Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2026-01-01 @ 8:38 AM
Study NCT ID:
NCT06698393
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-11-21
First Post:
2024-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Different Suture Diameters in Periodontal Plastic Surgery
Sponsor:
G. d'Annunzio University
Organization:
Study Overview
Official Title:
Impact of Different Polyamide Suture Diameter on Clinical Outcomes in Periodontal Plastic Surgery: a Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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).
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).
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: