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Clinical Trials/NCT05122468
NCT05122468
Completed
N/A

The Use of a Connective Tissue Auto-graft in Combination With Either the Tunnel Technique or the Coronally Advanced Flap for the Treatment of Multiple Gingival Recession Defects. A Randomized Controlled Clinical Trial.

Universidad Complutense de Madrid1 site in 1 country30 target enrollmentDecember 2, 2016

Overview

Phase
N/A
Intervention
Not specified
Conditions
Gingival Recession
Sponsor
Universidad Complutense de Madrid
Enrollment
30
Locations
1
Primary Endpoint
Complete root coverage
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

Many studies have compared the tunnel technique and coronally advanced flap in the treatment of single and multiple recessions. However, there is a lack of evidence that compared both techniques in combination with a connective tissue graft, for just multiple adjacent recessions. No technique is clearly superior to another in terms of complete root coverage (CRC), mean root coverage (MRC) and the gain of keratinized tissue height (KTH) when multiple recession coverage was evaluated. Moreover, as a connective tissue graft supposed to offer more stability in terms of complete root coverage in long-term basis, the main question should be aimed at the role of the sub-epithelial connective tissue graft, when it is used in combination with one technique or another. Hence, the hypothesis is focused on if the use of a connective tissue graft in combination with a tunnel technique would provide higher clinical outcomes and similar patient-based outcomes than its use in combination with the Coronally Advanced flap technique.

Detailed Description

Parallel group, clinical evaluator- and statistician-blinded, randomized clinical trial.

Registry
clinicaltrials.gov
Start Date
December 2, 2016
End Date
May 25, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jerian González-Febles

Principal investigator

Universidad Complutense de Madrid

Eligibility Criteria

Inclusion Criteria

  • Subjects with a minimum of two adjacent teeth and a maximum of four adjacent teeth with gingival recessions (at least one with a depth ≥ 3 mm) and requiring surgical intervention, without medical contraindications to elective surgery.

Exclusion Criteria

  • Presence of untreated periodontitis
  • Persistence of uncorrected gingival trauma from tooth brushing
  • Interdental attachment loss greater than 1 mm or furcation involvement in the teeth to be treated
  • Presence of severe tooth malposition, rotation or clinically significant super-eruption
  • Self-reported current smoking
  • Presence of medical contraindications to elective surgery

Outcomes

Primary Outcomes

Complete root coverage

Time Frame: 6 months

The complete root coverage is defined as the percentage of cases that 100% of the recessions will be covered in their whole extension.

Secondary Outcomes

  • Clinical attachment Gain(6 months)
  • Wound Healing Index (WHI)(3 months)
  • Mean Root Coverage(6 months)
  • Probing pocket depth (PPD)(6 months)
  • Recession Reduction (RR)(6 months)
  • Width of Keratinized Tissue (KTW)(6 months)
  • Root Coverage Aesthetic Score (Ref)(6 months)

Study Sites (1)

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