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

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ClinicalTrials.gov Identifier: NCT02774967
Recruitment Status : Completed
First Posted : May 17, 2016
Last Update Posted : May 20, 2016
Sponsor:
Information provided by (Responsible Party):
Arthur Belem Novaes Jr, University of Sao Paulo

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : March 2014
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

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,




Primary Outcome Measures :
  1. Comparing changes for Root coverage measure (in millimeter) from baseline at 6 months [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02774967


Locations
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Brazil
Gabriel F Bastos
Ribeirão Preto, SP, Brazil, 14098561
Sponsors and Collaborators
University of Sao Paulo
Investigators
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Principal Investigator: arthur b novaes jr, PhD FORP-USP
Principal Investigator: gabriel f bastos, MSD Student FORP-USP

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Responsible Party: Arthur Belem Novaes Jr, professor of periodontics department, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02774967     History of Changes
Other Study ID Numbers: 35907314.8.0000.5419
First Posted: May 17, 2016    Key Record Dates
Last Update Posted: May 20, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Arthur Belem Novaes Jr, University of Sao Paulo:
root coverage
gingival recession
periodontal surgery

Additional relevant MeSH terms:
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Atrophy
Periodontal Diseases
Gingival Recession
Mouth Diseases
Gingival Diseases
Stomatognathic Diseases
Periodontal Atrophy
Pathological Conditions, Anatomical