FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/07/091745 [Registered on: 25/07/2025] Trial Registered Prospectively
Last Modified On: 25/07/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   COMPARATIVE EVALUATION OF THE SUTURELESS AND MULTIPLE SUTURE TECHNIQUE IN THIRD MOLAR IMPACTION: A CLINICAL TRIAL 
Scientific Title of Study   Comparative Evaluation of the Sutureless and Multiple Suture Technique in Third Molar Impaction: A 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  ISHITA RANGNANI 
Designation  POST GRADUATE TRAINEE 
Affiliation  KOTHIWAL DENTAL COLLEGE AND RESEARCH CENTRE 
Address  DEPT OF ORAL AND MAXIILOFACIAL SURGERY, ROOM NO 2
KOTHIWAL DENTAL COLLEGE AND RESEARCH CENTRE
Moradabad
UTTAR PRADESH
244001
India 
Phone  9358837602  
Fax    
Email  ishitarangnani@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  PRANSHU CHAUHAN 
Designation  READER 
Affiliation  KOTHIWAL DENTAL COLLEGE AND RESEARCH CENTRE 
Address  ROOM NO 104, STAFF QUARTERS, KOTHIWAL DENTAL COLLEGE

Moradabad
UTTAR PRADESH
244001
India 
Phone  8077963158  
Fax    
Email  chauhanpranshu@gmail.com  
 
Details of Contact Person
Public Query
 
Name  PRANSHU CHAUHAN 
Designation  READER 
Affiliation  KOTHIWAL DENTAL COLLEGE AND RESEARCH CENTRE 
Address  DEPT OF ORAL AND MAXILLOFACIAL SURGERY, ROOM NO. 2, KOTHIWAL DENTAL COLLEGE


UTTAR PRADESH
244001
India 
Phone  8077963158  
Fax    
Email  chauhanpranshu@gmail.com  
 
Source of Monetary or Material Support  
KOTHIWAL DENTAL COLLEGE, MORADABAD 
 
Primary Sponsor  
Name  ISHITA RANGNANI 
Address  314, Kothiwal Dental College, Moradabad, Uttar Pradesh 244001 
Type of Sponsor  Other [SELF] 
 
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 ISHITA RANGNANI  KOTHIWAL DENTAL COLLEGE  DEPT OF ORAL AND MAXILLOFACIAL SURGERY, ROOM NO. 2
Moradabad
UTTAR PRADESH 
9358837602

ishitarangnani@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS AND REVIEW BOARD  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z40-Z53||Encounters for other specific health care,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Multiple Sutures  Multiple sutures are given in incision site during third molar impaction surgery. 
Intervention  Suture-less technique  No sutures are given in incision site during third molar impaction surgery 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  -American Society of Anaesthesiologists (ASA) physical status I subjects between 20 and 50 years of age, both male and female were included in the study.
-Indications for extraction of a single impacted mandibular third molar under local anaesthesia
-Patients with mesioangular, distoangular, horizontal and vertical impactions according to Winter’s classification
-Absence of symptoms such as facial swelling or limited mouth opening from any cause within 5 days preceding surgery.
 
 
ExclusionCriteria 
Details  - Pregnant females, lactating mothers
- History of allergy to the drugs used in this study.
- Patients not willing for the procedure or not willing to give written informed consent.
- Medically compromised patients.
 
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   Centralized 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Pain  Post-operative day 7 
 
Secondary Outcome  
Outcome  TimePoints 
Pain, Oedema, trismus, complications, flap healing in the experimental arm, analgesic consumption, Quality of life  DAY 0, 7 AND 28 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
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)   15/08/2025 
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="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

Comparative evaluation of the sutureless and multiple suture technique in third molar impaction: a clinical TRIAL

 


One of the most frequent procedures in oral and maxillofacial surgery is the surgical extraction of mandibular third molars. The average incidence of third molar impaction is 24.40% approximately with significant regional variations1. Although environmental characteristics are more likely to be the cause of these differences, genetic factors may play a role. Primary closure of the operating site is usually advocated but is not always essential as advocated by the French Health Authority (HAS)2. There is still debate regarding the optimal surgical methods, particularly with regards to the mucosal closure after surgical removal of impacted mandibular third molar. The two approaches used are to allow for healing by either primary or secondary intention. Suturing of sockets after extraction is recommended by some groups on the grounds that wound approximation help in bleeding control and decreases the contamination of operative site and therefore, enhance the rate and quality of healing. Others, however, favor healing by secondary intention because it allows the surgical site to naturally drain, lowering the risk of inflammatory response. Dubois et al. compared hermetic closure to sites where the mesial portion of the wound was allowed to heal through secondary intention.3

 

On the fifth day, wound dehiscence was noted in fifty percent of the hermetically sutured patients, though no infection was present. They also found that sutured patients had a tendency for incomplete closure, even though there were no changes in postoperative swelling, pain, or infection. Following the extraction of an impacted wisdom tooth, subsequent research has compared surgical site closure methods.4–6. None, however, have assessed quality of life, pain, oedema, trismus, complications, and the use of painkillers after more than seven days following surgery in a sizable cohort. Although the results showed significant heterogeneity because of the variations in the incision techniques used, a meta-analysis of five studies found that secondary closure reduced pain7. There is currently not enough data to determine whether alveolar osteitis, infection, or bleeding responds better to primary or secondary healing.

 

 

 

 

 

 

 

 
Close