Analysis of Early Healing of Sutures in Periodontal Surgery

Ana María García de la Fuente

Status: Invitation-only

Conditions: Surgical Site Infection; Post-Surgical Complication; Periodontal Inflammation

Treatments: Other: Periodontal Access Surgery+ Suture with chlorhexidine; Other: Periodontal Access Surgery+ Suture without chlorhexidine

Study type: Interventional

Funder types: Other

Identifiers

NCT06201377

2023/01

Details and patient eligibility

About

The main objective is to analyze post-surgical periodontal healing after conventional periodontal surgery where an absorbable suture coated with clorhexidine (Novosyn Clorhexidine) versus conventional sutures without chlorhexidine (Novosyn) will be used a pilot randomized clinical study has been designed.

Up to authors´ knowledge until now there are no studies to evaluate periodontal healing after periodontal surgery in combination with this kind of sutures.

Full description

A total of 60 patients will be included, where the unit of study will be each stitch, among the patients attending the Dental Clinic Service of the University of the Basque Country (UPV/EHU) who require surgical periodontal treatment.

The patients will be randomly divided into two groups: the control group using a conventional suture (n=30), and the test group using a suture coated with chlorhexidine diacetate (n=30).

Suture in the control group: absorbable suture of polyglactin 910 coated with polyglactin 370 + calcium stearate without chlorhexidine (NOVOSYN) Suture in the test group: absorbable suture of polyglactin 910 coated with polyglactin 370 + calcium stearate and chlorhexidine diacetate (NOVOSYN CHLORHEXIDINE) The primary variable in this study is post-surgical healing in both groups, which will be assessed using the healing index.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients ≥ 18 years-old
• Patients who have completed the basic periodontal phase and require surgical periodontal treatment for periodontal disease control.
• Plaque index (O'Leary et al.,1972) ≤20%.
• Bleeding index (Ainamo & Bay,1975) ≤20%.

Exclusion criteria

• Patients with systemic conditions contraindicating surgery
• Patients with allergy to chlorhexidine and/or o-cymen-5-ol
• Patients allergic to non-steroidal anti-inflammatory drugs (NSAIDs)
• Pregnant or breastfeeding women
• Patients with periodontal defects requiring regenerative surgery or mucogingival surgery/periodontal plastic therapy
• Patients who have taken antibiotics in the last 3months

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

Suture with chlorhexidine

Experimental group

Description:

At the end of the surgical procedure, the flap will be sutured with an absorbable suture coated with chlorhexidine diacetate (NOVOSYN CHLORHEXIDINE)

Treatment:

Other: Periodontal Access Surgery+ Suture with chlorhexidine

Suture without chlorhexidine

Active Comparator group

Description:

At the end of the surgical procedure, the flap will be sutured with an absorbable suture coated without chlorhexidine diacetate (NOVOSYN)

Treatment:

Other: Periodontal Access Surgery+ Suture without chlorhexidine