Comparing Tunnel Technique and CAF With CTG in Mandibular Gingival Recession Treatment

NCT ID: NCT06135662

Last Updated: 2024-03-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-11
• Study Completion Date: 2025-06-10

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.

Conditions

Gingival Recession Localized Moderate

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

CAF + CTG

This arm involves patients treated with the Coronally Advanced Flap (CAF) technique, a recognized method for treating gingival recession. As an active comparator, this arm serves to compare the effectiveness and outcomes of CAF against the alternative surgical method used in the study.

Group Type: ACTIVE_COMPARATOR

CAF + CTG

Intervention Type: PROCEDURE

Surgical techniques for mandibular gingival recession: coronally advanced flap + connective tissue graft. Participants undergo initial evaluations, including periodontal exams and digital imaging, followed by standardized pre-operative preparations. Post-surgery, uniform care includes pain management and oral hygiene instructions, with follow-ups to monitor healing and assess outcomes. Primary and secondary outcomes, like root coverage and patient-reported satisfaction, are consistently measured across groups. Standardized data collection and analysis procedures ensure reliable, comparable results, facilitating an effective comparison of the surgical methods' efficacy.

Tunnel Technique + CTG

Patients in this arm receive the Tunnel Technique (TT) with Connective Tissue Grafts (CTG). Also an established method for gingival recession treatment, this arm acts as an active comparator to assess and compare the effectiveness of TT+CTG against the CAF technique.

Group Type: ACTIVE_COMPARATOR

Tunnel Technique + CTG

Intervention Type: PROCEDURE

Surgical techniques for mandibular gingival recession: tunnel technique + connective tissue graft. Participants undergo initial evaluations, including periodontal exams and digital imaging, followed by standardized pre-operative preparations. Post-surgery, uniform care includes pain management and oral hygiene instructions, with follow-ups to monitor healing and assess outcomes. Primary and secondary outcomes, like root coverage and patient-reported satisfaction, are consistently measured across groups. Standardized data collection and analysis procedures ensure reliable, comparable results, facilitating an effective comparison of the surgical methods' efficacy.

Interventions

CAF + CTG

Surgical techniques for mandibular gingival recession: coronally advanced flap + connective tissue graft. Participants undergo initial evaluations, including periodontal exams and digital imaging, followed by standardized pre-operative preparations. Post-surgery, uniform care includes pain management and oral hygiene instructions, with follow-ups to monitor healing and assess outcomes. Primary and secondary outcomes, like root coverage and patient-reported satisfaction, are consistently measured across groups. Standardized data collection and analysis procedures ensure reliable, comparable results, facilitating an effective comparison of the surgical methods' efficacy.

Intervention Type: PROCEDURE

Tunnel Technique + CTG

Surgical techniques for mandibular gingival recession: tunnel technique + connective tissue graft. Participants undergo initial evaluations, including periodontal exams and digital imaging, followed by standardized pre-operative preparations. Post-surgery, uniform care includes pain management and oral hygiene instructions, with follow-ups to monitor healing and assess outcomes. Primary and secondary outcomes, like root coverage and patient-reported satisfaction, are consistently measured across groups. Standardized data collection and analysis procedures ensure reliable, comparable results, facilitating an effective comparison of the surgical methods' efficacy.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universitat Internacional de Catalunya

OTHER

Sponsor Role: lead

Responsible Party

Gonzalo Blasi

Clinical Head Staff

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gonzalo Blasi, DDS MS

Role: PRINCIPAL_INVESTIGATOR

UIC Barcelona

Locations

UIC Barcelona - Clinica Universitaria de Odontologia

Sant Cugat del Vallès, Barcelona, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Gonzalo Blasi, DDS MS

Role: CONTACT

gonzaloblasi@uic.es

+34 620387688

Facility Contacts

UIC Universidad Internacional de Catalunya

Role: primary

clinica@uic.es

935042030

References

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.

Reference Type: BACKGROUND

PMID: 11022782 (View on PubMed)

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.

Reference Type: RESULT

PMID: 20629546 (View on PubMed)

Other Identifiers

PER-ECL-2023-01

Identifier Type: -

Identifier Source: org_study_id