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

Sponsor

University of Sao Paulo (Other)

Overall Status

Completed

CT.gov ID

NCT02774967

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Gingival Recession Gingival Diseases Mouth Diseases Periodontal Atrophy Periodontal Diseases Stomatognathic Diseases	Procedure: root coverage	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2014

Actual Primary Completion Date :

Jan 1, 2016

Actual Study Completion Date :

Jan 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: extended flap technique root coverage comparing two techniques The aim of this study was to compare and show the benefits of the extended flap technique compared to Tunnel technique both techniques using the acellular dermal matrix for root coverage. Other Names: acellular dermal matrix extended flap technique	Procedure: root coverage Root coverage with acellular dermal matrix using two techniques: advanced positional flap ou tunneling,
Experimental: tunnel technique root coverage comparing two techniques The aim of this study was to compare and show the benefits of the extended flap technique compared to Tunnel technique both techniques using the acellular dermal matrix for root coverage. Other Names: acellular dermal matrix extended flap technique	Procedure: root coverage Root coverage with acellular dermal matrix using two techniques: advanced positional flap ou tunneling,

Arm

Intervention/Treatment

Active Comparator: extended flap technique

root coverage comparing two techniques The aim of this study was to compare and show the benefits of the extended flap technique compared to Tunnel technique both techniques using the acellular dermal matrix for root coverage. Other Names: acellular dermal matrix extended flap technique

Procedure: root coverage

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

Experimental: tunnel technique

Procedure: root coverage

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

Outcome Measures

Primary Outcome Measures

Comparing changes for Root coverage measure (in millimeter) from baseline at 6 months [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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