- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07247929
Postoperative Pain and Swelling After Flap vsFlapless Technique For Mandibular Third Molar Surgery
Comparison of Postoperative Pain and Swelling in Flap Versus Flapless Technique for Surgical Removal of Partially Impacted Mandibular Third Molars: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Impacted mandibular third molars frequently require surgical extraction, often involving mucoperiosteal flap elevation and bone removal. These steps may contribute to postoperative complications such as pain, swelling, and trismus. Minimally invasive alternatives, including flapless extraction, aim to reduce surgical trauma.
This study compares postoperative pain and swelling after flap versus flapless techniques in patients with partially impacted mesioangular mandibular third molars. Pain will be assessed using a 10-point Visual Analogue Scale (VAS), and swelling will be measured using standardized anthropometric facial measurements. A total of 160 participants will be randomized into two equal groups. All procedures will be performed by a single surgeon to reduce bias.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: dr huma bajar huma bajar, bds
- Phone Number: 00923243322292
- Email: humabajar@yahoo.com
Study Locations
-
-
Islamabad
-
Islamabad, Islamabad, Pakistan, 44000
- Recruiting
- Watim Medical College&Dental Hospital
-
Contact:
- dr huma bajar huma bajar, bds
- Phone Number: 00923243322292
- Email: humabajar@yahoo.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Age 18-45 years
- Either gender
- Partially impacted mesioangular mandibular third molar confirmed clinically and radiographically
- Second episode of pericoronitis
- Swelling present on the affected side
- No bone recession or periodontal disease on radiograph
Exclusion Criteria:
HIV or HBV infection
- Diabetes or other metabolic disorders
- Bleeding disorders including von Willebrand disease, thalassemia, hemophilia, thrombocytosis, or thrombocytopenia
- Periapical infection or acute pericoronitis at time of surgery
- Severe trismus
- Immunocompromised status
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: flap technqiue
Surgical extraction with mucoperiosteal flap elevation, bone guttering, tooth sectioning, and suturing.
|
Surgical extraction performed using a mucoperiosteal flap.
A Ward's or modified Ward's incision is placed with a No. 15 blade.
The flap is elevated to expose bone, followed by bone guttering with a straight fissure bur under saline irrigation.
Tooth sectioning is carried out and fragments are removed.
The socket is irrigated with saline and the flap is repositioned and sutured with 3-0 black braided silk.
|
|
Experimental: flapless technquie
Surgical extraction without flap elevation, minimal gingival reflection, bone guttering, and no suturing.
|
Surgical extraction of partially impacted mandibular third molar without raising a mucoperiosteal flap.
Only minimal gingival reflection is performed using a periosteal elevator.
Bone guttering and tooth sectioning are carried out using a bur under saline irrigation.
Tooth fragments are removed.
The socket is irrigated with saline and 0.2% chlorhexidine.
No sutures are placed, and the site is allowed to heal by secondary intention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
postoperative pain score
Time Frame: 2nd postoperative day
|
Pain will be assessed on the 2nd postoperative day using the Visual Analogue Scale (VAS) ranging from 0 = no pain to 10 = worst pain.
Patients will be instructed to rate their pain by marking a score on the 10-point VAS.
|
2nd postoperative day
|
|
facial swelling measurement
Time Frame: 2nd postoperative day
|
Measurements will be recorded in millimeters as: A = Gonion-Tragus B = Gonion-Outer canthus C = Gonion-Ala D = Gonion-Angle of mouth E = Gonion-Pogonion Total swelling = A + B + C + D + E. This method is described in the Operational Definition section of your synopsis. |
2nd postoperative day
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- WMC-OMFS-FLAPvsFLAPLESS-2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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