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

Not Applicable

Completed

• Conditions: Periodontal Diseases
• Interventions: Device: EMD application; Device: Bone substitutes application

• Registration Number: NCT03923465
• Lead Sponsor: Dr. Aslan Private Perio Center

Brief Summary

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

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.

Study Timeline

• Study Start: 2015-04-04
• Primary Completion: 2018-09-16
• Study First Submitted: 2019-04-15
• Study First Submitted QC: 2019-04-17
• Study First Posted: 2019-04-22
• Study Completion: 2019-06-04
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-18
• Last Update Posted: 2023-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EPP with EMD+BS	EMD application	Using minimally invasive surgery, entire papilla preservation technique with the adjunctive use of amelogenins and bone substitutes
EPP with EMD+BS	Bone substitutes application	Using minimally invasive surgery, entire papilla preservation technique with the adjunctive use of amelogenins and bone substitutes

Primary Outcome Measures

Name	Time	Method
Clinical attachment level (CAL) gain	1-year	CAL is measured as the distance between cemento-enamel junction and the tip of the periodontal probe

Secondary Outcome Measures

Name	Time	Method
Post-surgical discomfort	1-week after surgery	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).