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Clinical Trials/NCT03619096
NCT03619096
Withdrawn
Not Applicable

Clinical Comparison Between Two Surgical Techniques for the Treatment of Multiple Gingival Recessions With Porcine Collagen Matrix

University of Sao Paulo2 sites in 1 country20 target enrollmentMarch 6, 2017

Overview

Phase
Not Applicable
Intervention
tunnel technique for Root coverage with Porcine collagen Matrix
Conditions
Gingival Recession
Sponsor
University of Sao Paulo
Enrollment
20
Locations
2
Primary Endpoint
Root coverage (milimeters)
Status
Withdrawn
Last Updated
17 days ago

Overview

Brief Summary

The gold standard for gingival recession treatment is the coronal repositioning of the flap associated with the subepithelial connective tissue graft. The porcine collagen matrix (PCR) has been used as a substitute for subepithelial connective tissue graft in periodontal plastic surgery and has achieved similar results. The PCR use 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 the most important because the healing benefits and outcome .

The aim of this study is to compare two surgical techniques for root coverage and evaluate which one provides better clinical outcomes 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 PCR as a graft . However, in one Quadrant partial flap will be held together with relaxing incisions through an intrasulcular incision, PCR 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 periosteal envelope that does not use relaxing incisions, avoiding any scars, will be performed with the PCR. The clinical parameters (gingival recession height and width, keratinized tissue thickness and width) will be evaluated 2 weeks after basic periodontal therapy and after 6 and 12 months to surgical procedures..

Registry
clinicaltrials.gov
Start Date
March 6, 2017
End Date
July 6, 2019
Last Updated
17 days ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Arthur Belem Novaes Jr

Teacher of Periodontia- Department of Buco Maxillofacial Surgery and Traumatology and Periodontics

University of Sao Paulo

Eligibility Criteria

Inclusion Criteria

  • bilateral multiple gingival recession type Miller class I or II with at least one tooth with 3 mm of gingival recession height

Exclusion Criteria

  • diabetics
  • pregnant women
  • chronic use of medication
  • periodontitis

Arms & Interventions

Test Group (tunnel technique)

It Will be performed root coverage of multiple recessions using porcine collagen matrix with a tunnel Technique

Intervention: tunnel technique for Root coverage with Porcine collagen Matrix

Control Group (extended flap technique)

It Will be performed root coverage of multiple recessions using porcine collagen matrix with a extended flap technique

Intervention: extended fla technique for Root coverage with Porcine collagen Matrix

Outcomes

Primary Outcomes

Root coverage (milimeters)

Time Frame: baseline, 6 and 12 motnhs

Root Coverage is measured by the difference between Gingival Recession Hight at baseline and 12 months

Change in gingival recession height (mm)

Time Frame: baseline, 6, and 12 months

Gingival recession height will be measured at baseline, 6 months, and 12 months. The primary outcome will be the change in gingival recession height from baseline to 12 months.

Secondary Outcomes

  • Keratinized tissue (milimeters)(baseline, 6 and 12 months)
  • Keratinized tissue width and thickness (mm)(baseline, 6, and 12 months)

Study Sites (2)

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