Mucoderm or Connective Tissue Graft for Treatment of Gingival Recessions

Gingival Recession Clinical Trial

Official 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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03675334
• Other study ID #: CAAE 58534216.5.0000.5419
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 1, 2016
• Est. completion date: January 2019

Study information

• Verified date: September 2018
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 18
• Est. completion date: January 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Gingival Recession

Intervention

Procedure:
• 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.
• 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.

Other:
• Basic periodontal treatment
profilaxis, coronary polishing and scaling and root planning

Locations

Country	Name	City	State
Brazil	School of Dentistry of Ribeirao Preto - University of Sao Paulo	Ribeirão Preto	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Root coverage after 6 months	Root coverage is measured by the difference between the gingival recession height at 6 months and baseline	6 months
Secondary	Keratinized tissue gain after 6 months	The difference between keratinized tissue width and depth at 6 months and at baseline	6months