Clinical Comparison Between Two Surgical Techniques for the Treatment of Gingival Recessions

Gingival Recession Clinical Trial

Official title:

Clinical Comparison Between Two Surgical Techniques With Acellular Dermal Matrix Graft in the Treatment of Gingival Recessions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01175720
• Other study ID #: lga030183
• Status: Completed
• Phase: N/A
• First received: August 3, 2010
• Last updated: November 11, 2011
• Start date: August 2010
• Est. completion date: October 2011

Study information

• Verified date: November 2011
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: University of Sao PauloBrazil: Faculty of Dentistry of Ribeirão Preto
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to test a surgical technique for the treatment of gingival recessions. The hypothesis of the study is to promote greater root coverage and better healing.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: October 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Recession defects are Miller's class I or II and do not vary more or equal than 3 mm

• Main complaint aesthetic issues or dentine hypersensitivity

• The patient must be a candidate for bilateral root coverage procedure

• Patient shows sufficient plaque control (FMPS < 20%)

• The patient is able to comply with the study-related procedures such as exercising good oral hygiene and attending all follow-up procedures

• The patient is able to fully understand the nature of the proposed surgery and is able to provide a signed informed consent

Exclusion Criteria:

• Smokers

• Systemic diseases

• Pregnants or lactating

• Periodontal disease

• General contraindications for dental and/or surgical treatment are present

• The patient has a history of malignancy, radiotherapy, or chemotherapy for malignancy within the past five years

• The patient is taking medications or having treatments which have an effect on mucosal healing in general (e.g. steroids, large doses of anti-inflammatory drugs)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gingival Recession

Intervention

Procedure:
• Periodontal surgery to gingival recessions
Test and control technique to treat gingival recessions.

Locations

Country	Name	City	State
Brazil	Faculty of Dentistry of Ribeirão Preto USP	Ribeirão Preto	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of root coverage	Clinical parameters will be assessed after 6 months of surgical procedures.	6 months	No
Secondary	Keratinized Tissue	Clinical parameters will be assessed after 6 months of surgical procedures.	6 months	No