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.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- Complete root coverage
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Masking Description
A connective tissue graft will be harvested from the palate as a free gingival graft, which will be de-epithelialized with a 15-c blade(Zucchelli et al. 2010) before opening of the opaque envelopes, which contains the allocation concealment. Afterwards, test or control procedure will be carried out.
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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)
Investigators
Jerian González-Febles
Principal investigator
Universidad Complutense de Madrid