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

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

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.

Study Overview

• Status: Completed
• Conditions: Periodontal Diseases
• Intervention / Treatment: Procedure: Procedure: Periodontal surgery with entire papilla preservation (EPP) technique; Device: EMD application; Device: Bone substitutes application

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: EPP with EMD+BS; 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; 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.; Device: EMD application; Application of Pref-Gel for 2 minutes and then the application of Enamel Matrix Derivatives (EMD) on the surgically exposed root surface.; Other Names: Amelogenins application; Device: Bone substitutes application; Following the application of EMD, filling the bone defect with bone substitutes.
Other: EPP without EMD+BS; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Dr. Aslan Private Perio Center
• Investigators: Principal Investigator: Serhat Aslan, DDS, PhD, Private Office Dr. Aslan

Publications and helpful links

General Publications

• Aslan S, Buduneli N, Cortellini P. Entire Papilla Preservation Technique: A Novel Surgical Approach for Regenerative Treatment of Deep and Wide Intrabony Defects. Int J Periodontics Restorative Dent. 2017 Mar/Apr;37(2):227-233. doi: 10.11607/prd.2584.
• Aslan S, Buduneli N, Cortellini P. Entire papilla preservation technique in the regenerative treatment of deep intrabony defects: 1-Year results. J Clin Periodontol. 2017 Sep;44(9):926-932. doi: 10.1111/jcpe.12780. Epub 2017 Aug 23.
• Aslan S, Buduneli N, Cortellini P. Clinical outcomes of the entire papilla preservation technique with and without biomaterials in the treatment of isolated intrabony defects: A randomized controlled clinical trial. J Clin Periodontol. 2020 Apr;47(4):470-478. doi: 10.1111/jcpe.13255. Epub 2020 Feb 3.

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2015
• Primary Completion (Actual): September 16, 2018
• Study Completion (Actual): June 4, 2019

Study Registration Dates

• First Submitted: April 15, 2019
• First Submitted That Met QC Criteria: April 17, 2019
• First Posted (Actual): April 22, 2019

Study Record Updates

• Last Update Posted (Actual): July 19, 2023
• Last Update Submitted That Met QC Criteria: July 18, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Periodontal Diseases
• Other Study ID Numbers: AslanPPC_RCT_01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No