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

Sponsor
Medical University of Silesia (Other)
Overall Status
Completed
CT.gov ID
NCT02632240
Collaborator
(none)
28
1
2
6
4.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Surgery:The tunnel technique for covering gingival recession
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
28 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
Collagen Matrix With Tunnel Technique Compared to CTG for the Treatment of Periodontal Recessions - Randomized Clinical Trial
Study Start Date :
Oct 1, 2014
Actual Primary Completion Date :
Apr 1, 2015
Actual Study Completion Date :
Apr 1, 2015

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Clinical attachment level (CAL) [6 months]

    Distance from the cemento enamel junction to the deepest point of the gingival sulcus

Secondary Outcome Measures

  1. Recession depth (RD) [6 months]

    Distance from the mid-facial point of the cemento-enamel junction to the free gingival margin

  2. Recession width (RW) [6 months]

    Recession width horizontally at cemento-enamel junction level

  3. Width of keratinized tissue (KTW) [6 months]

    Distance from the mucogingival junction to the gingival margin

  4. 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.

  5. the average percentage of root coverage (ARC) [6 months]

    The percentage of covered recession area.

  6. The complete coverage of recessions (CRC) [6 months]

    The percentage rate of patients with complete coverage of all recessions (CRC)

Other Outcome Measures

  1. The depth of gingival sulcus (PD) [6 months]

    Distance from the gingival margin to the deepest point of gingival sulcus

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Periodontal and Oral Mucosa Diseases Zabrze Poland 41-800

Sponsors and Collaborators

  • Medical University of Silesia

Investigators

  • Study Chair: Marta Tanasiewicz, Professor, Department of Conservative Dentistry with Endodontics

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Lukasz Gilowski, PhD DDS, Medical University of Silesia
ClinicalTrials.gov Identifier:
NCT02632240
Other Study ID Numbers:
  • KNW-1-072/N/3/0
First Posted:
Dec 16, 2015
Last Update Posted:
Dec 18, 2015
Last Verified:
Dec 1, 2015
Keywords provided by Lukasz Gilowski, PhD DDS, Medical University of Silesia
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 18, 2015