- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07327762
Comparison of Two Different Suture Knot Techniques on Post-Operative Trismus and Swelling After Impacted Third Molar Surgery (Impacted molar)
COMPARISON OF TWO DIFFERENT SUTURE KNOT TECHNIQUES ON POST-OPERATIVE TRISMUS AND SWELLING AFTER IMPACTED THIRD MOLAR SURGERY
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pakistan
-
Rawalpindi, Pakistan, Pakistan, 46200
- Watim Medical and Dental College
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
• Healthy individuals
- Gender: male and female
- Age: 18-45 years
- Mandibular third molar impaction all positions
- Mandibular third molar impaction all classes
Exclusion Criteria:
• 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: locking suture
effect of locking suture on trismus and swelling
|
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
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.
|
|
Experimental: non locking suture
effect of non locking suture on trismus and swelling
|
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
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
3 days and 7 days post operatively
|
|
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.
|
Post operative day three and day seven
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- WMDCR/ERB/2023/50
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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