The Use of Mucograft® to Treat Gingival Recession

NCT ID: NCT02986191

Last Updated: 2018-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2017-12-20

Brief Summary

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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

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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.

Conditions

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Gingival Recession

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Mucograft

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

Group Type EXPERIMENTAL

Mucograft

Intervention Type PROCEDURE

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

Connective tissue graft

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

Group Type ACTIVE_COMPARATOR

Connective Tissue Graft

Intervention Type PROCEDURE

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

Interventions

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Mucograft

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

Intervention Type PROCEDURE

Connective Tissue Graft

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Damascus University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Haydar Barakat, DDS MSc

Role: PRINCIPAL_INVESTIGATOR

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

Suleiman Dayoub, DDS MSc PhD

Role: STUDY_DIRECTOR

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

Locations

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Department of Periodontics, University of Damascus Dental School

Damascus, , Syria

Site Status

Countries

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Syria

References

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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.

Reference Type BACKGROUND
PMID: 20417009 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21837302 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22254233 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21721988 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23050490 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24597764 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26469812 (View on PubMed)

Other Identifiers

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UDDS-Perio-01-2016

Identifier Type: -

Identifier Source: org_study_id

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