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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-04

Study Completion Date

2019-06-04

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.

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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.

Conditions

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Periodontal Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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EPP with EMD+BS

Using minimally invasive surgery, entire papilla preservation technique with the adjunctive use of amelogenins and bone substitutes

Group Type ACTIVE_COMPARATOR

Procedure: Periodontal surgery with entire papilla preservation (EPP) technique

Intervention Type PROCEDURE

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.

EMD application

Intervention Type DEVICE

Application of Pref-Gel for 2 minutes and then the application of Enamel Matrix Derivatives (EMD) on the surgically exposed root surface.

Bone substitutes application

Intervention Type DEVICE

Following the application of EMD, filling the bone defect with bone substitutes.

EPP without EMD+BS

Using minimally invasive surgery, entire papilla preservation technique without the adjunctive use of amelogenins and bone substitutes

Group Type OTHER

Procedure: Periodontal surgery with entire papilla preservation (EPP) technique

Intervention Type PROCEDURE

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.

Interventions

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Procedure: Periodontal surgery with entire papilla preservation (EPP) technique

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.

Intervention Type PROCEDURE

EMD application

Application of Pref-Gel for 2 minutes and then the application of Enamel Matrix Derivatives (EMD) on the surgically exposed root surface.

Intervention Type DEVICE

Bone substitutes application

Following the application of EMD, filling the bone defect with bone substitutes.

Intervention Type DEVICE

Other Intervention Names

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Amelogenins application

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No