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

NCT ID: NCT02774967

Last Updated: 2016-05-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2016-01-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

root coverage

Intervention Type: PROCEDURE

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

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

Group Type: EXPERIMENTAL

root coverage

Intervention Type: PROCEDURE

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

Interventions

root coverage

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Arthur Belem Novaes Jr

professor of periodontics department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

arthur b novaes jr, PhD

Role: PRINCIPAL_INVESTIGATOR

FORP-USP

gabriel f bastos, MSD Student

Role: PRINCIPAL_INVESTIGATOR

FORP-USP

Locations

Gabriel F Bastos

Ribeirão Preto, São Paulo, Brazil

Countries

Brazil

Other Identifiers

35907314.8.0000.5419

Identifier Type: -

Identifier Source: org_study_id