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Optimizing Clinical Outcomes in CAF + SCTG: the Impact of Compressive Sutures
Sponsor: G. d'Annunzio University
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.
Official title: Compressive Sutures Improve Clinical Outcomes in CAF + SCTG for Treatment of RT1 Recessions"
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2024-12-01
Completion Date
2025-11-30
Last Updated
2024-11-22
Healthy Volunteers
Yes
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.
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.
Locations (1)
Department of Innovative Technologies in Medicine and Dentistry, Chieti,
Chieti, Chieti, Italy