Clinical trial NCT06698393: Different Suture Diameters in Periodontal Plastic Surgery
Official title: Impact of Different Polyamide Suture Diameter on Clinical Outcomes in Periodontal Plastic Surgery: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Gingival Recession
Lead sponsor: G. d'Annunzio University
Sponsor class: OTHER
First posted: 2024-11-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Clinical Trial
Primary purpose: TREATMENT

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.

Detailed description: The study will be a prospective, randomized, and controlled clinical trial designed to compare two polyamide sutures of different diameters (3.0 and 6.0) used to secure a CAF + SCTG. 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 ketoprofen 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).

Eligibility criteria: 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

Primary outcomes:
measure: Complete root coverage
timeFrame: 6 months
Secondary outcomes:
measure: Gingival Recession
timeFrame: 6 months
measure: Gingival thickness
timeFrame: 6 months
measure: Keratinized tissue width
timeFrame: 6 months
measure: Clinical attachment level
timeFrame: 6 months
measure: Pocket depth
timeFrame: 6 months
measure: Discomfort
timeFrame: 4 weeks
measure: Patient-Reported Esthetic Satisfaction
timeFrame: 6 months
measure: Root Coverage Esthetic Score
timeFrame: 6 months
Other outcomes:
Locations:
city: Chieti
country: Italy
facility: Department of Innovative Technologies in Medicine and Dentistry
Study officials:
References: