Fate of knotless barbed sutures in 3rd molar surgery

Not yet recruiting

• Conditions: Impacted mandibular 3rd molars; Impacted teeth,

• Registration Number: CTRI/2023/01/049130
• Lead Sponsor: Futura Surgicare Pvt Ltd

Brief Summary

Patients fulfilling the inclusion and exclusion criteria will be included in the study. All the patients will be explained about the procedures involved and those willing to be a part of the study will be enrolled, a written consent will be obtained. A simple randomization will be done to obtain patients in two groups of 17 patients each-Group A and Group B. Group A- Terence Ward’s incision will be placed Group B- Koener’s incision will be placed A case proforma will be made to record the history in detail and the associated signs and symptoms. Intraoral surgical incisions to access surgical sites in mandibular 3rd molar impaction will be based on radiographic and clinical evaluation, the type of incision will be decided (Koener’s or Terence ward’s incision). The surgical removal of tooth will be carried out under local anesthseia 2% lignocaine with 1:80,000 adrenaline with proper aseptic precautions. The same surgeon will operate on all patients to avoid any operator-based bias. Patients will be administered antibiotic one hour before surgery; amoxicillin 1g, or clindamycin 600mg/erythromycin 500mg if the patient is allergic to penicillin which will be followed by placement of incision, buccal and disto- buccal bone guttering using round bur under copious saline irrigation. Tooth sectioning will be done when required. Following tooth removal, surgical site will be thoroughly debrided and suturing will be done submucosally using simple continuous technique using Polydioxanone barbed sutures DURABARB, Dolphin sutures (CE ISO 13485, ISO 9001:2008 AND WHO; GMP certificate). The entire suturing time from the retrieval of tooth to the closure or completion of suturing will be noted using a stop watch. Standard post operative instructions will be given. Post operatively analgesic combination drug of diclofenac 50mg paracetamol 325mg and seratopeptidase 10mg is given every 8 hourly for 3 days. The following parameters will be assessed clinically post operatively: . Wound closure time will be assessed from start of suturing till the time of complete flap approximation is done using a stop watch for the assessment of operator’s difficulty in placement of barbed sutures. 1 On post operative days 1, 3 ,5 and 7 1)Post operative pain will be assessed using Visual Analogue Scale (VAS) and graded from 0-10 (no pain to worst pain). 2)Wound healing and tissue approximation will be assessed based on Landry’s index which is based on numerous clinical features such as tissue colour, presence of bleeding on palpation, presence of granulation tissue, incision margin and presence of suppuration.7 3)Facial swelling will be assessed by using Gogulanathan M. et. Al 2015. 4) Mouth opening will be assessed by measuring inter incisal distance.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-01-19
• Study Start: 2023-01-21

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

• Patients with impacted mandibular 3rd molars 1.classified according to Pell and Gregory.
• Patients of age groups 18-35 years.
• Patients with adequate mouth opening (approx.

Exclusion Criteria

• Patients with debilitating systemic diseases such as cardiovascular diseases, renal diseases, neurological deficit etc.
• Patients on immunosuppressive diseases such as HIV, Hepatitis.
• Patients with deleterious habits such as smoking, alcohol consumption.
• Patients who do not consent for the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1)Post operative pain will be assessed using Visual Analogue Scale (VAS) and graded from 0-10	On post operative days 1, 3 , 5 ,7
(no pain to worst pain).	On post operative days 1, 3 , 5 ,7
2)Wound healing and tissue approximation will be assessed based on Landry’s index which is	On post operative days 1, 3 , 5 ,7
based on numerous clinical features such as tissue colour, presence of bleeding on palpation,	On post operative days 1, 3 , 5 ,7
presence of granulation tissue, incision margin and presence of suppuration.	On post operative days 1, 3 , 5 ,7
3)Facial swelling will be assessed by using Gogulanathan M. et. Al 2015.	On post operative days 1, 3 , 5 ,7
4) Mouth opening will be assessed by measuring inter incisal distance.	On post operative days 1, 3 , 5 ,7

Secondary Outcome Measures

Name	Time	Method
1)Post operative pain will be assessed using Visual Analogue Scale (VAS) and graded from 0-10	(no pain to worst pain).

Trial Locations

Locations (1)

Bapuji Dental College and Hospital; 🇮🇳 Davanagere, KARNATAKA, India

Bapuji Dental College and Hospital

🇮🇳Davanagere, KARNATAKA, India

Dr Disha Dip

Principal investigator

8904317103

myselfdishadip@gmail.com