Reduction of scar and improvement of lip function by using injectable drugs.
Phase 4
- Conditions
- Health Condition 1: M268- Other dentofacial anomalies
- Registration Number
- CTRI/2024/04/065696
- Lead Sponsor
- Dr Shipra Bharti
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1)Patients aged 20 to 50 years
2)Patients indicated for surgical procedures (orthognathic, trauma and pathology) requiring exposure of anterior maxilla or mandible by vestibular incision.
3)Patients categorized under ASA status I & II
Exclusion Criteria
1)Patients with lacerations or pathological changes in the lip
2)Patients with infection in the surgical site
3)Patients categorized under ASA status III, IV
4)Patients lesser then 20years and greater than 50years
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1)Pain by clinical evaluation, using Numerical pain rating scale <br/ ><br>2)Tissue fibrosis, by biochemical evaluation of serum lactate Dehydrogenase <br/ ><br>3)Tissue fibrosis by Ultrasonographic evaluation <br/ ><br> <br/ ><br>Timepoint: 1)1st 3rd & 7th preoperative day & 2nd to 8th postoperative week <br/ ><br>2)Tissue fibrosis, by biochemical evaluation of serum lactate Dehydrogenase -preoperative and 8th postoperative week <br/ ><br>3)Tissue fibrosis by Ultrasonographic evaluation- preoperative and 8th postoperative week <br/ ><br> <br/ ><br>
- Secondary Outcome Measures
Name Time Method <br/ ><br>1.Mouth opening in mm <br/ ><br>2.Inter commissural distance (at rest, pursing & wide grin) <br/ ><br>3.Lip elasticity index <br/ ><br>4.Oral access <br/ ><br>5.Healing of incision <br/ ><br>6.Vestibular depth <br/ ><br> <br/ ><br>Timepoint: 1.Mouth opening – pre-op day, <br/ ><br> 1st to 8th post-op week <br/ ><br>2.Lip movements - pre op <br/ ><br> day,1st to 8th post-op week <br/ ><br>3.Healing of incision -1st to <br/ ><br> 8th post-op week <br/ ><br>4.Vestibular depth - pre op <br/ ><br> day,1st to 8th post-op week <br/ ><br>