| CTRI Number |
CTRI/2023/01/049130 [Registered on: 20/01/2023] Trial Registered Prospectively |
| Last Modified On: |
19/01/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Fate of knotless barbed sutures in 3rd molar surgery |
|
Scientific Title of Study
|
Evaluation of primary wound healing in mandibular third molar incisions(Terence wards incision and Koeners incision) using knotless barbed sutures-A randomised control trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Disha Dip |
| Designation |
Post graduate |
| Affiliation |
Bapuji Dental College and Hospital |
| Address |
Room no. 2,Department of oral and maxillofacial reconstructive surgery, Bapuji Dental College and Hospital
MCC B Block
Davanagere
KARNATAKA
577004
India |
| Phone |
8904317103 |
| Fax |
|
| Email |
myselfdishadip@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr H R SHIVAKUMAR |
| Designation |
PROFESSOR |
| Affiliation |
Bapuji Dental College and Hospital |
| Address |
Room no. 2,Department of oral maxillofacial and reconstructive surgery, Bapuji Dental College and Hospital
MCC B Block
Davanagere
KARNATAKA
577004
India |
| Phone |
9448122883 |
| Fax |
|
| Email |
drshivu522@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Disha Dip |
| Designation |
Post graduate |
| Affiliation |
Bapuji Dental College and Hospital |
| Address |
Room no. 2,Department of oral and maxillofacial reconstructive surgery, Bapuji Dental College and Hospital
MCC B Block
Davanagere
KARNATAKA
577004
India |
| Phone |
8904317103 |
| Fax |
|
| Email |
myselfdishadip@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dolphin Sutures
Futura surgicare pvt ltd
29,Balanjaneya temple street,KGE layout, RMV II stage, Bangalore-560094 |
|
|
Primary Sponsor
|
| Name |
Futura Surgicare Pvt Ltd |
| Address |
29,Balanjaneya Temple Street, KGE Layout, RMV II Stage , Bangalore 560094 |
| Type of Sponsor |
Other [Surgical Products Company] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Disha Dip |
Bapuji Dental College and Hospital |
Room no. 2, Department of oral and maxillofacial reconstructive surgery, MCC B Block
Davanagere
KARNATAKA |
8904317103
myselfdishadip@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board,Bapuji Dental College and Hospital,Davangere |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Impacted mandibular 3rd molars |
| Patients |
(1) ICD-10 Condition: K011||Impacted teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Efficacy of Knotless barbed sutures in 2 different intraoral incisions |
1. To compare wound healing and wound approximation between Koener’s incision and
Terence ward’s incision using barbed sutures.
2. To compare operator-based difficulty in placing barbed sutures between Koener’s
incision and Terrence ward’s incision |
| Intervention |
Minor surgical intervention under local anesthesia |
The surgical removal of tooth will be carried out under local anesthseia 2% lignocaine with
1:80,000 adrenaline with proper aseptic precautions. 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) accordingly which will be
followed by 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
suture using Polydioxone barbed sutures DURABARB, Dolphin sutures (CE ISO 13485, ISO
9001:2008 AND WHO; GMP certificate). 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. 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.
3)Facial swelling will be assessed by using Gogulanathan M. et. Al 2015.
4) Mouth opening will be assessed by measuring inter incisal distance. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Patients with impacted mandibular 3rd molars 1.classified according to Pell and Gregory.
2. Patients of age groups 18-35 years.
3. Patients with adequate mouth opening (approx. 45mm |
|
| ExclusionCriteria |
| Details |
1. Patients with debilitating systemic diseases such as cardiovascular diseases, renal
diseases, neurological deficit etc.
2. Patients on immunosuppressive diseases such as HIV, Hepatitis.
3. Patients with deleterious habits such as smoking, alcohol consumption.
4. Patients who do not consent for the study |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
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.
3)Facial swelling will be assessed by using Gogulanathan M. et. Al 2015.
4) Mouth opening will be assessed by measuring inter incisal distance. |
On post operative days 1, 3 , 5 ,7 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)Post operative pain will be assessed using Visual Analogue Scale (VAS) and graded from 0-10
(no pain to worst pain).
|
On post operative days 2, 4 , 6 ,8 |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
21/01/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response (Others) - Only the data relevant to the study will be shared and personal information will be kept confidential
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - Not yet decided
- For how long will this data be available start date provided 25-06-2025 and end date provided 06-09-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
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. |