| CTRI Number |
CTRI/2025/02/080051 [Registered on: 07/02/2025] Trial Registered Prospectively |
| Last Modified On: |
04/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Suture less surgical extraction of impacted mandibular third molar |
|
Scientific Title of Study
|
Comparative evaluation of suture versus suture-less procedures in impacted mandibular third molar extraction: A Randomized Controlled 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 |
Akash Mandal |
| Designation |
Post Graduate Student |
| Affiliation |
KAHER KLE Vishwanath Katti Institute of Dental Sciences |
| Address |
Department of Oral and Maxillofacial surgery ,KAHER KLE Vishwanath Katti Institute of Dental Sciences, JNMC Campus, Nehru Nagar Belgaum KARNATAKA 590010 India |
| Phone |
08240927067 |
| Fax |
|
| Email |
akashmandal0397@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Akash Mandal |
| Designation |
Post Graduate Student |
| Affiliation |
KAHER KLE Vishwanath Katti Institute of Dental Sciences |
| Address |
Department of Oral and Maxillofacial surgery ,KAHER KLE Vishwanath Katti Institute of Dental Sciences, JNMC Campus, Nehru Nagar Belgaum KARNATAKA 590010 India |
| Phone |
08240927067 |
| Fax |
|
| Email |
akashmandal0397@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Sanjay S Rao |
| Designation |
PROFESSOR |
| Affiliation |
KAHER KLE Vishwanath Katti Institute of Dental Sciences |
| Address |
Department of Oral and Maxillofacial surgery ,KAHER KLE
Belgaum KARNATAKA 590010 India |
| Phone |
09845454266 |
| Fax |
|
| Email |
sanjsamuel@yahoo.com |
|
|
Source of Monetary or Material Support
|
| KAHER KLE Vishwanath Katti Institute of Dental Sciences, JNMC Campus, Nehru Nagar, Belagavi, 590010, Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Akash Mandal |
| Address |
Department of Oral and Maxillofacial surgery ,KAHER KLE
Vishwanath Katti Institute of Dental Sciences, JNMC Campus, Nehru Nagar
Belgaum
KARNATAKA
590010
India |
| Type of Sponsor |
Other [self-funded] |
|
|
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 Akash Mandal |
KAHER KLE Vishwanath Katti Institute of Dental Sciences, JNMC Campus |
Department of Oral and Maxillofacial surgery ,KAHER KLE
Vishwanath Katti Institute of Dental Sciences, JNMC Campus, Nehru Nagar
Belgaum
KARNATAKA
590010
India Belgaum KARNATAKA |
08240927067
akashmandal0397@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Research and Ethics Committee KLE VKIDS |
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 |
Control group(sutureless) |
The operated site for surgical removal of impacted mandibular third molar receives suturing for primary closure. Observation of swelling should be done at day 0, day 3 and day 5. |
| Intervention |
Study group (sutureless) |
The operated site for surgical removal of impacted mandibular third molar is kept suture-less post-operatively. Observation of swelling should be done at day 0, day 3 and day 5. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
52.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients aged 20 – 52 years.
2.Impacted mandibular third molar (mesioangular, vertical.)
3.Patient who give consent for the following treatment. |
|
| ExclusionCriteria |
| Details |
sion criteria :
1.Patient who are affected by systemic illness.
2.Patients who are immunocompromised.
3.Patient who did not give the consent for following treatment.
4.Patients with history of chemotherapy and radiotherapy.
5.Patients with infectious third molar/wound (pericoronitis/infected) |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the post-operative swelling, bleeding and discomfort of the patient in suture-less surgical procedure against sutured surgical procedure in disimpaction of mandibular third molar surgery. |
To evaluate the post-operative swelling, bleeding and discomfort of the patient in suture-less surgical procedure against sutured surgical procedure in disimpaction of mandibular third molar surgery at day 0, day 3 and day 5. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the post-operative bleeding & discomfort of the patient in suture-less surgical procedure against sutured surgical procedure in disimpaction of mandibular third molar surgery. |
To evaluate the post-operative bleeding & discomfort of the patient in suture-less surgical procedure against sutured surgical procedure in disimpaction of mandibular third molar surgery at day 0, day 3 & day 5 |
|
|
Target Sample Size
|
Total Sample Size="42" Sample Size from India="42"
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 3 |
|
Date of First Enrollment (India)
|
18/02/2025 |
| 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="8" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
The extraction of impacted third molars through surgery is a frequently performed procedure that encompasses various methods and subjective viewpoints. Many practitioners concur that the duration of the surgery, degree of trauma, and level of complexity significantly influence complications after the operation. The primary goal of the surgery is to efficiently and meticulously extract the impacted tooth while minimizing complications. Throughout time, there have been differing perspectives on the techniques of primary and secondary wound closure. The surgical approach for the removal of lower third molars is different as the reflection of soft tissues and the amount of bone removed is substantially greater than other surgical tooth extractions The primary closure of a third molar flap is based on fundamental surgical principles and endorsed by Howe, Archer, Guralnick, Kruger, Waite, Thoma, Killey, and Peterson.(1) Conversely, secondary intention is advocated by other authors like Hunter, Bourgoyne, Blair, Ivey, Padgett, and Mead to enhance irrigation and drainage. Dubois reported a comparison of primary and secondary closure techniques after removal of impacted mandibular third molars in 46 patients but the differences were insignificant.(1) The purpose of this study is to report the surgical outcomes of one surgeons standard third molar procedure and compare the results with the results of surgical procedures involving placement of sutures for disimpaction of mandibular third molars. Aim of the study : To evaluate the efficacy of suture-less surgical procedure against sutured surgical procedure in disimpaction of mandibular third molar surgery. Objective : l To evaluate the post-operative swelling, bleeding and discomfort of the patient in suture-less surgical procedure against sutured surgical procedure in disimpaction of mandibular third molar surgery. |