Comparative evaluation of hyaluronic acid impregnated mersilk, conventional mersilk and vicryl plus sutures following mandibular third molar surgery.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 78
- Locations
- 1
- Primary Endpoint
- A. Clinical Parameters
Study Overview
Brief Summary
Mandibular third molar extraction is a common oral surgical procedure frequently associated with postoperative complications such as pain, edema, trismus, hematoma, prolonged bleeding, pyrexia, and alveolar osteitis. These adverse effects can delay recovery and increase the risk of secondary infections and chronic pain. Sutures are critical in promoting wound stability and healing. This single-blinded, randomized controlled clinical trial aims to evaluate the efficacy of 1.5% hyaluronic acid (HA)-impregnated 3-0 mersilk sutures compared to conventional 3-0 mersilk and 3-0 Vicryl Plus sutures in mandibular third molar surgery. A total of 84 extraction sites will be randomly allocated into three equal groups (n=28): HA-impregnated mersilk (Group I), vicryl Plus (Group II), and conventional mersilk (Group III). Randomization will be conducted via coin flip, and outcome assessment will be blinded. Clinical wound healing will be evaluated using Landry’s Healing Index on postoperative days 1, 3, and 7. Microbial colonization will be assessed by colony-forming unit (CFU) counts, and pain levels will be measured using the Visual Analog Scale (VAS).The study hypothesizes that HA-impregnated mersilk sutures will demonstrate superior outcomes in wound healing, microbial control, and pain reduction. HA’s anti-inflammatory and antimicrobial properties may enhance tissue regeneration and minimize postoperative complications, potentially improving patient recovery and overall clinical outcomes.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- Participant and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 50.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Participants within the age group of 18 to 50 years.
- •Patients requiring surgical removal of mandibular third molars.
- •Willingness to comply with the postoperative care instructions and follow-up visits.
Exclusion Criteria
- •• Current use of medications known to affect wound healing, including corticosteroids or immunosuppressants.
- •• Patients not willing to participate in the study.
- •• Medically compromised like having diabetes, hypertension, pregnant females and anxious patients.
- •• Patients with a history of allergy to anesthetics or acute inflammation at the surgical site.
- •• Patients with existing oral infections or pericoronitis.
- •• Known allergy to local anesthetics or suture materials.
Outcomes
Primary Outcomes
A. Clinical Parameters
Time Frame: Post- operative day 1st, 3rd and 7th.
-Visual Analog Scale for pain and discomfort
Time Frame: Post- operative day 1st, 3rd and 7th.
-Landry’s Healing Index (3rd and 7th day)
Time Frame: Post- operative day 1st, 3rd and 7th.
-Clinician-rated suture handling and removal
Time Frame: Post- operative day 1st, 3rd and 7th.
Total CFU count on blood agar, chocolate agar, MacConkey agar
Time Frame: Post- operative day 1st, 3rd and 7th.
Bacterial species identification (e.g., Streptococcus, Lactobacillus)
Time Frame: Post- operative day 1st, 3rd and 7th.
B. Microbiological Parameters
Time Frame: Post- operative day 1st, 3rd and 7th.
Secondary Outcomes
No secondary outcomes reported