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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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 : 

 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. 

 
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