NCT07655089

Brief Summary

This randomized controlled trial aims to compare Ward's incision and Comma incision regarding postoperative swelling following extraction of impacted mandibular third molars. Secondary outcomes include pain and bleeding assessed 48 hours after surgery. The findings will help identify the incision technique associated with better postoperative outcomes

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
116

participants targeted

Target at P50-P75 for not_applicable

Timeline
0mo left

Started Jul 2026

Shorter than P25 for not_applicable

Status
not yet 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 Progress91%
Jul 2026Aug 2026

First Submitted

Initial submission to the registry

June 6, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 17, 2026

Completed
18 days until next milestone

Study Start

First participant enrolled

July 5, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 5, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 5, 2026

Last Updated

June 17, 2026

Status Verified

June 1, 2026

Enrollment Period

1 month

First QC Date

June 6, 2026

Last Update Submit

June 12, 2026

Conditions

Keywords

Impacted Mandibular Third MolarSwelling,Oral Surgery

Outcome Measures

Primary Outcomes (2)

  • Postoperative Swelling

    Degree of postoperative swelling assessed using a Visual Analog Scale (VAS) ranging from 0 to 5, where 0 indicates no swelling and 5 indicates extremely severe swelling following extraction of impacted mandibular third molars

    48 hours after surgery

  • Postoperative Swelling

    Degree of postoperative swelling assessed 48 hours after extraction of impacted mandibular third molars using a Visual Analog Scale (VAS) ranging from 0 to 5, where 0 indicates no swelling and 5 indicates extremely severe swelling.

    48 hours after surgery

Study Arms (2)

Ward's Incision Group

EXPERIMENTAL

Standard Ward's incision with mucoperiosteal flap elevation for extraction of impacted mandibular third molar.

Procedure: Ward's IncisionProcedure: Comma Incision

Comma Incision Group

ACTIVE COMPARATOR

Comma incision flap design for extraction of impacted mandibular third molar.

Procedure: Ward's IncisionProcedure: Comma Incision

Interventions

Patients allocated to Group A will undergo extraction of impacted mandibular third molars using Ward's incision. Depending on the degree of impaction, a sulcular incision will be made from the mesiobuccal aspect of the first or second molar extending distally. A relieving incision will be placed mesially without severing the interdental papilla, followed by a distal releasing incision on the mandibular ramus. A full-thickness mucoperiosteal flap will then be elevated to facilitate tooth extraction.

Comma Incision GroupWard's Incision Group

Patients allocated to Group B will undergo extraction of impacted mandibular third molars using the Comma incision technique. The incision will begin below the second molar and extend to its distobuccal line angle, then curve smoothly upward to the gingival crest. The incision will continue as a crevicular incision around the distal aspect of the second molar. A distolingually based flap will be elevated to provide adequate exposure for extraction of the impacted third molar.

Comma Incision GroupWard's Incision Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with no periodontal pathology related to the involved tooth on clinical examination.

You may not qualify if:

  • Patients with congenital or acquired bleeding disorders. Patients with any bony lesion adjacent to the impacted third molar. Medically immunocompromised patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Sayed N, Bakathir A, Pasha M, Al-Sudairy S. Complications of Third Molar Extraction: A retrospective study from a tertiary healthcare centre in Oman. Sultan Qaboos Univ Med J. 2019 Aug;19(3):e230-e235. doi: 10.18295/squmj.2019.19.03.009. Epub 2019 Nov 5.

Central Study Contacts

Fatima Khattak Khattak

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator, Department of Operative Dentistry

Study Record Dates

First Submitted

June 6, 2026

First Posted

June 17, 2026

Study Start

July 5, 2026

Primary Completion (Estimated)

August 5, 2026

Study Completion (Estimated)

August 5, 2026

Last Updated

June 17, 2026

Record last verified: 2026-06