Different Suture Diameters in Periodontal Plastic Surgery

NCT06698393 | Not Yet Recruiting DMC

• 1 other identifier: 16112024
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled clinical trial aims to compare the clinical outcomes of using non-resorbable polyamide sutures of different diameters (3.0 vs. 6.0) for securing an advanced coronary flap (CAF) and subepithelial connective tissue graft (SCTG) in 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 sutured with non-resorbable polyamide thread of 3.0 diameter, while the other 20 participants (control group) will receive the same procedure sutured with a 6.0 diameter thread. 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 Recession

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)

Suture 3.0 Group

ACTIVE COMPARATOR

Coronally Advanced Flap Combined with a Connective Tissue Graft Harvested from the Palate for the Treatment of RT1 Gingival Recession. The flap was repositioned using a non-resorbable polyamide suture with a diameter of 3.0

Procedure: Suture 3.0 Group

Suture 6.0 Group

EXPERIMENTAL

Coronally Advanced Flap Combined with a Connective Tissue Graft Harvested from the Palate for the Treatment of RT1 Gingival Recession. The flap was repositioned using a non-resorbable polyamide suture with a diameter of 6.0

Procedure: Suture 6.0 Group

Interventions

Suture 3.0 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 at the la. The de-epithelialised graft will be sutured at the level of the de-epithelialised anatomical papillae.The flap will be repositioned coronally suturing the anatomical papillae on the surgical ones, using a Non-Resorbable Polyamide Suture of 3.0 Diameter.

Suture 3.0 Group

Suture 6.0 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 at the la. The de-epithelialised graft will be sutured at the level of the de-epithelialised anatomical papillae.The flap will be repositioned coronally suturing the anatomical papillae on the surgical ones, using a Non-Resorbable Polyamide Suture of 6.0 Diameter.

Suture 6.0 Group

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, Italy

Location

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

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

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, OUTCOMES ASSESSOR
• 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 18, 2024
• First Posted: November 21, 2024
• Study Start: December 1, 2024
• Primary Completion: May 31, 2025
• Study Completion: November 30, 2025
• Last Updated: November 21, 2024

Record last verified: 2024-11

Locations

IT (1)