Entire Papilla Preservation Technique With and Without Biomaterials in the Treatment of Isolated Intrabony Defects

Study Overview
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Brief Summary
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The aim of this study is to investigate the clinical efficacy of entire papilla preservation technique with and without the adjunct of amelogenins (EMD) and bone substitutes.

Detailed Description
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The present study is designed as a single-centre, parallel group, randomized, controlled clinical trial comparing the efficacy of EPP with or without biomaterials. Each patient will contribute with a single intrabony defect. Three months after completion of initial periodontal therapy, all the experimental sites will be accessed with the EPP technique (Aslan et al., 2017a) and carefully debrided. EDTA gel will be applied on the instrumented root surfaces. A combination of EMD and deproteinized bovine-derived bone substitute will be applied in the test group (EPP EMD + BS), while the control group (EPP) will not receive any regenerative biomaterial. Patients will be enrolled in a stringent maintenance programme with recalls on a weekly basis for the first month and then monthly controls for professional tooth cleaning up to 1 year. Clinical parameters will be recorded immediately before regenerative surgery (baseline) and 12 months after the regenerative periodontal surgery.

Official Title
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Clinical Outcomes of the Entire Papilla Preservation Technique With and Without Biomaterials in the Treatment of Isolated Intrabony Defects: A Randomised-controlled Clinical Trial

Conditions
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Periodontal Diseases

Intervention / Treatment
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* Procedure: Procedure: Periodontal surgery with entire papilla preservation (EPP) technique
* Device: EMD application
* Device: Bone substitutes application


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Systemically healthy Clinical diagnosis of advanced periodontitis Having one isolated intrabony defect with probing depth (PD) ≥7 mm, clinical attachment level (CAL) ≥8 mm and at least 4 mm intrabony component involving predominantly the interproximal area of the affected tooth. Full-mouth plaque score (FMPS) ≤20%. Full-mouth bleeding score (FMBS) ≤20%. Exclusion Criteria: Smokers Patients with known systemic diseases such as diabetes and cardiovascular diseases or using medications that affect periodontal tissues, pregnant or lactating women One-wall intrabony defects Defects that involve buccal and lingual sites Presence of inadequate endodontic treatment and/or restoration in the relevant teeth.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: EPP with EMD+BS<br>Using minimally invasive surgery, entire papilla preservation technique with the adjunctive use of amelogenins and bone substitutes | Procedure: Procedure: Periodontal surgery with entire papilla preservation (EPP) technique<br>* After local anesthesia injection an modified flap is designed according to minimally invasive microsurgical techniques. After flap elevation, careful removal of granulation tissues from the periodontal defects is performed. Scaling and root planing of the involved dental roots is ensured and finally suture is placed.<br>Device: EMD application<br>* Application of Pref-Gel for 2 minutes and then the application of Enamel Matrix Derivatives (EMD) on the surgically exposed root surface.<br>* Other names: Amelogenins application;Device: Bone substitutes application<br>* Following the application of EMD, filling the bone defect with bone substitutes.<br>|
| Other: EPP without EMD+BS<br>Using minimally invasive surgery, entire papilla preservation technique without the adjunctive use of amelogenins and bone substitutes | Procedure: Procedure: Periodontal surgery with entire papilla preservation (EPP) technique<br>* After local anesthesia injection an modified flap is designed according to minimally invasive microsurgical techniques. After flap elevation, careful removal of granulation tissues from the periodontal defects is performed. Scaling and root planing of the involved dental roots is ensured and finally suture is placed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical attachment level (CAL) gain | CAL is measured as the distance between cemento-enamel junction and the tip of the periodontal probe | 1-year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-surgical discomfort | Post-surgical discomfort will be measured on a visual analog scale (VAS) and reported in millimeters. The subjects will be instructed to mark their level of pain on a line. The average change in discomfort level will be determined and compared between the two arms. A visual analogue scale (VAS) of 100 mm long will be used to evaluate the degree of discomfort (0=no pain/hardship; 100=unbearable pain/hardship). | 1-week after surgery |