found to have positive effects on clinical important areas, such as treatment of periodontal defects, wound healing, and bone regeneration. Here we present a simple method for purification of recombinant human amelogenin expressed in Escherichia coli, based on the solubility properties of amelogenin. The method combines cell lysis with recovery/purification of the protein and generates a >95% pure amelogenin in one step using intact harvested cells as starting material. By using amelogenin as a fusion partner we could further demonstrate that the same method also be can explored to purify other target proteins/peptides in an effective manner. For instance, a fusion between the clinically used protein PTH (parathyroid hormone) and amelogenin was successfully expressed and purified, and the amelogenin part could be removed from PTH by using a site-specific protease.

Platelet-rich plasma in periodontal defect treatment after extraction of impacted mandibular third molars.

Purpose:The extraction of mesioangular impacted third molars may cause multiple periodontal defects at the distal root of the second molar. Platelet-rich plasma (PRP) is a material containing many autologous growth factors that may be used in repairing and preventing periodontal complications at the distal root of the second molar adjacent to the extracted third molar.Materials and Methods:We analyzed the effects of autologous PRP on periodontal tissues after extraction of the third molar in 18 young patients (age, 20–30 years). Inclusion criteria were the presence of a pocket distal to the mandibular second molar with a probing depth [3] of 7.5 mm and a probing attachment level [3] of 6 mm.Results:We observed, at 12 weeks after surgery, a notable reduction in the probing depth and an improvement in the probing attachment level in those cases treated with PRP compared with the controls, as well as formation of new bone tissue in the bone defect.Conclusion:We showed that PRP is effective in inducing and accelerating bone regeneration for the treatment of periodontal defects at the distal root of the mandibular second molar after surgical extraction of a mesioangular, deeply impacted mandibular third molar.

Platelet‐rich fibrin and bovine porous bone mineral vs. platelet‐rich fibrin in the treatment of intrabony periodontal defects

Bovine porous bone mineral (BPBM) is a xenograft that has been successfully utilized in periodontal regeneration. Platelet-rich fibrin (PRF) is a leukocyte and platelet preparation that concentrates various polypeptide growth factors and therefore has the potential to be used as regenerative treatment for periodontal defects. The purpose of this study was to examine the suitability of autologous PRF as regenerative treatment for periodontal intrabony defects in humans and to examine the ability of BPBM to augment the regenerative effects exerted by PRF. Using a split-mouth design, 17 paired intrabony defects were randomly treated either with PRF or with PRF-BPBM combination. Re-entry surgeries were performed at 6 mo. Primary study outcomes were changes in pocket depth, attachment level and defect fill. Preoperative pocket depths, attachment levels and transoperative bone measurements were similar for the PRF and PRF-BPBM groups. Postsurgical measurements revealed a significantly greater reduction in pocket depth in the PRF-BPBM group (4.47±0.78 mm on buccal and 4.29±0.82 mm on lingual sites) when compared with the PRF group (3.35±0.68 mm on buccal and 3.24±0.73 mm on lingual sites). The PRF-BPBM group presented with significantly greater attachment gain (3.82±0.78 mm on buccal and 3.71±0.75 mm on lingual sites) than the PRF group (2.24±0.73 mm on buccal and 2.12±0.68 mm on lingual sites). Defect fill was also greater in the PRF-BPBM group (4.06±0.87 mm on buccal and 3.94±0.73 mm on lingual sites) than in the PRF group (2.21±0.68 mm on buccal and 2.06±0.64 mm on lingual sites). The results of this study indicate that PRF can improve clinical parameters associated with human intrabony periodontal defects, and BPBM has the ability to augment the effects of PRF in reducing pocket depth, improving clinical attachment levels and promoting defect fill.

Multi-centre, randomized clinical trial on the efficacy and safety of recombinant human platelet-derived growth factor with β-tricalcium phosphate in human intra-osseous periodontal defects

the objective of the study was to evaluate the safety and efficacy of a formulation containing recombinant human platelet-derived growth factor (rhPDGF-BB) and β-tricalcium phosphate (β-TCP) in patients with periodontal defects and to compare it with those of β-TCP alone. in this double-blind, prospective, parallel, active-controlled, randomized, multi-centre clinical trial, 54 patients with periodontal osseous defects were randomly assigned to rhPDGF-BB+β-TCP or β-TCP. Following periodontal surgery, respective implantation was performed. The primary and secondary end points of treatment were evaluated at the third and the sixth month. among the outcome measures, the extent of linear bone growth (p<0.01) and per cent bone fill (p<0.004) at the sixth month over baseline were significantly higher in the rhPDGF-BB+β-TCP group when compared with the β-TCP group. Similarly, it also resulted in significantly higher area under the curve clinical attachment level gain at 0-6 months (p<0.01), CAL gain and greater reduction in probing depth at the third and the sixth month than that with β-TCP treatment alone. The incidence of adverse events was similar in both the groups and no serious adverse events were reported in any of the patients. rhPDGF-BB+β-TCP is safe and effective in the treatment of periodontal defects. It increases bone formation and soft tissue healing (clinicaltrials.gov, number NCT00496847; CTRI No.: CTRI/2008/091/000152).