Comparation Between Two Surgical Techniques With Acellular Dermal Matrix in Treatment of Gingival Recessions

Periodontal Diseases Clinical Trial

Official title:

Comparation Between Two Surgical Techniques With Acellular Dermal Matrix in Treatment of Gingival Recessions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02774967
• Other study ID #: 35907314.8.0000.5419
• Status: Completed
• Phase: N/A
• First received: May 13, 2016
• Last updated: May 19, 2016
• Start date: March 2014
• Est. completion date: January 2016

Study information

• Verified date: May 2016
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The gold standard for the treatment of gingival recession, is the coronal repositioning of the flap associated with the subepithelial connective tissue graft. The acellular dermal matrix (ADM) has been used as a substitute a subepithelial connective tissue graft in periodontal plastic surgery and mucogengivais, and has achieved similar results. The use of ADM has the advantage of avoiding possible pre and postoperative complications, as well as overcome the limitations presented by autograft. The different surgical techniques used for root coverage seek predictability and success. For this, besides the type of incision placements flap and graft are of utmost importance because the healing benefit and outcome.

The aim of this study is to compare two surgical techniques for root coverage and evaluate which one provides better cosmetic results and less morbidity . 20 adults , nonsmoking patients , showing multiple bilateral gingival recessions , class I or II Miller located in canine, first and second premolars are selected. Both techniques use the ADM as a graft. However , in one Quadrant partial flap will be held together with relaxing incisions through an incision intrasucular , ADM will be positioned 1 mm apical to the cementoenamel junction (CEJ) and the flap will be positioned 1 mm coronal CEJ. In the opposite quadrant a minimally invasive technique periosteal envelope above does not use relaxing incisions , preserves the buds will be held , as well as avoiding any scars, the graft will be used to ADM. The clinical parameters (probing depth, clinical attachment level, bleeding on probing index, height and width of the gingival retraction and height and thickness of keratinized gingiva) will be evaluated 2 weeks after the basic periodontal therapy and after 6 and 12 months to surgical procedures. In addition, measurements of photographic gingival recession with the aid of software will be performed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

ages 18 to 50 years old bilateral multiple gingival recession type Miller class I or II with at least one tooth with 3 mm in height and less than 3mm of keratinized tissue in canine and pre-molar teeth

Exclusion Criteria:

diabetics pregnant women chronic use of medication periodontitis smokings

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Procedure:
• root coverage
Root coverage with acellular dermal matrix using two techniques: advanced positional flap ou tunneling,

Locations

Country	Name	City	State
Brazil	Gabriel F Bastos	Ribeirão Preto	SP

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	Comparing changes for Root coverage measure (in millimeter) from baseline at 6 months		6 months	No