A clinical trial to compare tissue reaction/inflammation with Trusilk�® (Healthium) and Mersilk�® (Johnson & Johnson) silk sutures post primary closure of mucosa in subjects undergoing planned surgical removal of impacted mandibular third molar at 72 hours and 7 days.

Phase 4

Completed

• Conditions: Health Condition 1: O- Medical and Surgical

• Registration Number: CTRI/2020/03/024100
• Lead Sponsor: Healthium Medtech PvtLtd formerly Sutures India Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-11-06
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 132

Inclusion Criteria

1. Subjects, both male and female, aged 20-40 years

2. Subjects having mesioangular impacted mandibular 3rd molar

3. Subjects requiring mucosal suturing

4. Subjects who have given informed consent

5. Subjects classified under ASA I and II

Exclusion Criteria

1. Subjects having infected molar teeth or complicated impacted 3rd molar

2. Pregnant or lactating women

3. Subjects with history of allergy to silk or similar products

4. Subjects on drugs like aspirin, blood thinners and anticoagulant therapy

5. Subjects receiving any type of local and systemic drugs which can produce inflammation in gingival tissue

6. Subjects with history of systemic diseases such as diabetes mellitus, tuberculosis, bleeding disorders, osteoporosis, unstable or life-threatening conditions, those undergoing radiation therapies.

7. Subjects those who had the habit of drug abuse

8. Subjects already participating in another trial

9. Subjects who received an experimental drug or used an experimental medical device within 30 days prior to the planned start of procedure

10. Subjects unlikely to comply with surgical procedure or complete the scheduled follow up visit, in the opinion of investigator

11. Employees of the investigator or study center with direct involvement in the proposed study or other studies under the direction of that investigator or study center

12. Other indication or the reason for exclusion, in the opinion of investigator

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare tissue reaction/inflammation with Trusilk�® (Healthium) and Mersilk�® (Johnson & Johnson) silk sutures post primary closure of mucosa in subjects undergoing planned surgical removal of impacted mandibular third molar at 72 hours and 7 daysTimepoint: 72 hours and 7 days

Secondary Outcome Measures

Name	Time	Method
1. To assess the incidence of tissue reaction and infection between the two groups <br/ ><br>2. To assess the effect of suture material on wound healing and other surgical outcomes <br/ ><br>3. To assess overall intraoperative handling between the two sutures <br/ ><br>4. To compare the common post-surgical complications between two sutures <br/ ><br>5. To compare bacterial accumulation on both suture materials (Exploratory outcome)Timepoint: Day 3 Day 7 Day 12 Day 30 Month 3