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

G

G. d'Annunzio University

Status

Not yet enrolling

Conditions

Gingival Recession, Mucogingival Surgery
Suture
Gingival Recessions

Treatments

Procedure: Compressive Sutures (CSs) group
Procedure: Without Compressive Sutures (WCSs) group

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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).

Enrollment

40 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

40 participants in 2 patient groups

CAF+SCTG+ Compressive Suture
Experimental group
Description:
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.
Treatment:
Procedure: Compressive Sutures (CSs) group
CAF+ SCTG alone
Active Comparator group
Description:
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.
Treatment:
Procedure: Without Compressive Sutures (WCSs) group

Trial contacts and locations

1

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Central trial contact

Michele Paolantonio, MD, DDS

Data sourced from clinicaltrials.gov

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