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Completed

NCT Number: NCT03675334

Mucoderm or Connective Tissue Graft for Treatment of Gingival Recessions

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).

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Key information

Conditions

Gingival Recession Gingival Diseases Mouth Diseases Periodontal Atrophy Periodontal Diseases Stomatognathic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Dentistry of Ribeirao Preto - University of Sao Paulo

Ribeirão Preto, São Paulo, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Root coverage with collagen matrix graft

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.

Root coverage with subepithelial connective tissue graft

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

Other

profilaxis, coronary polishing and scaling and root planning

Primary outcomes

  1. Root coverage after 6 months

    Time frame: 6 months

    Root coverage is measured by the difference between the gingival recession height at 6 months and baseline

Secondary outcomes

  1. Keratinized tissue gain after 6 months

    Time frame: 6months

    The difference between keratinized tissue width and depth at 6 months and at baseline

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

Clinical Comparison Between the Use of a Connective Tissue Graft or a Porcine Collagen Matrix (Mucoderm) for Treatment of Gingival Recessions Type 1: a Randomized Controlled Clinical Study.

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Sep 18, 2018
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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