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CTRI Number  CTRI/2024/05/066793 [Registered on: 06/05/2024] Trial Registered Prospectively
Last Modified On: 20/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A CLINICAL TRIAL TO EVALUATE THIRD MOLAR EXTRACTION SOCKET HEALING WITH OR WITHOUT TURMERIC PLACED IN THEM 
Scientific Title of Study   EFFICACY OF CURCUMIN (CURCUMA LONGA) AS AN ADJUVANT THERAPEUTIC AGENT AFTER SURGICAL REMOVAL OF IMPACTED MANDIBULAR THIRD MOLAR. A SPLIT MOUTH STUDY 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Spoorthi Prabhu 
Designation  Post Graduate  
Affiliation  Rajarajeswari dental college and hospital  
Address  Room no 3,department of oral and maxillofacial surgery Rajarajeswari dental college and hospital Kumbalgodu Mysore Road Bangalore KARNATAKA 560074 India

Bangalore
KARNATAKA
560074
India 
Phone  09164466798  
Fax    
Email  spoorthiprabhu29@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Rohit S 
Designation  Professor 
Affiliation  Rajarajeswari dental college and hospital  
Address  Room no:3,Dept of oral and maxillofacial surgery Rajarajeswari Dental College and Hospital No.14 Ramohalli ,Mysore road Bangalore

Bangalore
KARNATAKA
560074
India 
Phone  9845439046  
Fax    
Email  rohit.srikanthan@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr spoorthi  
Designation  Post Graduate  
Affiliation  Rajarajeswari dental college and hospital  
Address  Room no:3,Dept of oral and maxillofacial surgery Rajarajeswari Dental College and Hospital No.14 Ramohalli ,Mysore road Bangalore

Bangalore
KARNATAKA
560074
India 
Phone  9164466798  
Fax    
Email  spoorthiprabhu29@gmail.com  
 
Source of Monetary or Material Support  
Rajarajeswari dental college and hospital  
 
Primary Sponsor  
Name  Dr Spoorthi T S 
Address  Room no:3,Dept of oral and maxillofacial surgery Rajarajeswari Dental College and Hospital No.14 Ramohalli ,Mysore road Bangalore 
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 SPOORTHI T S  Rajarajeswari dental college and hospital   room no3,dept of oral and maxillofacial surgery
Bangalore
KARNATAKA 		 09164466798

spoorthiprabhu29@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE RAJARAJESWARI DENTAL COLLEGE AND HOSPITAL  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K011||Impacted teeth. Ayurveda Condition: IKSHUVALIKAMEHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator Arm (Non Ayurveda)-Normal healingno intervention in the comparator site and its allowed to heal on its own
2Intervention ArmDrugClassical(1) Medicine Name: curcumin, Reference: curcumin longa, Route: Topical, Dosage Form: Churna/ Powder, Dose: 250(mg), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 1 Weeks, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Patients aged between 18-65 years with similar impacted bilateral mandibular third molars undergoing extractions at two different intervals.
2.Patients classified under ASA I and ASA II requiring surgical extraction of similar impacted bilateral mandibular third molars
3.Selected patients will be non-smokers.
 
 
ExclusionCriteria 
Details  1.Patients with poor oral hygiene.
2.Diseases of oral mucosa.
3.Patients with history of radiation therapy
4.Pregnant patients.
5.Patients with psychiatric illness.
6.Patients classified under ASA III and ASA IV.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Centralized 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
1)pain assessment
2)oedema assessment
3)soft tissue healing
4)maximal interincisal opening 		 1)pain assessment on 3rd and 7th day
2)oedema assessment on 3rd and 7th day
3)soft tissue healing (3rd,7th,14th,21st days)
4)maximal interincisal opening(3rd and 7th day) 
 
Secondary Outcome  
Outcome  TimePoints 
alveolar osteitis  7days 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   15/05/2024 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [spoorthiprabhu29@gmail.com].

  6. For how long will this data be available start date provided 20-01-2024 and end date provided 20-01-2029?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

      A total no. of 40 participants to be recruited in the study . Each patient will sign an informed consent form after receiving a thorough explanation regarding

       the  study. The patients requiring  surgical removal of similar impacted bilateral mandibular third molars

        will be chosen as per inclusion and exclusion criteria as the study subjects.

        Surgical site will be randomly divided into two groups-Group A and Group B

        Group A-Surgical site where crushed curcumin tablet(250mg) will be placed (Study group).

        Group B-Surgical site which will undergo natural healing (Control group).  
After intervention in the groups. the following parameters are assessed

·       Pain assessment: : Pain intensity will be assessed using a 10-point Numerical rating scale of score ranging from “0” no pain to severe/unbearable pain “10”. The severity of pain will be evaluated postoperatively after 3days  and 1 week.

·       Soft tissue healing assessment: Soft tissue healing will be assessed by colour of gingiva, bleeding on palpation, epithelization of margins and presence of suppuration. The quality of soft tissue healing will be clinically evaluated at 3, 7, 14 and 21 days postoperatively using Healing Index modified .

·       For the assessment of Oedema: On 3rd and 7thday post-operatively, according to the study done by Kocer et al , oedema is  evaluated using three facial lines

·        (1) the distance from external canthus of the eye to the gonion angle (LC-Go)

        (2) the distance from lower border of the tragus to the mouth commissure on the operated

          side (Tr-C)

        (3) the distance from lower border of the tragus to the soft pogonion (Tr-Pog)

For the assessment of Maximal inter-incisal opening: pre and post operative maximal inter-incisal opening (MIO) measurements are recorded on 3rd and 7th day using a Vernier caliper
 
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