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

Collagen Matrix With Tunnel Technique Compared to CTG for the Treatment of Periodontal Recessions - Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Gingival Recession
• Intervention / Treatment: Other: Surgery:The tunnel technique for covering gingival recession

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 Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Zabrze, Poland, 41-800
    • Department of Periodontal and Oral Mucosa Diseases

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group; Surgery:The tunnel technique for covering gingival recession. Graft: connective tissue.	Other: Surgery:The tunnel technique for covering gingival recession; The surgery starts with the sulcular incisions in the region of recessions, which enable access for the supraperiosteal preparation. The procedure is extended into the mucosal tissue using the tunneling knives. The partial-thickness flap is performed at the buccal site. Only the papillary regions are fully detached with the periosteum. The graft is placed into the tunnel and stabilized with absorbable sutures.The mobilized mucous flap is advanced coronally and stabilized with non-absorbable suspensory sutures.
Active Comparator: Study group; Surgery:The tunnel technique for covering gingival recession.Graft: xenogenic collagen matrix (Mucoderm).	Other: Surgery:The tunnel technique for covering gingival recession; The surgery starts with the sulcular incisions in the region of recessions, which enable access for the supraperiosteal preparation. The procedure is extended into the mucosal tissue using the tunneling knives. The partial-thickness flap is performed at the buccal site. Only the papillary regions are fully detached with the periosteum. The graft is placed into the tunnel and stabilized with absorbable sutures.The mobilized mucous flap is advanced coronally and stabilized with non-absorbable suspensory sutures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical attachment level (CAL)	Distance from the cemento enamel junction to the deepest point of the gingival sulcus	6 months

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The depth of gingival sulcus (PD)	Distance from the gingival margin to the deepest point of gingival sulcus	6 months

Collaborators and Investigators

• Sponsor: Medical University of Silesia
• Investigators: Study Chair: Marta Tanasiewicz, Professor, Department of Conservative Dentistry with Endodontics

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: December 13, 2015
• First Submitted That Met QC Criteria: December 15, 2015
• First Posted (Estimate): December 16, 2015

Study Record Updates

• Last Update Posted (Estimate): December 18, 2015
• Last Update Submitted That Met QC Criteria: December 16, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: gingival recession; connective tissue graft; collagen matrix; mucogingival surgery; tunnel technique
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Periodontal Atrophy; Gingival Recession
• Other Study ID Numbers: KNW-1-072/N/3/0