Comparative evaluation of the clinical outcomes of xenogeneic pericardial collagen membrane enriched with Advanced platelet rich fibrin plus And De-Epithelialized Gingival Graft Along with Coronally Advanced Flap in the treatment of gingival recession- A prospective study
Overview
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Polimera Sanathana
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- 1. To assess and compare the changes in the recession height (RH) from baseline to 6 months, within CAF+A-PRF plus and XCM group.
Overview
Brief Summary
Gingival recession is a prevalent periodontal condition where the apical migration of gingival tissue causes exposure of the root surface and results in hypersensitivity, root caries , esthetic concerns to patients. The coronally advanced flap (CAF) along with connective tissue graft (CTG) is one of the most effective techniques for the management of Miller Class I and II recessions because it offers excellent esthetic results, highest root coverage. However, in patients with multiple gingival recession defects and having thin gingival phenotype, harvesting CTGs of adequate dimensions are clinically challenging due to the limited donor area. Recently the allogeneic or xenogeneic membranes or matrices have been employed along with platelet concentrates to improve root coverage and as an alternative treatment protocol to CTG . In this study we are proposing to compare the efficacy of combination of xenogeneic pericardial membrane and Advanced platelet rich fibrin plus with de-epithelized free gingival graft tissue along with coronally advanced flap in management of maxillary gingival recession.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- Participant and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 25.00 Year(s) to 55.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Systemically healthy subjects with an age range of 25-50 years.
- •Individuals diagnosed with recession defects in maxillary anteriors and premolars (Cairo’s RT1, RT2 classes of recession).
- •Sites with minimum depth of recession more than or equal to 2mm.
- •Isolated or multiple adjoining recession involving less than or equal to 3 teeth.
Exclusion Criteria
- •Sites with probing pocket depth more than or equal to 4mm.
- •2.Teeth with mobility and/or associated with trauma from occlusion.
- •Sites with dental caries and prosthetic restorations.
- •Patients who exhibit unacceptable oral hygiene compliance during/or after phase Ι therapy.
- •Pregnant and lactating women.
- •7.Patient known allergic response with Equine derived substances.
- •8.Patients with known platelet disorders or using any medication that are known to interfere with platelet function.
- •Patients with systemic conditions or disease influencing the course of periodontal disease and therapy.
Outcomes
Primary Outcomes
1. To assess and compare the changes in the recession height (RH) from baseline to 6 months, within CAF+A-PRF plus and XCM group.
Time Frame: Baseline to 6months
2. To assess and compare the changes in the recession height (RH) from baseline to 6 months, within CAF+DFGG group.
Time Frame: Baseline to 6months
3. To assess and compare the changes in the recession height from baseline to 6 months between CAF+A-PRF plus and XCM and CAF+DFGG groups
Time Frame: Baseline to 6months
Secondary Outcomes
- 1.To assess and compare the percentage of complete root coverage (CRC%) achieved at 6 months between the treatment groups.(2.To assess and compare the patient perception regarding pain following the treatment modalities by using visual analogue scale score (VAS-P))
Investigators
Polimera Sanathana
SRM dental college