CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 30 enrolled
Drug / intervention
Connective tissue Harvest and CAF +1 moreprocedure
Likely dose
Not stated in record
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Search/NCT05122468
NCT05122468N/ACompleted

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 Madrid·interventional·Posted Nov 16, 2021·Updated Nov 4, 2022

In Brief

A clinical study evaluating Connective tissue Harvest and CAF and Connective tissue Harvest and Tunnel for Gingival Recession. Completed, enrolled 30 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSpain
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedNov 16, 2021
Enrollment StartDec 2, 2016
Primary CompletionMay 25, 2022
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 4.6 years ago

Interventions

Connective tissue Harvest and CAFprocedure

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. The dimensions of the graft achieve 3 to 5 mm mesial and distal from the lateral teeth with an ideal thickness about 1 to 1.5 mm. Donor tissue will be taken at premolar and molar level. In control sites, the graft will be adapted to cover each exposed root to the CEJ, and stabilized with either 6-0 resorbable sutures (with the knot placed under the papillary area) or a non-resorbable suture with the knot on the palatal side. For suturing of the graft, interrupted sutures or sling sutures (anchored to periosteum apical to the graft and hanging around the neck of the experimental teeth) may be used.

Connective tissue Harvest and Tunnelprocedure

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. The dimensions of the graft achieve 3 to 5 mm mesial and distal from the lateral teeth with an ideal thickness about 1 to 1.5 mm. Donor tissue will be taken at premolar and molar level. In test sites, the graft should be slid through the tunnel. To accomplish the adequate position of the graft into the tunnel, 2 sutures are first placed, 1 at the most mesial and the other at the most distal aspect of the tunnel. The needles should pass underneath the tunnel and exit through the largest or most central gingival recession, the one through which the grafting tissue will be introduced. With these 2 sutures already inside the tunnel, the graft is bitten on both ends with vertical mattress sutures.