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

NCT02774967 | Completed

• 1 other identifier: 35907314.8.0000.5419
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

root coverage; gingival recession; periodontal surgery

Outcome Measures

Primary Outcomes (1)

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

  6 months

Study Arms (2)

extended flap technique

ACTIVE COMPARATOR

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

tunnel technique

EXPERIMENTAL

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

Interventions

root coverage PROCEDURE

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

extended flap technique; tunnel technique

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• diabetics pregnant women chronic use of medication periodontitis smokings

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Gabriel F Bastos

Ribeirão Preto, São Paulo, 14098561, Brazil

Location

MeSH Terms

Conditions

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

Study Officials

• arthur b novaes jr, PhD

  FORP-USP

  PRINCIPAL INVESTIGATOR

• gabriel f bastos, MSD Student

  FORP-USP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor of periodontics department

Study Record Dates

• First Submitted: May 13, 2016
• First Posted: May 17, 2016
• Study Start: March 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: May 20, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)