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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorG. d'Annunzio University

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

systemic diseases

coagulation disorders

medications affecting periodontal status in the previous 6 months

pregnancy or lactation

Trial design

Treatments tested in this trial

  • Compressive Sutures (CSs) group
  • Without Compressive Sutures (WCSs) group

Treatment groups

40 Participants
are divided into 2 treatment groups

Sponsors and collaborators