NCT07327762

Brief Summary

To compare the two different suture knot techniques, locked and unlocked, in terms of mean on postoperative trismus and swelling after impacted mandibular third molar surgery.

Trial Health

63
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Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
7mo left

Started Jul 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

November 18, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 8, 2026

Completed
6 months until next milestone

Study Start

First participant enrolled

July 1, 2026

Expected
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2027

Last Updated

January 8, 2026

Status Verified

December 1, 2025

Enrollment Period

7 months

First QC Date

November 18, 2025

Last Update Submit

December 25, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • effect of locking and non locking suture technique on trismus

    Trismus will be evaluated by measuring the distance between the mesio-incisal corners of the upper and lower right central incisors at maximum mouth opening in mm, using Castroviejo instrument.

    3 days and 7 days post operatively

  • Effect of locking and unlocking sutures on facial swelling

    The facial swelling in cm will be determined by measuring the distance from the corner of the mouth to the attachment of the earlobe following the bulge of the cheek and the distance from the outer canthus of the eye to the angle of the mandible using a plastic measuring tape.

    Post operative day three and day seven

Study Arms (2)

locking suture

EXPERIMENTAL

effect of locking suture on trismus and swelling

Procedure: locking and non locking suture techniquesProcedure: non locking suture technique

non locking suture

EXPERIMENTAL

effect of non locking suture on trismus and swelling

Procedure: locking and non locking suture techniquesProcedure: non locking suture technique

Interventions

The participating patients will be randomly assigned into two groups, i.e. receiving locked (L) or unlocked (UL) sutures, using a lottery method. Equal patients will be assigned in both groups. In group L (Locked suturing), the flap will be repositioned and sutured with the locked technique (straight-reverse-straight) hermetically using 3-0 black silk. In group UL (Unlocked suturing), the flap will be repositioned and sutured with the unlocked technique (three straight knots) loosely using 3-0 black silk. Demographic details (including name, age, gender, contact) will be obtained and recorded on specific data collection forms. On the day of surgery before the surgery commences, measurements will be taken for trismus and swelling which will be entered on the data collection form. Trismus will be evaluated by measuring the distance between the mesio-incisal corners of the upper and lower right central incisors at maximum mouth opening in mm, using Castroviejo instrument.

locking suturenon locking suture

The participating patients will be randomly assigned into two groups, i.e. receiving locked (L) or unlocked (UL) sutures, using a lottery method. Equal patients will be assigned in both groups. In group L (Locked suturing), the flap will be repositioned and sutured with the locked technique (straight-reverse-straight) hermetically using 3-0 black silk. In group UL (Unlocked suturing), the flap will be repositioned and sutured with the unlocked technique (three straight knots) loosely using 3-0 black silk. Demographic details (including name, age, gender, contact) will be obtained and recorded on specific data collection forms. On the day of surgery before the surgery commences, measurements will be taken for trismus and swelling which will be entered on the data collection form. Trismus will be evaluated by measuring the distance between the mesio-incisal corners of the upper and lower right central incisors at maximum mouth opening in mm, using Castroviejo instrument. The facial swel

locking suturenon locking suture

Eligibility Criteria

AgeUp to 45 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Healthy individuals
  • Gender: male and female
  • Age: 18-45 years
  • Mandibular third molar impaction all positions
  • Mandibular third molar impaction all classes

You may not qualify if:

  • Patients with ASA status III and above
  • Patients requiring multiple extractions in same appointment
  • Patients allergic to Lignocaine
  • Patients in whom adrenaline is contraindicated
  • Medically compromised individual such as those with poorly controlled diabetes, hypertension and pregnancy, etc.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Watim Medical and Dental College

Rawalpindi, Pakistan, 46200, Pakistan

Location

MeSH Terms

Conditions

Trismus

Condition Hierarchy (Ancestors)

SpasmNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Masking Description
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: By undertaking a comparative analysis of two distinct suture knot techniques, this study seeks to address this knowledge gap and provide evidence-based insights into the optimal approach for wound closure in impacted third molar surgery. Understanding the differential effects of suture techniques on postoperative trismus and swelling is essential for informing clinical decision-making, guiding surgical practices, and ultimately enhancing patient care. Postoperative complications are common after this surgery and can be attributed to various factors.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 18, 2025

First Posted

January 8, 2026

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

January 31, 2027

Last Updated

January 8, 2026

Record last verified: 2025-12

Locations