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

NCT ID: NCT06701786

Last Updated: 2024-11-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-01
• Study Completion Date: 2025-11-30

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).

Conditions

Gingival Recessions; Gingival Recession, Mucogingival Surgery; Suture

Study Design

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

Study Groups

CAF+SCTG+ Compressive Suture

A tension-free trapezoidal flap will be elevated by the split-full-split technique. A 1-mm thick SCTG will be harvested from the palate as epithelialized graft. After epithelium removal, the graft was positioned and sutured 1mm apical to the cement-enamel junction with 5-0 resorbable sutures . The SCTG will then be covered by the tension-free coronally positioned flap by 5-0 silk sutures.After flap repositioning, two horizontal cross-mattress compressive sutures and one vertical cross-mattress compressive suture will be placed. All compressive sutures will be performed using 2.0 silk suture.

Group Type: EXPERIMENTAL

Compressive Sutures (CSs) group

Intervention Type: PROCEDURE

The extent of the depth of the recession will be reported on the anatomical papillae and, after adding 1mm, 2 horizontal incisions of approximately 3mm will be made at the base of the surgical papillae laterally to the recession.Two divergent releasing incisions will be made extending approximately 2-3mm into the alveolar mucosa.The surgical papillae will be detached in partial thickness. A full thickness dissection will be performed from the bottom of the recession to expose approximately 3mm of the crest bone.A partial thickness dissection will be performed in the most apical portion of the flap until complete passivation of the flap is obtained.The harvesting of the epithelial-connective graft will be performed . The de-epithelialised graft will be sutured at the level of the de-epithelialised anatomical papillae; then the flap will be repositioned coronally suturing the anatomical papillae on the surgical ones. Three compressive sutures will be placed on the repositioned flap.

CAF+ SCTG alone

A tension-free trapezoidal flap will be elevated by the split-full-split technique. A 1-mm thick SCTG will be harvested from the palate as epithelialized graft. After epithelium removal, the graft was positioned and sutured 1mm apical to the cement-enamel junction with 5-0 resorbable sutures . The SCTG will then be covered by the tension-free coronally positioned flap by 5-0 silk sutures. No compressive suture will be performed.

Group Type: ACTIVE_COMPARATOR

Without Compressive Sutures (WCSs) group

Intervention Type: PROCEDURE

The extent of the depth of the recession will be reported on the anatomical papillae and, after adding 1 mm, 2 horizontal incisions of approximately 3 mm will be made at the base of the surgical papillae laterally to the recession.Two divergent releasing incisions will be made extending approximately 2-3 mm into the alveolar mucosa.The surgical papillae will be detached in partial thickness. A full thickness dissection will be performed from the bottom of the recession to expose approximately 3mm of the crest bone.A partial thickness dissection will be performed in the most apical portion of the flap until complete passivation of the flap is obtained.The harvesting of the epithelial-connective graft will be performed. The de-epithelialised graft will be sutured at the level of the de-epithelialised anatomical papillae; than then the flap will be repositioned coronally suturing the anatomical papillae on the surgical ones.

Interventions

Compressive Sutures (CSs) group

The extent of the depth of the recession will be reported on the anatomical papillae and, after adding 1mm, 2 horizontal incisions of approximately 3mm will be made at the base of the surgical papillae laterally to the recession.Two divergent releasing incisions will be made extending approximately 2-3mm into the alveolar mucosa.The surgical papillae will be detached in partial thickness. A full thickness dissection will be performed from the bottom of the recession to expose approximately 3mm of the crest bone.A partial thickness dissection will be performed in the most apical portion of the flap until complete passivation of the flap is obtained.The harvesting of the epithelial-connective graft will be performed . The de-epithelialised graft will be sutured at the level of the de-epithelialised anatomical papillae; then the flap will be repositioned coronally suturing the anatomical papillae on the surgical ones. Three compressive sutures will be placed on the repositioned flap.

Intervention Type: PROCEDURE

Without Compressive Sutures (WCSs) group

The extent of the depth of the recession will be reported on the anatomical papillae and, after adding 1 mm, 2 horizontal incisions of approximately 3 mm will be made at the base of the surgical papillae laterally to the recession.Two divergent releasing incisions will be made extending approximately 2-3 mm into the alveolar mucosa.The surgical papillae will be detached in partial thickness. A full thickness dissection will be performed from the bottom of the recession to expose approximately 3mm of the crest bone.A partial thickness dissection will be performed in the most apical portion of the flap until complete passivation of the flap is obtained.The harvesting of the epithelial-connective graft will be performed. The de-epithelialised graft will be sutured at the level of the de-epithelialised anatomical papillae; than then the flap will be repositioned coronally suturing the anatomical papillae on the surgical ones.

Intervention Type: PROCEDURE

Eligibility Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

G. d'Annunzio University

OTHER

Sponsor Role: lead

Responsible Party

Michele Paolantonio

Full Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Innovative Technologies in Medicine and Dentistry, Chieti,

Chieti, Chieti, Italy

Countries

Italy

Central Contacts

Michele Paolantonio, MD, DDS

Role: CONTACT

michelepaolantonio@gmail.com

3395204073

Facility Contacts

Michele Paolantonio, MD DDS

Role: primary

michelepaolantonio@gmail.com

Michele Paolantonio, MD, DDS

Role: backup

Other Identifiers

201124

Identifier Type: -

Identifier Source: org_study_id