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CompletedNCT02774967Updated May 20, 2016

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

An interventional study of root coverage in Gingival Recession, Gingival Diseases and Mouth Diseases, sponsored by University of Sao Paulo. Completed at 1 site in Brazil. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2016-05-20.

Sponsored by University of Sao Paulo · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study 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.

02

Conditions studied

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

Keywords

  • root coverage
  • gingival recession
  • periodontal surgery
03

In context

Periodontal Diseases

830 studies on the registry are indexed under Periodontal Diseases; 188 are open to participants now.

This study's enrollment of 20 is below the median of 45 across 530 interventional studies indexed under Periodontal Diseases.

Browse Periodontal Diseases studies →

Lead sponsor

University of Sao Paulo is the lead sponsor of 1,005 studies on the registry; 90 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

diabetics pregnant women chronic use of medication periodontitis smokings

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Double (Investigator, Outcomes assessor)
Enrollment
20 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • Procedureroot coverage

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

06

What researchers measure

Primary outcomes

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

    Time frame: 6 months

07

Study locations

1 site
  • Gabriel F Bastos
    Ribeirão Preto, SP 14098561, Brazil
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 20, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02774967
Lead sponsor
University of Sao Paulo
Responsible party
Arthur Belem Novaes Jr (professor of periodontics department, University of Sao Paulo) — Principal investigator
First posted
May 17, 2016
Start date
Mar 2014
Primary completion
Jan 2016
Completion
Jan 2016
Last update
May 20, 2016

Study contacts

arthur b novaes jr, PhD
principal investigator · FORP-USP
gabriel f bastos, MSD Student
principal investigator · FORP-USP

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.

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