NCT02986191

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®.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 29, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 8, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2017

Completed
Last Updated

February 6, 2018

Status Verified

February 1, 2018

Enrollment Period

8 months

First QC Date

November 29, 2016

Last Update Submit

February 3, 2018

Conditions

Gingival Recession

Keywords

gingival graftfree gingival graftcoronally advanced flapreduced keratinized gingiva

Outcome Measures

Primary Outcomes (1)

  • 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.

    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 Outcomes (8)

  • Change in Probing Depth

    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

    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

    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

    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

    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

  • +3 more secondary outcomes

Study Arms (2)

Mucograft

EXPERIMENTAL

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

Procedure: Mucograft

Connective tissue graft

ACTIVE COMPARATOR

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

Procedure: Connective Tissue Graft

Interventions

MucograftPROCEDURE

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

Mucograft
Connective Tissue GraftPROCEDURE

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

Connective tissue graft

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Periodontics, University of Damascus Dental School

Damascus, DM20AM18, Syria

Location

Related Publications (7)

  • 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.

    PMID: 20417009BACKGROUND

  • 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.

    PMID: 21837302BACKGROUND

  • 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.

    PMID: 22254233BACKGROUND

  • 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.

    PMID: 21721988BACKGROUND

  • 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.

    PMID: 23050490BACKGROUND

  • 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.

    PMID: 24597764BACKGROUND

  • 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.

    PMID: 26469812BACKGROUND

MeSH Terms

Conditions

Gingival Recession

Interventions

Mucograft

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Study Officials

  • Haydar Barakat, DDS MSc

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

    PRINCIPAL INVESTIGATOR

  • Suleiman Dayoub, DDS MSc PhD

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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2016

First Posted

December 8, 2016

Study Start

August 1, 2016

Primary Completion

April 1, 2017

Study Completion

December 20, 2017

Last Updated

February 6, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations

SY(1)