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

Primary Purpose

Gingival Recession

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Surgery:The tunnel technique for covering gingival recession
Sponsored by
Medical University of Silesia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingival Recession focused on measuring gingival recession, mucogingival surgery, collagen matrix, connective tissue graft, tunnel technique

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Periodontal and Oral Mucosa Diseases

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Control group

Study group

Arm Description

Surgery:The tunnel technique for covering gingival recession. Graft: connective tissue.

Surgery:The tunnel technique for covering gingival recession.Graft: xenogenic collagen matrix (Mucoderm).

Outcomes

Primary Outcome Measures

Clinical attachment level (CAL)
Distance from the cemento enamel junction to the deepest point of the gingival sulcus

Secondary Outcome Measures

Recession depth (RD)
Distance from the mid-facial point of the cemento-enamel junction to the free gingival margin
Recession width (RW)
Recession width horizontally at cemento-enamel junction level
Width of keratinized tissue (KTW)
Distance from the mucogingival junction to the gingival margin
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.
the average percentage of root coverage (ARC)
The percentage of covered recession area.
The complete coverage of recessions (CRC)
The percentage rate of patients with complete coverage of all recessions (CRC)

Full Information

First Posted
December 13, 2015
Last Updated
December 16, 2015
Sponsor
Medical University of Silesia
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1. Study Identification

Unique Protocol Identification Number
NCT02632240
Brief Title
Collagen Matrix With Tunnel Technique Compared to CTG for the Treatment of Periodontal Recessions
Official Title
Collagen Matrix With Tunnel Technique Compared to CTG for the Treatment of Periodontal Recessions - Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Silesia

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession
Keywords
gingival recession, mucogingival surgery, collagen matrix, connective tissue graft, tunnel technique

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Surgery:The tunnel technique for covering gingival recession. Graft: connective tissue.
Arm Title
Study group
Arm Type
Active Comparator
Arm Description
Surgery:The tunnel technique for covering gingival recession.Graft: xenogenic collagen matrix (Mucoderm).
Intervention Type
Other
Intervention Name(s)
Surgery:The tunnel technique for covering gingival recession
Intervention Description
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.
Primary Outcome Measure Information:
Title
Clinical attachment level (CAL)
Description
Distance from the cemento enamel junction to the deepest point of the gingival sulcus
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Recession depth (RD)
Description
Distance from the mid-facial point of the cemento-enamel junction to the free gingival margin
Time Frame
6 months
Title
Recession width (RW)
Description
Recession width horizontally at cemento-enamel junction level
Time Frame
6 months
Title
Width of keratinized tissue (KTW)
Description
Distance from the mucogingival junction to the gingival margin
Time Frame
6 months
Title
Recession area (RA)
Description
The area of a triangle with a width of recession as the base and a depth of the recession as the height.
Time Frame
6 months
Title
the average percentage of root coverage (ARC)
Description
The percentage of covered recession area.
Time Frame
6 months
Title
The complete coverage of recessions (CRC)
Description
The percentage rate of patients with complete coverage of all recessions (CRC)
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
The depth of gingival sulcus (PD)
Description
Distance from the gingival margin to the deepest point of gingival sulcus
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marta Tanasiewicz, Professor
Organizational Affiliation
Department of Conservative Dentistry with Endodontics
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Periodontal and Oral Mucosa Diseases
City
Zabrze
ZIP/Postal Code
41-800
Country
Poland

12. IPD Sharing Statement

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

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