Analysis of Early Healing of Sutures in Periodontal Surgery

N/AEnrolling By InvitationNCT06201377

Ana María García de la Fuente60 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

TRIPLE

Enrollment

Conditions

Post-Surgical Complication Periodontal Inflammation Surgical Site Infection

Interventions

Periodontal Access Surgery+ Suture with chlorhexidineOTHER

Periodontal conventional surgery will be performed as treatment of periodontal diseases in patients who present active periodontal pockets. At the end of the surgery, the surgeon will suture the flap with the absorbable polyglactin 910 suture coated with chlorhexidine (Novosyn Chlorhexidine). Standardized post-surgical recommendations will be followed.

Periodontal Access Surgery+ Suture without chlorhexidineOTHER

Periodontal conventional surgery will be performed as treatment of periodontal diseases in patients who present active periodontal pockets. At the end of the surgery, the surgeon will suture the flap with the absorbable polyglactin 910 suture (Novosyn). Standardized post-surgical recommendations will be followed.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Department fo Stomatology, Faculty of Medicine and Nursery, University of the Basque Country

Leioa, Biscay, Spain

Outcomes

Primary Outcomes

Periodontal healing index (PQI) (Landry et al., 1988)

This periodontal healing index was described by Landy et al. in 1988. The index consists of the assessment of 5 clinical parameters (tissue color, bleeding on palpation, presence of granulation tissue, presence of suppuration, and healing of the surgical margin). The index will be from 1 to 5, where point 1 was defined as "healing way scarce" and point 5 such as "excellent healing" (Landry RG, Turnbull RS, Howley T. Effectiveness of benzydamine HCL in the treatment of periodontal post-surgical patients. Res Clin Forums. 1988; 10:105-118)

Time frame: at 7 days, 14 days, 1 month and 2 months after surgery

Secondary Outcomes

Pre-surgical pain

This variable will be collected by means of a questionnaire included in the pain diary (called "UPV/EHU pain diary" Fernández Jiménez et al., 2021).The examiner will record whether the subject has had any regional head and neck pain in the last month prior to the operation and whether any pain was present in the immediate pre-surgical period (last 24 hours). If so, its intensity will be recorded (visual analogue scale (from 0 to 10, where 0 represents no pain and 10 represents the maximum pain known to the subject.

Time frame: The day of the surgical intervention

Clinical level of central sensitization of the subject (Subclinical, Medium, Moderate, Severe and Extreme)

Prior to surgery a Central Sensitization Questionnaire (CSC) will be used (Cuesta-Vargas et al., 2016), in which each subject is asked about the frequency with which they perceive 25 symptoms and will be given a score of 0-4. This will finally establish a clinical level in a range of 0-100 (Subclinical: 0-29 points; Medium: 30-39; Moderate: 40-49; Severe: 50-59; Extreme: 60-100).

Time frame: Prior to surgery

Post-surgical pain

The subject will be given a pain diary (PD) based on the VAS (Fernández-Jiménez et al., 2021) with instructions for its completion. The subject will be instructed to record their perception of post-surgical pain at 2 and 4 hours, then every 8 hours for the first 3 days and finally daily at the end of the day for a week or until remission. Specifically, the subject will record three variables: the greatest intensity of the pain (0-100), its duration (minutes or hours) and whether any analgesic treatment has been necessary (No or Yes: Which one?). This information will be recorded until the pain has subsided

Data from ClinicalTrials.gov

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