| CTRI Number |
CTRI/2024/04/065383 [Registered on: 08/04/2024] Trial Registered Prospectively |
| Last Modified On: |
10/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
knotless wound closure vs silk suture in third molar surgery -controlled clinical trial. |
|
Scientific Title of Study
|
Evaluation of efficacy of v-loc knotless wound closure system vs silk suture in impacted third molar surgery -a split mouth randomised controlled clinical trial. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
krithic chitra banu |
| Designation |
student |
| Affiliation |
Meenakshi ammal dental college |
| Address |
Meenakshi Ammal Dental Colllege and Hospital, Allapakam main road, Janaki nagar,Madurovoyal,Chennai 600095
Department oral and maxillofacial surgery room no:5
Chennai
TAMIL NADU
600095
India |
| Phone |
9500645604 |
| Fax |
|
| Email |
krithickchitrabanu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
krithic chitra banu |
| Designation |
student |
| Affiliation |
Meenakshi ammal dental college |
| Address |
Meenakshi Ammal Dental Colllege and Hospital, Allapakam main road, Janaki nagar,Madurovoyal,Chennai 600095
Department of oral maxillofacial surgery room no:5
Chennai
TAMIL NADU
600095
India |
| Phone |
9500645604 |
| Fax |
|
| Email |
krithickchitrabanu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
krithic chitra banu |
| Designation |
student |
| Affiliation |
Meenakshi ammal dental college |
| Address |
Meenakshi Ammal Dental Colllege and Hospital, Allapakam main road, Janaki nagar,Madurovoyal,Chennai 600095
Department of oral and maxillo facial surgery.
room no:5
Chennai
TAMIL NADU
600095
India |
| Phone |
9500645604 |
| Fax |
|
| Email |
krithickchitrabanu@gmail.com |
|
|
Source of Monetary or Material Support
|
| meenakshi ammal dental college allapkam main road, madurovoyal chennai 600095, department of oral maxillo facial surgery , room no;5 c |
|
|
Primary Sponsor
|
| Name |
Dr Geetha sridaran |
| Address |
5091 8th floor, tower 5, Prestige Bella vista, Iyyapan Hangal chennai 600056. |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Geetha Sridharan |
Meenakshi Ammal Dental College |
mennakshi ammal dental college, allapakam main road. janaki nagar. madurovoyal
,chennai, 600095 department of oral maxillofacial surgery
room no:5
Chennai
TAMIL NADU |
9677449227
drgeethaomfs@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical commitee of Meenakshi Ammal Dental College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K011||Impacted teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional suturing techniques |
non resorbable 3-0 silk suture material, braided filament |
| Intervention |
knotless tissue control device |
BARB-E(V-Loc) 3-0 spiral poly(p-dioxanone), unidirectional with end loop , total intervention time for a sample:15 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
patient with nil oral habits, examples: smoking, pan chewing.
patient with co-morbid conditions, example: diabetes, hypertension, bleeding disorders.
patient who require therapeutic removal of third molar. |
|
| ExclusionCriteria |
| Details |
patients with prosthetic valves and stents.
patients with any cysts ,abscess and developmental disorders.
patients on anti-platelet and anti- coagulants.
patients who are pregnant and lactating. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
This study is expected to have an impact on the field of maxillofacial surgery when a new V-Loc knotless wound closure systems proved to be efficient in the terms of infection control rate, wound healing and time taken for wound closure is reduced and less technique sensitive.
to analyze patient comfort and interpret the results and incorporate them in our daily dental practice. |
This study is expected to have an impact on the field of maxillofacial surgery when a new V-Loc knotless wound closure systems proved to be efficient in the terms of infection control rate, wound healing and time taken for wound closure is reduced and less technique sensitive.
to analyze patient comfort and interpret the results and incoporate them in our daily dental practice. With a follow up of baseline ,3 day ,5 day, one week and second week. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
20/04/2024 |
| 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="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
OBJECTIVES:
1. To check the efficacy and feasibility of V-Loc knotless wound closure
systemin the field of maxillofacial surgery.
2.
To compare the potential difference between V-Loc knotless wound
closure system with silk sutures.
3. To compare the wound healing and infection rate between both the
groups. METHEDOLOGY:
This is a split mouth randomised controlled clinical trial to compare the
efficacy of V-Loc knotless wound closure system and silk sutures.Based on
the inclusion criteria patients will be taken into the study. An approximate
of 20 patients will be subjected to the study with orthopantomogram to
confirm and identify bilateral symmetrically impacted third molar teeth,
patients will be divided and allocated to the study and control group
randomly. All the patients will be operated by single surgeon. Patients will
be operated on both sides on the same day under local anaesthesia by
following standard surgical protocol. Wound closure will be done by V-Loc
knotless wound closure system on one side and 3-0 silk sutures on the other
side.Following the procedure patients will be assessed based on these post
operative findings like pain (VAS), swelling (3point value), wound healing
(Laundry’s scale), Maximum inter incisal opening (mouth opening), time
taken to achieve wound closure and haemostasis and rate of infection.
Patients will be reviewed on post operative day 3, 5,7 and 14, values will be
recorded and will be analysed statistically accordingly. INCLUSION CRITERIA:
1.
2.
Subjects between the age group of 18-40 years.
Subjects with nil oral habits (Example: Smoking, Pan chewing)
3. Subjects with no co-morbid conditions (Example: Diabetes, Hypertension
and bleeding disorders etc.)
4.
Subjects who require therapeutic removal of 3" molars. EXCLUSION CRITERIA:
1.
Subjects who are pregnant and lactating.2. Subjects with prosthetic valves and stents.
3. Subjects on anti-platelet and anti-coagulants.
4. Subjects with any cysts, abscess, and or developmental disorders. IMPLICATIONS:
This study is expected to have an impact on the field of maxillofacial surgery
when new V-Loc knotless wound closure system is proved to be efficient in
controlling haemorrhage, infection, enhance wound healing, wound closure
time is reduced and less technique sensitive. To prove the efficiency of V-Loc
knotless wound closure system over silk sutures. |