Clinical trial NCT06135662: Comparing Tunnel Technique and CAF With CTG in Mandibular Gingival Recession Treatment
Official title: Tunnel Technique Versus Coronally Advanced Flap Combined With a Connective Tissue Graft for the Treatment of Mandibular Gingival Recessions: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gingival Recession Localized Moderate
Keywords: RT1
RT2
CAF
Tunnel Technique
Connective Tissue Graft
Gingival Recessions
CTG
Lead sponsor: Universitat Internacional de Catalunya
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to evaluate the effectiveness of two different surgical techniques, the Coronally Advanced Flap (CAF) and the Tunnel Technique (TT) with Connective Tissue Grafts (CTG), in treating mandibular gingival recession. This study, focusing on healthy patients with RT1 and RT2 gingival recessions, aims to determine which surgical approach offers better root coverage for mandibular recession defects. Additionally, it seeks to understand the effects of these techniques on aspects such as keratinized tissue gain, vestibular depth, gingival thickness, and patient-reported outcomes. Participants in this trial will undergo one of the two surgical procedures and are expected to attend a total of six assessment visits. Researchers will compare the results from both groups, those treated with CAF and those with TT+CTG, to discern if one method is superior in achieving more effective root coverage, enhanced aesthetic appearance, and reduced discomfort associated with gingival recession.

Detailed description: This clinical trial is designed to rigorously assess the effectiveness of two surgical techniques, the Coronally Advanced Flap (CAF) and the Tunnel Technique (TT) with Connective Tissue Grafts (CTG), in the treatment of mandibular gingival recession, specifically targeting RT1 and RT2 types of recessions. The primary objective of this study is to determine which of these approaches provides superior root coverage in managing mandibular recession defects. The secondary objectives include evaluating the impact of these treatments on keratinized tissue gain, changes in vestibular depth, variations in gingival thickness, and patient-reported outcomes such as pain and aesthetic satisfaction.

Healthy participants diagnosed with mandibular gingival recession will be enrolled and randomly assigned to undergo either the CAF or TT+CTG surgical procedure. The study will follow a structured timeline with a total of six assessment visits for each participant, scheduled at key intervals: 1 week, 2 weeks, 6 weeks, 3 months, and 6 months post-operation. These time points are chosen to effectively monitor both the immediate and the long-term results of the treatments.

The primary outcome measure, Mean Root Coverage (MRC), will be evaluated at each follow-up visit to quantify the extent of root coverage achieved by the respective surgical techniques. Secondary outcome measures include the assessment of Vestibular Depth (VD), Complete Root Coverage (CRC), changes in Keratinized Tissue Width (KT), and changes in Gingival Thickness (GT). These measures will provide a comprehensive understanding of the physiological and aesthetic impacts of the surgical interventions.

By comparing the outcomes from both treatment groups, the study aims to provide clear evidence on the effectiveness of CAF versus TT+CTG in treating mandibular gingival recession, guiding future clinical decisions and patient care strategies in periodontology.

Eligibility criteria: Inclusion Criteria:

* ≥18 years; periodontally and systemically healthy
* presence of RT1 and RT2 gingival recession defects
* recession in the mandibular arch
* recession ≥ 2mm in depth at the buccal aspect
* full-mouth plaque and bleeding score ≤ 20%
* no previous periodontal surgery
* presence of identifiable cemento-enamel junction (CEJ) (a step ≤1mm at the CEJ and/or presence of root abrasion, but with identifiable CEJ, will be accepted).

Exclusion Criteria:

* smokers ≥10 cigarettes a day
* contraindications for periodontal surgery
* medications known to affect the gingiva or interfere with wound healing
* pregnancy
* active orthodontic therapy
* caries or restorations in the area to be treated

Primary outcomes:
measure: Mean Root Coverage (MRC)
timeFrame: At 1 week, 2 weeks, 6 weeks, 3 months, and 6 months post-operation
Secondary outcomes:
measure: Vestibular depth (VD)
timeFrame: At 1 week, 2 weeks, 6 weeks, 3 months, and 6 months post-operation
measure: Complete Root Coverage (CRC)
timeFrame: At 1 week, 2 weeks, 6 weeks, 3 months, and 6 months post-operation
measure: change in Keratinized Tissue Width (KT)
timeFrame: At 1 week, 2 weeks, 6 weeks, 3 months, and 6 months post-operation
measure: change in gingival thickness (GT)
timeFrame: At 1 week, 2 weeks, 6 weeks, 3 months, and 6 months post-operation
Other outcomes:
Locations:
city: Sant Cugat del Vallès
country: Spain
facility: UIC Barcelona - Clinica Universitaria de Odontologia
state: Barcelona
Study officials:
affiliation: UIC Barcelona
name: Gonzalo Blasi, DDS MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zucchelli G, De Sanctis M. Treatment of multiple recession-type defects in patients with esthetic demands. J Periodontol. 2000 Sep;71(9):1506-14. doi: 10.1902/jop.2000.71.9.1506.
citation: Cairo F, Nieri M, Cattabriga M, Cortellini P, De Paoli S, De Sanctis M, Fonzar A, Francetti L, Merli M, Rasperini G, Silvestri M, Trombelli L, Zucchelli G, Pini-Prato GP. Root coverage esthetic score after treatment of gingival recession: an interrater agreement multicenter study. J Periodontol. 2010 Dec;81(12):1752-8. doi: 10.1902/jop.2010.100278. Epub 2010 Jul 14.