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The Use of Mucograft® to Treat Gingival Recession

Primary Purpose

Gingival Recession

Status

Completed

Phase

Not Applicable

Locations

Syrian Arab Republic

Study Type

Interventional

Intervention

Mucograft

Connective Tissue Graft

About this trial

This is an interventional treatment trial for Gingival Recession focused on measuring gingival graft, free gingival graft, coronally advanced flap, reduced keratinized gingiva

Eligibility Criteria

20 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Department of Periodontics, University of Damascus Dental School

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mucograft

Connective tissue graft

Arm Description

One side of the mouth will be subjected to Mucograft in this split-mouth study design.

The opposite side of the mouth will be subjected to a connective tissue graft.

Outcomes

Primary Outcome Measures

Change in the Clinical Attachment Level Index

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.

Secondary Outcome Measures

Change in Probing Depth

Probing depth is going to be measuring using a specific tool (UNC-15 probe).

Change in Gingival Recession

Gingival recession is measured from the cemento-enamel junction to the gingival margin of the recessed tissues.

Change in Gingival Biotype

Gingival biotype is assessed by an endodontic file which used to determine the thickness of the gingival tissues (i.e. thick or thin).

Change in Root Coverage Index

The amount of root exposure will be measured and compared to the total length of the root

Change in Resistance to Muscular Pull

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.

Change in Color Match Index

Shrinkage index at three months

Shrinkage index at six months

Full Information

NCT ID

NCT02986191

First Posted

November 29, 2016

Last Updated

February 3, 2018

Sponsor

Damascus University

1. Study Identification

Unique Protocol Identification Number

NCT02986191

Brief Title

The Use of Mucograft® to Treat Gingival Recession

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2018

Overall Recruitment Status

Completed

Study Start Date

August 2016 (Actual)

Primary Completion Date

April 2017 (Actual)

Study Completion Date

December 20, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Damascus University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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®.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gingival Recession

Keywords

gingival graft, free gingival graft, coronally advanced flap, reduced keratinized gingiva

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Mucograft

Arm Type

Experimental

Arm Description

One side of the mouth will be subjected to Mucograft in this split-mouth study design.

Arm Title

Connective tissue graft

Arm Type

Active Comparator

Arm Description

The opposite side of the mouth will be subjected to a connective tissue graft.

Intervention Type

Procedure

Intervention Name(s)

Mucograft

Intervention Description

This method of grafting will be used to treat the gingival recession using coronally advanced flaps.

Intervention Type

Procedure

Intervention Name(s)

Connective Tissue Graft

Intervention Description

This will be used in the traditional manner to correct gingival recession

Primary Outcome Measure Information:

Title

Change in the Clinical Attachment Level Index

Description

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.

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

Secondary Outcome Measure Information:

Title

Change in Probing Depth

Description

Probing depth is going to be measuring using a specific tool (UNC-15 probe).

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

Title

Change in Gingival Recession

Description

Gingival recession is measured from the cemento-enamel junction to the gingival margin of the recessed tissues.

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

Title

Change in Gingival Biotype

Description

Gingival biotype is assessed by an endodontic file which used to determine the thickness of the gingival tissues (i.e. thick or thin).

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

Title

Change in Root Coverage Index

Description

The amount of root exposure will be measured and compared to the total length of the root

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

Title

Change in Resistance to Muscular Pull

Description

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.

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

Title

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

Title

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.

Title

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Haydar Barakat, DDS MSc

Organizational Affiliation

PhD Student in Periodontics, University of Damascus Dental School, Damascus, Syria

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Suleiman Dayoub, DDS MSc PhD

Organizational Affiliation

Associate Professor of Periodontics, Department of Peridontics, Univ. of Damascus Dental School

Official's Role

Study Director

Facility Information:

Facility Name

Department of Periodontics, University of Damascus Dental School

City

Damascus

ZIP/Postal Code

DM20AM18

Country

Syrian Arab Republic

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

20417009

Citation

Herford AS, Akin L, Cicciu M, Maiorana C, Boyne PJ. Use of a porcine collagen matrix as an alternative to autogenous tissue for grafting oral soft tissue defects. J Oral Maxillofac Surg. 2010 Jul;68(7):1463-70. doi: 10.1016/j.joms.2010.02.054. Epub 2010 Apr 22.

Results Reference

background

PubMed Identifier

21837302

Citation

Nevins M, Nevins ML, Kim SW, Schupbach P, Kim DM. The use of mucograft collagen matrix to augment the zone of keratinized tissue around teeth: a pilot study. Int J Periodontics Restorative Dent. 2011 Jul-Aug;31(4):367-73.

Results Reference

background

PubMed Identifier

22254233

Citation

Rocchietta I, Schupbach P, Ghezzi C, Maschera E, Simion M. Soft tissue integration of a porcine collagen membrane: an experimental study in pigs. Int J Periodontics Restorative Dent. 2012 Feb;32(1):e34-40.

Results Reference

background

PubMed Identifier

21721988

Citation

Cardaropoli D, Tamagnone L, Roffredo A, Gaveglio L. Treatment of gingival recession defects using coronally advanced flap with a porcine collagen matrix compared to coronally advanced flap with connective tissue graft: a randomized controlled clinical trial. J Periodontol. 2012 Mar;83(3):321-8. doi: 10.1902/jop.2011.110215. Epub 2011 Jul 1.

Results Reference

background

PubMed Identifier

23050490

Citation

Jepsen K, Jepsen S, Zucchelli G, Stefanini M, de Sanctis M, Baldini N, Greven B, Heinz B, Wennstrom J, Cassel B, Vignoletti F, Sanz M. Treatment of gingival recession defects with a coronally advanced flap and a xenogeneic collagen matrix: a multicenter randomized clinical trial. J Clin Periodontol. 2013 Jan;40(1):82-9. doi: 10.1111/jcpe.12019. Epub 2012 Oct 10.

Results Reference

background

PubMed Identifier

24597764

Citation

McGuire MK, Scheyer ET. Randomized, controlled clinical trial to evaluate a xenogeneic collagen matrix as an alternative to free gingival grafting for oral soft tissue augmentation. J Periodontol. 2014 Oct;85(10):1333-41. doi: 10.1902/jop.2014.130692. Epub 2014 Mar 5.

Results Reference

background

PubMed Identifier

26469812

Citation

McGuire MK, Scheyer ET. Long-Term Results Comparing Xenogeneic Collagen Matrix and Autogenous Connective Tissue Grafts With Coronally Advanced Flaps for Treatment of Dehiscence-Type Recession Defects. J Periodontol. 2016 Mar;87(3):221-7. doi: 10.1902/jop.2015.150386. Epub 2015 Oct 15.

Results Reference

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The Use of Mucograft® to Treat Gingival Recession

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