Optimizing Clinical Outcomes in CAF + SCTG: the Impact of Compressive Sutures

Not Applicable

Not yet recruiting

• Conditions: Gingival Recessions; Gingival Recession, Mucogingival Surgery; Suture

• Registration Number: NCT06701786
• Lead Sponsor: G. d'Annunzio University

Brief Summary

This randomized controlled clinical trial aims to evaluate the additional effect on clinical outcomes of compressive sutures associated with coronally advanced flap (CAF) and subepithelial connective tissue graft (SCTG) for the treatment of RT1 gingival recessions (as classified by Cairo et al.).

Forty patients presenting with at least one RT1 recession will be enrolled in the study. Twenty participants will undergo CAF + SCTG with compressive sutures while the other 20 participants will receive the same procedure without compressive sutures. The primary outcome, complete root coverage (CRC), will be assessed six months after treatment.

Additional clinical parameters, including gingival recession (GR), clinical attachment level (CAL), pocket depth (PD), keratinized tissue width (KT), keratinized tissue thickness (GT), and Root Coverage Esthetic Score (RES), will be evaluated at baseline and at the six-month follow-up.

Patient-reported outcomes (PROs) will also be measured, including the degree of general discomfort (D) experienced, assessed on a Visual Analog Scale (VAS) from 0 to 10, as well as patient-reported aesthetic satisfaction (PRES) and overall treatment satisfaction (OTS), both quantified on a VAS scale from 0 to 10.

Detailed Description

The study will be a prospective, randomized, and controlled clinical trial designed to evaluate the added benefit of compressive sutures (2 orizzontal and 1 vertical sutures) on CAF + SCTG to treat RT1 gingival recessions. For each study patient, one RT1 recession will be included. Clinical parameters will be evaluated at baseline and six months after treatment.

Forty patients under care at the Periodontology Unit of the University of Chieti-Pescara, Italy, and presenting RT1 recessions, will be selected for inclusion.

All 40 patients will first undergo professional supragingival scaling using ultrasonic instruments. Patients will also receive motivational oral hygiene instructions to adopt proper, pressure-free brushing techniques and non-traumatic use of dental floss and/or interdental brushes. The use of a pressure-controlled electric toothbrush with an extra-soft head will be recommended, and detailed instructions for its use will be provided. Access to the surgical phase will only be permitted after the achievement of supragingival plaque control through these non-traumatic oral hygiene procedures.

A computer-generated, customized randomization table will be used to allocate experimental units into the two study groups.

Post-surgical care will include a regimen of 2 g/day of amoxicillin combined with clavulanic acid for six days and oral ibuprofen 600 mg as needed for pain control. Sutures will be removed two weeks after surgery. Plaque control of the grafted area will be managed for three weeks post-surgery with a twice-daily rinse using a 0.12% chlorhexidine digluconate solution. Additionally, patients will apply a 1% chlorhexidine gel twice daily. Patients will undergo weekly professional supragingival cleaning and motivational reinforcement sessions for six weeks. Gentle cleaning with a soft toothbrush and interdental cleaning will be allowed starting two weeks after suture removal. All measurements will be performed by a single experienced operator. Complete root coverage (CRC) will be assumed as the main outcome at 6 months after treatment. Gingival recession (GR), clinical attachment level (CAL), pocket depth (PD), keratinized tissue width (KT,) thickness of keratinized tissue (GT), Root coverage esthetic score will be assessed at baseline and 6 months after treatment. PROMs will also be evaluated. The degree of general discomfort (D) experienced will be assessed on a VAS scale (0-10). Patient-reported aesthetic satisfaction (PRES) at T1 will also be quantified on a VAS scale (0-10). Overall treatment satisfaction (OTS) at T1 will be assessed by asking each patient if they would undergo surgery again (yes/no).

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-19
• Study First Submitted QC: 2024-11-19
• Last Update Submitted: 2024-11-19
• Study First Posted: 2024-11-22
• Last Update Posted: 2024-11-22
• Study Start: 2024-12-01
• Primary Completion: 2025-05-31
• Study Completion: 2025-11-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• systemic factors (no systemic diseases; no coagulation disorders; no medications affecting periodontal status in the previous 6 months; no pregnancy or lactation
• never smokers/former smokers >=10years
• a full-mouth plaque score (FMPS)and a full-mouth bleeding score (FMBS) lower than 15%
• no periodontal surgery on the experimental sites
• >= 20 teeth without mobility
• no presence of cervical carious lesions or periapical lesions at experimental sites
• at least one RT1 buccal gingival recession

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Exclusion Criteria

• systemic diseases
• coagulation disorders
• medications affecting periodontal status in the previous 6 months
• pregnancy or lactation
• Smokers

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Complete root coverage	6 months	Percentage of experimental sites that achieved complete root surface coverage.

Secondary Outcome Measures

Name	Time	Method
Gingival Recession	6 months	Distance from cementoenamel junction and gingival margin
Gingival thickness	6 months	Gingival tissue thickness evaluated 2 mm apical to the recession
Keratinized tissue width	6 months	Distance between gingival margin and Mucogingival Junction
Clinical attachment level	6 months	Distance between cementoenamel junction(CEJ) and depth of the pocket
Pocket depth	6 months	Distance between gingival margin and bottom of the pocket
Discomfort	4 weeks	Evaluation of post-operative discomfort using Visual Analogue Scale (VAS).The scale is represented by a straight horizontal line of fixed length, generally 10 cm. Extremities are defined as extreme limits of the parameter to be measured, oriented from left (worst) to right (best).
Patient-Reported Esthetic Satisfaction	6 months	Patient-reported esthetic satisfaction (PRES) quantified on a VAS scale (0-10), will be recorded after observing simultaneously 2 standardized photographs showing the treated site +2 mesial and 2 distal teeth and the MGJ
Root Coverage Esthetic Score	6 months	This score evaluates five variables: level of the gingival margin, marginal tissue contour, soft tissue texture, mucogingival junction alignment, and gingival color.

Trial Locations

Locations (1)

Department of Innovative Technologies in Medicine and Dentistry, Chieti,; 🇮🇹 Chieti, Italy