Tunnel vs. CAF for the Treatment of Multiple Gingival Recessions

Not Applicable

Completed

• Conditions: Gingival Recession
• Interventions: Procedure: Connective tissue Harvest and Tunnel; Procedure: Connective tissue Harvest and CAF

• Registration Number: NCT05122468
• Lead Sponsor: Universidad Complutense de Madrid

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 Timeline

• Study Start: 2016-12-02
• Study First Submitted: 2021-05-03
• Study First Submitted QC: 2021-11-04
• Study First Posted: 2021-11-16
• Primary Completion: 2022-05-25
• Study Completion: 2022-05-25
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-03
• Last Update Posted: 2022-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tunnel group	Connective tissue Harvest and Tunnel	Tunnel technique in combination with a connective tissue graft. When tunnelling procedures are applied, this technique consists of a supra-periosteal bed under a pedicle flap without any external incisions (Zabalegui et al. 1999). Afterwards, a connective tissue graft is placed and secured through the tunnel, covering the adjacent exposed roots. To create a tunnel at the buccal aspect of the gingiva, sulcular partial-thickness incisions are made by means of a micro-blade through each recession area, extending the split-thickness beyond the mucogingival junction (MGJ). The partial dissection plane is then extended laterally through the papillae between the treated teeth without separating them. This incision must also be extended 3 to 5 mm mesial and distal from the lateral teeth to allow space for the connective tissue graft.
CAF group	Connective tissue Harvest and CAF	Coronally advanced flap in combination with a connective tissue graft. According to the technique(Zucchelli \& De Sanctis 2000), this procedure consists of a rotated papilla, envelope flap. Intrasulcular incisions will be performed involving all the experimental units and at least one tooth mesial and distal to the experimental teeth. From the centre of rotation the incisions will be traced in a corono-apical direction toward the mesial and toward the distal extension of the flap. After the accurate initial incisions, the flap will be raised full thickness apical to the mucogingival junction (MGJ), exposing 1 to 2 mm of bone at the base of the recession/dehiscence defects. A linear mesio-distal incision will then be performed to cut the periosteum, releasing any muscular tension and allow a passive coronal positioning of the flap to cover the CEJ.

Primary Outcome Measures

Name	Time	Method
Complete root coverage	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 Outcome Measures

Name	Time	Method
Clinical attachment Gain	6 months	It is the change in clinical attachment levels between baseline and 6 Months post-opeartive. Clinical attachment level is defined as the sum of recession and probing pocket depth.
Wound Healing Index (WHI)	3 months	Early wound healing will be assessed semi-quantitatively with a composite index (Dastoor et al. 2007)designed to explore 4 areas/aspects of wound healing: i) the flap margin; ii) the interdental papilla; iii) the graft; and iv) the sutures. Weighted scores will be given to each parameter to develop a score designed to have a low value in a situation of perfect/uneventful early wound healing and higher values when aspects of wound failure will be detected
Mean Root Coverage	6 months	The mean root coverage is the percentage of recession extension, which will be covered at 6 months after surgery.
Probing pocket depth (PPD)	6 months	Depth of the gingival sulcus/pocket will be assessed on the mid-facial aspect of each tooth. The width of keratinized tissue will be assessed clinically, while attached gingival will be derived mathematically subtracting the width of keratinized gingiva and the depth of the sulcus/pocket.
Recession Reduction (RR)	6 months	It is described as the changes in recession measurements between baseline and 6 months post-operative. Recession is defined as position of the gingival margin. All included recessions will be measured with two methods: 1. from the CEJ to the gingival margin; 2. from the incisal edge to the gingival margin All measures will be taken using as reference the most apical position of the gingival margin on the facial aspect of the tooth.
Width of Keratinized Tissue (KTW)	6 months	It is measured as the distance from the free gingival margin to the mucogingival junction, which will be measured at 6 months.
Root Coverage Aesthetic Score (Ref)	6 months	In order to assess the aesthetic outcome achieved after root coverage procedures, the Root Coverage Esthetic Score index (Cairo et al. 2009)will be used. This system evaluated 5 variables 6 months after the surgical procedure. The position of the gingival margin received 0, 3 or 6 points while all the other variables (marginal tissue contour, soft tissue texture, gingival color and MGJ alignment) were assigned either 0 or 1.

Trial Locations

Locations (1)

Universidad Complutense de Madrid; 🇪🇸 Madrid, Spain