Collagen Matrix With Tunnel Technique Compared to CTG for the Treatment of Periodontal Recessions

Not Applicable

Completed

• Conditions: Gingival Recession

• Registration Number: NCT02632240
• Lead Sponsor: Medical University of Silesia

Brief Summary

The aim of this study is to compare the efficacy of dental root coverage using the tunnel technique with connective tissue graft (CTG) and the same technique with collagen matrix for treatment of multiple gingival recessions Miller Class I and II.

This study is a randomized-controlled clinical trial of 6 months duration.

Detailed Description

According to the medical databases, there are limited randomized clinical trials comparing xenogenic collagen matrix and CTG used with the tunnel technique. The collagen matrix is a possible alternative to connective tissue graft.

The purpose of this clinical study is to compare short-term (3-6 months) outcomes of a root coverage using the tunnel technique with the collagen matrix and the same technique with CTG for the treatment of multiple recessions Miller class I and II.

Twenty eight patients are enrolled in the study. Patients in the test group are treated with xenogenic collagen matrix using the tunnel technique whereas patients in the control group with CTG. Clinical recordings are obtained at baseline and after 3 and 6 months. The percentage of average recession coverage (ARC) is evaluated after 3 and 6 months after the surgery.

Study Timeline

• Study Start: 2014-10
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Status Verified: 2015-12
• Study First Submitted: 2015-12-13
• Study First Submitted QC: 2015-12-15
• Study First Posted: 2015-12-16
• Last Update Submitted: 2015-12-16
• Last Update Posted: 2015-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• Presence of minimum two adjacent periodontal recessions Miller class I or II and at least 2 mm recessions depth.

Exclusion Criteria

• Approximal Plaque Index (API) > 15%,
• Sulcus Bleeding Index (SBI) > 10%,
• Systemic diseases with compromised healing potential or infectious diseases,
• Untreated periodontal conditions,
• Pregnant and lactating females.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Clinical attachment level (CAL)	6 months	Distance from the cemento enamel junction to the deepest point of the gingival sulcus

Secondary Outcome Measures

Name	Time	Method
The complete coverage of recessions (CRC)	6 months	The percentage rate of patients with complete coverage of all recessions (CRC)
Recession depth (RD)	6 months	Distance from the mid-facial point of the cemento-enamel junction to the free gingival margin
Recession width (RW)	6 months	Recession width horizontally at cemento-enamel junction level
Width of keratinized tissue (KTW)	6 months	Distance from the mucogingival junction to the gingival margin
Recession area (RA)	6 months	The area of a triangle with a width of recession as the base and a depth of the recession as the height.
the average percentage of root coverage (ARC)	6 months	The percentage of covered recession area.

Trial Locations

Locations (1)

Department of Periodontal and Oral Mucosa Diseases; 🇵🇱 Zabrze, Poland