The Use of Mucograft® to Treat Gingival Recession

February 3, 2018 updated by: Damascus University

Clinical Applications of 3D Collagen Matrix (Mucograft®) in the Management of Gingival Recession: a Randomized Controlled Trial

Twenty patients with gingival recession will be enrolled in this trial. Gingival recession will be treated in one side by applying Mucograft® with coronally advanced flap (CAF) while on the opposite side a connective tissue graft (from the palate) will be applied with a CAF.

Patients will be followed for 3 and 6 months by measuring the clinical indexes and statistical analyses will be performed to compare the results and to assess the success of Mucograft®.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Many surgical techniques have used to treat gingival recession such aas repositioned flaps, autologous soft tissue grafts (connective tissue graft or free gingival grafts) or allografts like acellular dermal which can be used as substitutes for palatal donor tissue. Mucograft® (3D collagen matrix) is also an allograft from porcine origin and is designed for soft tissue regeneration and considered the ideal solution to autogenous soft tissue grafts and it provides an ideal matrix for blood vessel and soft tissue ingrowth.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Syrian Arab Republic
      • Damascus, Syrian Arab Republic, DM20AM18
        • Department of Periodontics, University of Damascus Dental School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Presence of Type I or II (Miller Classification) of gingival recession

Exclusion Criteria:

  • Smoking
  • Pregnancy or lactating
  • Presence of any systematic diseases can affect the periodontal surgery.
  • Subjects with significant moderate to severe periodontal disease.
  • Patients under orthodontic treatment
  • Presence of restorative materials (e.g. crown)
  • Effectiveness of frenum
  • Subjects have failed to maintain good plaque control.
  • Subjects having previous surgical treatment for covering the recession in the chosen area.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mucograft
One side of the mouth will be subjected to Mucograft in this split-mouth study design.
Procedure: Mucograft
This method of grafting will be used to treat the gingival recession using coronally advanced flaps.
Active Comparator: Connective tissue graft
The opposite side of the mouth will be subjected to a connective tissue graft.
Procedure: Connective Tissue Graft
This will be used in the traditional manner to correct gingival recession

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the Clinical Attachment Level Index
Time Frame: Measurements will be done at :(1) one hour before applying the graft, (2) at three months exactly post-operatively and (3) at six months exactly post-operatively
Clinical Attachment Level is dependent on measuring the pocket depth as well as the amount of gingival recession using specific tools. The measurement is going to be recorded in millimeters.
Measurements will be done at :(1) one hour before applying the graft, (2) at three months exactly post-operatively and (3) at six months exactly post-operatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Probing Depth
Time Frame: Measurements will be done at :(1) one hour before applying the graft, (2) at three months exactly post-operatively and (3) at six months exactly post-operatively
Probing depth is going to be measuring using a specific tool (UNC-15 probe).
Measurements will be done at :(1) one hour before applying the graft, (2) at three months exactly post-operatively and (3) at six months exactly post-operatively
Change in Gingival Recession
Time Frame: Measurements will be done at :(1) one hour before applying the graft, (2) at three months exactly post-operatively and (3) at six months exactly post-operatively
Gingival recession is measured from the cemento-enamel junction to the gingival margin of the recessed tissues.
Measurements will be done at :(1) one hour before applying the graft, (2) at three months exactly post-operatively and (3) at six months exactly post-operatively
Change in Gingival Biotype
Time Frame: Measurements will be done at :(1) one hour before applying the graft, (2) at three months exactly post-operatively and (3) at six months exactly post-operatively
Gingival biotype is assessed by an endodontic file which used to determine the thickness of the gingival tissues (i.e. thick or thin).
Measurements will be done at :(1) one hour before applying the graft, (2) at three months exactly post-operatively and (3) at six months exactly post-operatively
Change in Root Coverage Index
Time Frame: Measurements will be done at :(1) one hour before applying the graft, (2) at three months exactly post-operatively and (3) at six months exactly post-operatively
The amount of root exposure will be measured and compared to the total length of the root
Measurements will be done at :(1) one hour before applying the graft, (2) at three months exactly post-operatively and (3) at six months exactly post-operatively
Change in Resistance to Muscular Pull
Time Frame: Measurements will be done at :(1) one hour before applying the graft, (2) at three months exactly post-operatively and (3) at six months exactly post-operatively
The cheeks or lips are going to be retracted by hand or by a mirror in order to see the movement of the free gingival tissues. The movement will be esitmated in millimeters.
Measurements will be done at :(1) one hour before applying the graft, (2) at three months exactly post-operatively and (3) at six months exactly post-operatively
Change in Color Match Index
Time Frame: Measurements will be done at :(1) one hour before applying the graft, (2) at three months exactly post-operatively and (3) at six months exactly post-operatively
Measurements will be done at :(1) one hour before applying the graft, (2) at three months exactly post-operatively and (3) at six months exactly post-operatively
Shrinkage index at three months
Time Frame: Measurements will be done at two time points to calculate the amount of shrinkage :(1) at one hour before applying the graft, (2) at three months exactly post-operatively.
Measurements will be done at two time points to calculate the amount of shrinkage :(1) at one hour before applying the graft, (2) at three months exactly post-operatively.
Shrinkage index at six months
Time Frame: Measurements will be done at two time points to calculate the amount of shrinkage :(1) at one hour before applying the graft, (2) at six months exactly post-operatively.
Measurements will be done at two time points to calculate the amount of shrinkage :(1) at one hour before applying the graft, (2) at six months exactly post-operatively.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Damascus University

Investigators

  • Principal Investigator: Haydar Barakat, DDS MSc, PhD Student in Periodontics, University of Damascus Dental School, Damascus, Syria
  • Study Director: Suleiman Dayoub, DDS MSc PhD, Associate Professor of Periodontics, Department of Peridontics, Univ. of Damascus Dental School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2016

Primary Completion (Actual)

April 1, 2017

Study Completion (Actual)

December 20, 2017

Study Registration Dates

First Submitted

November 29, 2016

First Submitted That Met QC Criteria

December 5, 2016

First Posted (Estimate)

December 8, 2016

Study Record Updates

Last Update Posted (Actual)

February 6, 2018

Last Update Submitted That Met QC Criteria

February 3, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UDDS-Perio-01-2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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