Pain (Visceral, Somatic, or Neuropathic)NCT07247929
Postoperative Pain and Swelling After Flap vsFlapless Technique For Mandibular Third Molar Surgery
A study testing flap technqiue for mandibular third molar extraction Arm A and flapless technquie arm b in people with Pain (Visceral, Somatic, or Neuropathic), run by Watim Medical & Dental College at 1 site in Pakistan.
Trial summary
This randomized controlled trial evaluates postoperative pain and facial swelling following surgical removal of partially impacted mandibular third molars using flap versus flapless techniques. The aim is to determine which method results in lower postoperative morbidity on the second postoperative day. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain (Visceral, Somatic, or Neuropathic)
- What is being tested?
- flap technqiue for mandibular third molar extraction Arm A and flapless technquie arm b
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Aug 2024to 15 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Watim Medical College&Dental Hospital
Islamabad, Islamabad, 44000
dr huma bajar huma bajar, bds, 00923243322292, humabajar@yahoo.com
About this study
Official title: Comparison of Postoperative Pain and Swelling in Flap Versus Flapless Technique for Surgical Removal of Partially Impacted Mandibular Third Molars: A Randomized Controlled Trial
This randomized controlled trial evaluates postoperative pain and facial swelling following surgical removal of partially impacted mandibular third molars using flap versus flapless techniques. The aim is to determine which method results in lower postoperative morbidity on the second postoperative day.
Read the 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.
- Conditions
- Pain (Visceral, Somatic, or Neuropathic)
- Being tested
- flap technqiue for mandibular third molar extraction Arm A, flapless technquie arm b
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
flap technqiue for mandibular third molar extraction Arm AProcedure or surgery
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.
flapless technquie arm bProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| flap technqiue | Experimental | Surgical extraction with mucoperiosteal flap elevation, bone guttering, tooth sectioning, and suturing. Receives: Procedure: flap technqiue for mandibular third molar extraction Arm A |
| flapless technquie | Experimental | Surgical extraction without flap elevation, minimal gingival reflection, bone guttering, and no suturing. Receives: Procedure: flapless technquie arm b |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain score
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.
Measured: 2nd postoperative day
facial swelling measurement
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.
Measured: 2nd postoperative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start15 Aug 2024
- Primary completion15 Feb 2026 (estimated)
- Study completion15 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain (Visceral, Somatic, or Neuropathic)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Watim Medical & Dental College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huma Bajar, Watim Medical & Dental College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07247929
- Sponsor's protocol ID
- WMC-OMFS-FLAPvsFLAPLESS-2025
- Status last verified
- Sep 2025
- First submitted
- 14 Nov 2025
- Last updated
- 25 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Postoperative Pain and Swelling in Flap Versus Flapless Technique for Surgical Removal of Partially Impacted Mandibular Third Molars: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07247929
- Acronym / sponsor ID
- WMC-OMFS-FLAPvsFLAPLESS-2025
- Conditions
- Pain (Visceral, Somatic, or Neuropathic)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Watim Medical & Dental CollegeUniversity, hospital or other
- Study start
- 15 Aug 2024 (actual)
- Primary completion
- 15 Feb 2026 (estimated)
- Study completion
- 15 Apr 2026 (estimated)
- First posted
- 25 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized controlled trial evaluates postoperative pain and facial swelling following surgical removal of partially impacted mandibular third molars using flap versus flapless techniques. The aim is to determine which method results in lower postoperative morbidity on the second postoperative day.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| flap technqiue | Experimental | Procedure: flap technqiue for mandibular third molar extraction Arm ASurgical extraction with mucoperiosteal flap elevation, bone guttering, tooth sectioning, and suturing. |
| flapless technquie | Experimental | Procedure: flapless technquie arm bSurgical extraction without flap elevation, minimal gingival reflection, bone guttering, and no suturing. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age 18-45 years
Key exclusion criteria (6 listed)
- HIV or HBV infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| flap technqiue for mandibular third molar extraction Arm ASurgical 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. | Procedure or surgery | flap technqiue |
| flapless technquie arm bSurgical 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 | Procedure or surgery | flapless technquie |
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing flap technqiue for mandibular third molar extraction Arm A and flapless technquie arm b in people with Pain (Visceral, Somatic, or Neuropathic), run by Watim Medical & Dental College at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact dr huma bajar huma bajar, bds (00923243322292, humabajar@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative pain score (time frame: 2nd postoperative day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025; AzTrials last refreshed its copy on 6 Nov 2026.