NCT07247929

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 15, 2024

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 14, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 25, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2026

Completed
Last Updated

November 25, 2025

Status Verified

September 1, 2025

Enrollment Period

1.5 years

First QC Date

November 14, 2025

Last Update Submit

November 20, 2025

Conditions

Pain (Visceral, Somatic, or Neuropathic)

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    2nd postoperative day

Study Arms (2)

flap technqiue

EXPERIMENTAL

Surgical extraction with mucoperiosteal flap elevation, bone guttering, tooth sectioning, and suturing.

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.

Procedure: flapless technquie arm b

Interventions

flap technqiue for mandibular third molar extraction Arm APROCEDURE

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.

flap technqiue
flapless technquie arm bPROCEDURE

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

flapless technquie

Eligibility Criteria

Age18 Years - 45 Years
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Watim Medical College&Dental Hospital

Islamabad, Islamabad, 44000, Pakistan

RECRUITING

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

dr huma bajar huma bajar, bds

CONTACT

00923243322292humabajar@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
prinicpal investigator

Study Record Dates

First Submitted

November 14, 2025

First Posted

November 25, 2025

Study Start

August 15, 2024

Primary Completion

February 15, 2026

Study Completion

April 15, 2026

Last Updated

November 25, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)