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

NCT06701786 | Not Yet Recruiting DMC

• 1 other identifier: 201124
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Gingival Recessions; Gingival Recession, Mucogingival Surgery; Suture

Keywords

Periodontal Plastic Surgery; Gingival recession; Coronally Advanced Flap; Suture

Outcome Measures

Primary Outcomes (1)

• Complete root coverage

  Percentage of experimental sites that achieved complete root surface coverage.

  6 months

Secondary Outcomes (8)

• Gingival Recession

  6 months

• Gingival thickness

  6 months

• Keratinized tissue width

  6 months

• Clinical attachment level

  6 months

• Pocket depth

  6 months

Study Arms (2)

CAF+SCTG+ Compressive Suture

EXPERIMENTAL

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.

Procedure: Compressive Sutures (CSs) group

CAF+ SCTG alone

ACTIVE COMPARATOR

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.

Procedure: Without Compressive Sutures (WCSs) group

Interventions

Compressive Sutures (CSs) group 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+ Compressive Suture

Without Compressive Sutures (WCSs) group 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.

CAF+ SCTG alone

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• G. d'Annunzio University: lead

Study Sites (1)

Department of Innovative Technologies in Medicine and Dentistry, Chieti,

Chieti, Chieti, 66100, Italy

Location

MeSH Terms

Conditions

Gingival Recession

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Central Study Contacts

Michele Paolantonio, MD, DDS

CONTACT

3395204073; michelepaolantonio@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Model Details: Randomized Controlled Clinical Trial

Study Record Dates

• First Submitted: November 19, 2024
• First Posted: November 22, 2024
• Study Start: December 1, 2024
• Primary Completion: May 31, 2025
• Study Completion: November 30, 2025
• Last Updated: November 22, 2024

Record last verified: 2024-11

Locations

IT (1)