Mucoderm or Connective Tissue Graft for Treatment of Gingival Recessions

NCT ID: NCT03675334

Last Updated: 2018-09-18

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-01

Study Completion Date

2019-01-31

Brief Summary

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Coronally advanced flap plus connective tissue graft (CTG) is the gold standard therapy for root coverage. The bioabsorbable porcine collagen matrix (CM) has been widely used in periodontal and mucogingival surgery as a substitute for CTG and has achieved similar results. The CM has the advantage of no need of a second surgical area and availability overcoming the limitations of donor site in autograft.

The aim of this study is to investigate the use of Mucoderm® in root coverage procedures combined with extended coronally positioned flap (ECAF), test group (TG), in comparison to the connective tissue graft associated with the ECAF, control group (CG).

Detailed Description

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Conditions

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Gingival Recession

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Controlled Split-mouth clinical trial
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
The clinical parameters were screened by one single examiner that was not aware of the procedures

Study Groups

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Test Group

Active comparator: gingival recession

the aim of this study is to compare if the collagen matrix graft is as efficient as a substitute for the connective graft used in root coverage of gingival recessions

Group Type ACTIVE_COMPARATOR

Root coverage with collagen matrix graft

Intervention Type PROCEDURE

at one side, the root coverage have been done with a extended flap technique and collagen matrix graft. At the other side, the same technique was performed with connective graft.

Basic periodontal treatment

Intervention Type OTHER

profilaxis, coronary polishing and scaling and root planning

Control Group

the aim of this study is to compare if the collagen matrix graft is as efficient as a substitute for the connective graft used in root coverage of gingival recessions. The control group was treated with the same technique as the collagen matrix graft.

Group Type PLACEBO_COMPARATOR

Root coverage with subepithelial connective tissue graft

Intervention Type PROCEDURE

at one side, the root coverage have been done with a extended flap technique and collagen matrix graft. At the other side, the same technique was performed with connective graft.

Basic periodontal treatment

Intervention Type OTHER

profilaxis, coronary polishing and scaling and root planning

Interventions

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Root coverage with collagen matrix graft

at one side, the root coverage have been done with a extended flap technique and collagen matrix graft. At the other side, the same technique was performed with connective graft.

Intervention Type PROCEDURE

Root coverage with subepithelial connective tissue graft

at one side, the root coverage have been done with a extended flap technique and collagen matrix graft. At the other side, the same technique was performed with connective graft.

Intervention Type PROCEDURE

Basic periodontal treatment

profilaxis, coronary polishing and scaling and root planning

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* CEJ without significant damage;
* localized bilateral RT1 gingival recession ≥3 mm in the same arch

Exclusion Criteria

* previous periodontal surgical treatment on the involved sites;
* smokers
* pregnants or lactating
* compromised systemic health and contraindications for periodontal surgery
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Arthur Belem Novaes Jr

Phd, Ms, DDs. Chairman of Periodontolgy

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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School of Dentistry of Ribeirao Preto - University of Sao Paulo

Ribeirão Preto, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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Suzuki KT, de Jesus Hernandez Martinez C, Suemi MI, Palioto DB, Messora MR, de Souza SLS, Novaes AB Jr, Chaves Furlaneto FA, Taba M Jr. Root coverage using coronally advanced flap with porcine-derived acellular dermal matrix or subepithelial connective tissue graft: a randomized controlled clinical trial. Clin Oral Investig. 2020 Nov;24(11):4077-4087. doi: 10.1007/s00784-020-03280-x. Epub 2020 May 7.

Reference Type DERIVED
PMID: 32382931 (View on PubMed)

Other Identifiers

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CAAE 58534216.5.0000.5419

Identifier Type: -

Identifier Source: org_study_id

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