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CTRI Number  CTRI/2024/10/074958 [Registered on: 08/10/2024] Trial Registered Prospectively
Last Modified On: 25/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia
Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of the healing of wound after removal of impacted lower wisdom tooth with and without stitching .  
Scientific Title of Study   Comparative evaluation of the healing of extraction socket with and without suture after removal of impacted mandibular third molars-A Randomised clinical trial.  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
drchandansingh  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Chandan Singh 
Designation  MDS Student 
Affiliation  Rungta College of Dental Sciences and Research Bhilai CG 
Address  HN 22 block A Govt dental college campus Rajbandha maidan Raipur CG
Department of oral and maxillofacial surgery Rungta College of Dental Sciences and Research Bhilai CG
Raipur
CHHATTISGARH
492001
India 
Phone  9907276363  
Fax    
Email  drchandansingh1307@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sruthi Rao 
Designation  Professor & HOD 
Affiliation  Rungta College of Dental Sciences and Research Bhilai CG 
Address  Department of oral and maxillofacial surgery Rungta College of Dental Sciences and Research Bhilai CG

Durg
CHHATTISGARH
490024
India 
Phone  8518882523  
Fax    
Email  shrusurg@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sruthi Rao 
Designation  Professor & HOD 
Affiliation  Rungta College of Dental Sciences and Research Bhilai CG 
Address  Department of oral and maxillofacial surgery Rungta College of Dental Sciences and Research Bhilai CG


CHHATTISGARH
490024
India 
Phone  8518882523  
Fax    
Email  shrusurg@gmail.com  
 
Source of Monetary or Material Support  
Rungta college of dental sciences and research kohka Bhilai CG India 490024 
 
Primary Sponsor  
Name  Dr Chandan Singh 
Address  Rungta college of dental sciences and research kohka Bhilai CG india 490024 
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 Chandan Singh  Rungta college of dental sciences and research Bhilai CG   room no 3 Department of oral and maxillofacial surgery
Durg
CHHATTISGARH 
9907276363

drchandansingh1307@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee Rungta college of dental sciences and research Bhilai CG  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K01||Embedded and impacted teeth,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  with suture  Third molar surgical extraction with suture placement placement conventional triangular incision will be placed mucoperiosteal flap will be elevated buccal and distal guttering will be done tooth sectioning will be done if needed tooth will be elevated and suture will be placed  
Intervention  without suture  Third molar surgical extraction without silk suture placement conventional triangular incision will be placed mucoperiosteal flap will be elevated buccal and distal guttering will be done tooth sectioning will be done if needed tooth will be elevated and suture will not be placed  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  1. ASA Class I patients.
2. Patients between the ages of 18 – 40 years.
3. Patients with impacted mandibular third molar.
4. Asymptomatic at the time of surgery.
 
 
ExclusionCriteria 
Details  1. Patients allergic to local anesthetics
2. Pregnant or lactating mother
3. Patients with systemic diseases.
4. Presence of acute infections / swelling / pathology in oral cavity at the time of surgery.
5. Patients taking medication that could interfere with healing after surgery.
6. Intellectually and developmentally disabled patients.
7. Patients with poor oral hygiene or periodontally compromised patients.
8. Smokers.

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Healing  post op day 1,2,7 
 
Secondary Outcome  
Outcome  TimePoints 
pain,trismus,facial swelling  post op day 1,2,7 
 
Target Sample Size   Total Sample Size="62"
Sample Size from India="62" 
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)   10/10/2024 
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="6"
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  

NEED FOR THE STUDY:

 

The removal of an impacted third molar is the most common surgical procedure performed by oral surgeons 1. These teeth generally erupt between the ages of 17 and 21 years. It has also been reported that the third molar eruption varies with races, such as in Nigeria mandibular third molars may erupt as early as 14 years and in Europe it may erupt up to the age of 26 years. Factors such as the nature of the diet that may lead to attrition, reduced mesiodistal crown diameter, degree of use of the masticatory apparatus and genetic inheritance also affect the timing of third molar eruption2.

Impacted tooth is defined as a tooth that is prevented from erupting into position  within the expected time  due to a physical barrier within the path of eruption . 3rd molar impactions are associated with several acute or chronic pathological changes, such as pain, infection, caries, periodontal disease, root resorption, bone loss, cyst formation, and benign tumors, justifying its removal. Pain, swelling, decreased mouth opening and temporary inability to work are the generally accepted inevitable postoperative consequences following surgical extraction. This is further associated with a significant deterioration in oral health related quality of life in the immediate postoperative period  and an increase in the total expenditure for removal of third molars 3.

One of the factors most closely linked to the intensity of post-operative pain and swelling is the type of healing of the surgical wound. In secondary healing, the socket remains in communication with the oral cavity; in primary healing, the socket is covered and sealed hermetically by a mucosa flap4. Damage to the capillary vessels and the release of inflammatory cytokines as a result of the trauma lead to increased permeability of vessels, which results in accumulation of serosanguinous fluid and exudates.5

Conflicting opinions have been expressed in the literature concerning these two types of healing. Some authors are in favour of closed healing, whereas other authors report that primary healing frequently causes greater pain and swelling than secondary healing. Other authors are of the opinion that postoperative progress does not differ in the two types of healing 4.

The present study is intended to compare the pain , swelling , trismus and healing of extraction socket with suture and without suture   after  removal of impacted mandibular third  molar .

 
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