- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07723326
Comparison of Electrocautery and Scalpel Blade Incisions of Impacted Mandibular Third Molars
Comparison of Electrocautery and Scalpel Blade Incisions on Postoperative Pain, Intraoperative Blood Loss, and Wound Healing Following Surgical Extraction of Impacted Mandibular Third Molars: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Surgical extraction of impacted mandibular third molars is one of the most common procedures in oral and maxillofacial surgery. The type of incision used may influence postoperative outcomes, including pain, bleeding, and wound healing. Electrocautery offers simultaneous cutting and coagulation, potentially reducing intraoperative blood loss and improving surgical visibility, whereas scalpel incisions produce precise tissue cuts without thermal injury.
This prospective, two-arm, parallel-group, randomized controlled trial will compare electrocautery and scalpel blade incisions in patients undergoing surgical extraction of impacted mandibular third molars. Seventy-eight participants will be randomly assigned to either Arm A (scalpel blade incision) or Arm B (electrocautery incision). All other surgical and perioperative variables, including local anesthesia, flap design, irrigation, suture material, and postoperative medications, will be standardized.
The primary outcome is postoperative pain assessed using a Visual Analogue Scale at 24 hours, 48 hours, and 7 days. Secondary outcomes include intraoperative blood loss and wound healing assessed using the Landry Wound Healing Index at 1 and 4 weeks. The findings of this study will provide evidence regarding the most appropriate incision technique for impacted mandibular third-molar surgery.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Muhammad Usama, BDS/FCPS
- Phone Number: +923325595484
- Email: usamakhan123478@gmail.com
Study Contact Backup
- Name: Uzair Luqman, BDS/FCPS
- Phone Number: +923215080354
- Email: uzair.luqman@riphah.edu.pk
Study Locations
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Islamabad, Pakistan, 44000
- Islamic International Dental Hospital
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Contact:
- Muhammad Usama, BDS/FCPS
- Phone Number: +923325595484
- Email: usamakhan123478@gmail.com
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Principal Investigator:
- Uzair Luqman, BDS/FCPS
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Male and female patients.
- Age 15 to 65 years.
- Patients requiring surgical extraction of an impacted mandibular third molar. Patients classified as ASA I or ASA II.
- Patients willing to provide written informed consent, or assent with parent/guardian permission where applicable, and attend scheduled follow-up visits
Exclusion Criteria:
* Patients with uncontrolled systemic disease or immuno-compromised status.
- Patients with bleeding disorders or those taking anticoagulant/antiplatelet drugs that cannot be safely withheld according to physician advice.
- Patients with pacemaker or implanted electrical cardiac device.
- Pregnant or lactating patients.
- Patients with acute infection, pericoronitis, facial space infection, or pus discharge at the surgical site at the time of surgery.
- Patients requiring bilateral third-molar extraction in the same sitting.
- Patients unwilling to participate or unable to return for follow-up.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: scalpel blade incision group
Participants will undergo surgical extraction of impacted mandibular third molars using a sterile No. 15 scalpel blade for the mucoperiosteal flap incision
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A sterile No. 15 stainless-steel scalpel blade will be used to make the mucoperiosteal flap incision during surgical extraction of the impacted mandibular third molar.
|
|
Experimental: electrocautery incision group
Participants will undergo surgical extraction of impacted mandibular third molars using electrocautery in cutting mode for the mucoperiosteal flap incision
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A fine electrocautery electrode in cutting mode at a standardized effective power setting will be used to make the mucoperiosteal flap incision during surgical extraction of the impacted mandibular third molar.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
postoperative pain
Time Frame: 24 hours, 48 hours, and 7 days after surgery.
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Postoperative pain at the surgical site will be assessed using a 0-10 Visual Analogue Scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain
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24 hours, 48 hours, and 7 days after surgery.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
intraoperative blood loss
Time Frame: During surgery (from first incision to final suture).
|
Total blood loss will be calculated as the increase in gauze weight plus the suction-canister volume after subtracting the recorded irrigation volume.
Results will be reported in milliliters (mL).
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During surgery (from first incision to final suture).
|
|
wound healing
Time Frame: 1 week and 4 weeks after surgery.
|
Wound healing will be assessed using the Landry Wound Healing Index, scored from 1 (very poor) to 5 (excellent).
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1 week and 4 weeks after surgery.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Uzair Luqman, BDS/FCPS, department of ORAL AND MAXILLOFACIAL SURGERY ISLAMIC INTERNATIONAL DENTAL HOSPITAL
Study record dates
Study Major Dates
Study Start (Estimated)
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
Other Study ID Numbers
- IIDC/IRC/2026/7/001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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