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

Gingival Recession Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02632240
• Other study ID #: KNW-1-072/N/3/0
• Status: Completed
• Phase: N/A
• First received: December 13, 2015
• Last updated: December 16, 2015
• Start date: October 2014
• Est. completion date: April 2015

Study information

• Verified date: December 2015
• Source: Medical University of Silesia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gingival Recession

Intervention

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.

Locations

Country	Name	City	State
Poland	Department of Periodontal and Oral Mucosa Diseases	Zabrze

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Silesia

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The depth of gingival sulcus (PD)	Distance from the gingival margin to the deepest point of gingival sulcus	6 months	No
Primary	Clinical attachment level (CAL)	Distance from the cemento enamel junction to the deepest point of the gingival sulcus	6 months	No
Secondary	Recession depth (RD)	Distance from the mid-facial point of the cemento-enamel junction to the free gingival margin	6 months	No
Secondary	Recession width (RW)	Recession width horizontally at cemento-enamel junction level	6 months	No
Secondary	Width of keratinized tissue (KTW)	Distance from the mucogingival junction to the gingival margin	6 months	No
Secondary	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	No
Secondary	the average percentage of root coverage (ARC)	The percentage of covered recession area.	6 months	No
Secondary	The complete coverage of recessions (CRC)	The percentage rate of patients with complete coverage of all recessions (CRC)	6 months	No