A clinical trial to study effect of bio-glue in patients for the closure of wounds following oral surgery.

Phase 4

Completed

• Conditions: Impacted teeth, (2) ICD-10 Condition: K116||Mucocele of salivary gland, (3) ICD-10 Condition: K136||Irritative hyperplasia of oral mucosa, (4) ICD-10 Condition: K069||Disorder of gingiva and edentulousalveolar ridge, unspecified, (5) ICD-10 Condition: K041||Necrosis of pulp, (6) ICD-10 Condition: K053||Chronic periodontitis,

• Registration Number: CTRI/2022/12/048035
• Lead Sponsor: Dr Kanishk Srivastava

Brief Summary

In the study we are going evaluate theclinical post-operative healing after the use of cyanoacrylate tissue adhesivein intraoral wound closure. The employed tissue adhesive is PeriAcryl90 High Viscosity (GluStitch), it is a blend a of n-butyl and 2-octylcyanoacrylate. It is a violet colour liquid monomer packed in a container thatpolymerizes on contact with aqueous-containing substances (Hydroxyl ions), suchas blood and moisture, it sets within 5 to 10 seconds. Cyanoacrylatetissue adhesive is biocompatible material and takes about 7 - 10 days to sloughoff the mucosa after application.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-14
• Study Completion: 2023-01-31
• Last Update Posted: 2023-01-31

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• 1.Patient with the age 18 years and above will be selected for the study.
• 2.Minor oral surgical procedures were closure of intra oral surgical incisions are required 3.Procedures like, multiple extractions, canine exposure, transalveolar extractions, surgical extraction of impacted third molars and canine, alveoloplasty, biopsy, and excision of mucocele are included in the study.
• 5.Patient who agreed to follow the study protocol.

Exclusion Criteria

• Patients will not be considered for the study with the following criteria: 1.Immunocompromised patients.
• 2.Uncontrolled diabetes 3.Bleeding disorders 4.Uncooperative patients 5.Neurological disorders.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improved and early wound healing of test site	1 week

Secondary Outcome Measures

Name	Time	Method
Efficacy of tissue adhesive for early wound healing of the surgical site, healing will be much better and patients compliance will be more towards the product under investigation.	3rd and 7th day post op.

Trial Locations

Locations (1)

Thai Moogambigai Dental College and Hospital; 🇮🇳 Chennai, TAMIL NADU, India

Thai Moogambigai Dental College and Hospital

🇮🇳Chennai, TAMIL NADU, India

Dr Kanishk Srivastava

Principal investigator

8762051995

kanishk013@gmail.com