TrismusImpacted molarNCT07327762
Comparison of Two Different Suture Knot Techniques on Post-Operative Trismus and Swelling After Impacted Third Molar Surgery
A study testing locking and non locking suture techniques and non locking suture technique in people with Trismus and Swelling, run by Watim Medical & Dental College at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 45 yearsHealthy volunteers can take part
- What is being tested?
- locking and non locking suture techniques and non locking suture technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2025to 31 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Up to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- • Healthy individuals
- Gender: male and female
- Age: 18-45 years
- Mandibular third molar impaction all positions
- Mandibular third molar impaction all classes
Who cannot join
- • 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: COMPARISON OF TWO DIFFERENT SUTURE KNOT TECHNIQUES ON POST-OPERATIVE TRISMUS AND SWELLING AFTER IMPACTED THIRD MOLAR SURGERY
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.
Read the detailed description
The rationale behind conducting a comparative analysis of two different suture knot techniques on postoperative trismus and swelling following impacted third molar surgery stems from the imperative need to optimize patient outcomes and improve surgical practices. Impacted third molar surgery, while a routine procedure in oral and maxillofacial surgery, often presents challenges in managing postoperative complications, particularly trismus and swelling, which can significantly impact patients' comfort, recovery, and overall satisfaction.
- Being tested
- locking and non locking suture techniques, non locking suture technique
- Medical subject headings
- Trismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
locking and non locking suture techniquesProcedure or surgery
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
non locking suture techniqueProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| locking suture | Experimental | effect of locking suture on trismus and swelling Receives: Procedure: locking and non locking suture techniques; Procedure: non locking suture technique |
| non locking suture | Experimental | effect of non locking suture on trismus and swelling Receives: Procedure: locking and non locking suture techniques; Procedure: non locking suture technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Post operative day three and day seven
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start1 Jan 2025
- Primary completion31 Aug 2025
- Study completion31 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TrismusStudies 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
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Watim Medical & Dental College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shania Haq, Watim Medical & Dental College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07327762
- Sponsor's protocol ID
- WMDCR/ERB/2023/50
- Acronym
- Impacted molar
- Status last verified
- Dec 2025
- First submitted
- 18 Nov 2025
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPARISON OF TWO DIFFERENT SUTURE KNOT TECHNIQUES ON POST-OPERATIVE TRISMUS AND SWELLING AFTER IMPACTED THIRD MOLAR SURGERY
- ClinicalTrials.gov ID
- NCT07327762
- Acronym / sponsor ID
- Impacted molar / WMDCR/ERB/2023/50
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Watim Medical & Dental CollegeUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 8 Jan 2026 (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.
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.
Detailed description
The rationale behind conducting a comparative analysis of two different suture knot techniques on postoperative trismus and swelling following impacted third molar surgery stems from the imperative need to optimize patient outcomes and improve surgical practices. Impacted third molar surgery, while a routine procedure in oral and maxillofacial surgery, often presents challenges in managing postoperative complications, particularly trismus and swelling, which can significantly impact patients' comfort, recovery, and overall satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| locking suture | Experimental | Procedure: locking and non locking suture techniques, Procedure: non locking suture techniqueeffect of locking suture on trismus and swelling |
| non locking suture | Experimental | Procedure: locking and non locking suture techniques, Procedure: non locking suture techniqueeffect of non locking suture on trismus and swelling |
Who may qualify
- Ages
- Up to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- • Healthy individuals
Key exclusion criteria (5 listed)
- • Patients with ASA status III and above
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 |
|---|---|---|
| locking and non locking suture techniquesThe 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 | Procedure or surgery | locking suture, non locking suture |
| non locking suture techniqueThe 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. | Procedure or surgery | locking suture, non locking suture |
Primary outcome
effect of locking and non locking suture technique on trismus
Time frame: 3 days and 7 days post operatively
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.
Effect of locking and unlocking sutures on facial swelling
Time frame: Post operative day three and day seven
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing locking and non locking suture techniques and non locking suture technique in people with Trismus and Swelling, 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 5 inclusion and 5 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: finished, as of the sponsor's last update on 1 Sep 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
effect of locking and non locking suture technique on trismus (time frame: 3 days and 7 days post operatively). 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 1 Sep 2026.