Health Condition 1: O- Medical and Surgical
Conditions
Interventions
Intervention1: Trusilk: Trusilk natural non-absorbable black braided silk suture of size 3-0 will be used to close the oral mucosal incisions. The suture material will be removed after 7-14 days depen
Sponsors
Healthium Medtech PvtLtd formerly Sutures India Pvt Ltd
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare tissue reaction/inflammation with TrusilkÃ?® (Healthium) and MersilkÃ?® (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
| Measure | Time frame |
|---|---|
| 1. To assess the incidence of tissue reaction and infection between the two groups 2. To assess the effect of suture material on wound healing and other surgical outcomes 3. To assess overall intraoperative handling between the two sutures 4. To compare the common post-surgical complications between two sutures 5. To compare bacterial accumulation on both suture materials (Exploratory outcome)Timepoint: Day 3 Day 7 Day 12 Day 30 Month 3 | — |
Countries
India
Contacts
Public ContactDr Ashok Moharana
Healthium Medtech Pvt.Ltd. (formerly Sutures India Pvt. Ltd.)
Outcome results
None listed