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CTRI Number  CTRI/2025/07/090981 [Registered on: 16/07/2025] Trial Registered Prospectively
Last Modified On: 15/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Using light-activated turmeric and beetroot extract to reduce infection in decayed teeth – A comparison study 
Scientific Title of Study   Comparative evaluation of antimicrobial effectiveness of photodynamic therapy using curcumin and beta vulgaris extract in teeth with periapical pathology :An in vivo 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  Dr Urmy 
Designation  Post graduate student 
Affiliation  Maratha Mandal Nathajirao G Halgekar Institute of Dental Sciences and Research centre 
Address  Department of Conservative dentistry and Endodontics, Department No-6 Maratha Mandal Nathajirao G Halgekar Institute of Dental Sciences and Research centre Bauxite road Near KSRP ground Belagavi

Belgaum
KARNATAKA
590019
India 
Phone  9785638214  
Fax    
Email  urmysinh@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Chetan R Patil 
Designation  Professor 
Affiliation  Maratha Mandal Nathajirao G Halgekar Institute of Dental Sciences and Research centre 
Address  Department of Conservative dentistry and Endodontics Department No-6 Maratha Mandals Nathajirao G Halgekar Institute of Dental Sciences and Research centre Bauxite road Near KSRP ground Belagavi

Belgaum
KARNATAKA
590019
India 
Phone  9448571310  
Fax    
Email  drchetanpatil81@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Chetan R Patil 
Designation  Professor 
Affiliation  Maratha Mandal Nathajirao G Halgekar Institute of Dental Sciences and Research centre 
Address  Department of Conservative dentistry and Endodontics Department No-6 Maratha Mandal Nathajirao G Halgekar Institute of Dental Sciences and Research centre Bauxite road Near KSRP ground Belagavi

Belgaum
KARNATAKA
590019
India 
Phone  9448571310  
Fax    
Email  drchetanpatil81@gmail.com  
 
Source of Monetary or Material Support  
Maratha Mandal Nathajirao G Halgekar Institute of Dental Sciences and Research centre Bauxite road,Near KSRP ground,Belagavi-590019 Karnataka India 
 
Primary Sponsor  
Name  URMY 
Address  Maratha Mandal Nathajirao G Halgekar Institute of Dental Sciences and Research centre BAUXITE ROAD NEAR KSRP GROUND BELAGAVI 
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 URMY  Maratha Mandal Nathajirao G Halgekar Institute of Dental Sciences and Research centre  Department of Conservative dentistry and Endodontics Department number-6
Belgaum
KARNATAKA 
9785638214

urmysinh@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Maratha Mandals Institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  PREVENTING THE WORSENING OF STATUS OF TEETH IN ORAL CAVITY BY PROPER ROOT CANAL TREATMENT ASSISTED BY PHOTODYNAMIC THERAPY 
Patients  (1) ICD-10 Condition: K045||Chronic apical periodontitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Sodium hypochlorite  Biomechanical Preparation (BMP) using sodium hypochlorite ,microbial counts before the application of PDT, act as the within-subject control to assess the additional antimicrobial effect of PDT 
Intervention  curcumin and beta vulgaris  Intervention Group 1: Application of Curcumin solution followed by light activation as PDT in root canal. Intervention Group 2: Application of Beta vulgaris extract followed by light activation as PDT in root canal. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Healthy patients
Single rooted teeth with pulp necrosis and radiographic size of peri apical lesion of diameter 2 to 5 mm.
Potential to achieve canal patency
The candidates ability to understand and provide informed consent
 
 
ExclusionCriteria 
Details  Teeth with incomplete formation of roots
Radiographic size of periapical lesion of diameter geater than 5 mm
Presence of resorption or obliterated root canals and root fractures
Periodontal pockets deeper than 3 mm that is teeth with poor prognosis or any recent history of trauma.
Those teeth from patients who had reported the use of anti inflammatory antibiotics and or immunosuppressive medications within the preceding 14 days for antibiotics and 3 to 5 days for antiinflammatory drugs or any systemic disease were not included in the study.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Reduction in microbial load in root canal samples following photodynamic therapy with Curcumin and Beta vulgaris extract  AFTER 48 HOURS 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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 2 
Date of First Enrollment (India)   05/08/2025 
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 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 - All of the individual participant data collected during the trial, after de-identification.

  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 - Anyone

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

  5. By what mechanism will data be made available?
    Response - Data are available indefinitely at (Link to be included GOOGLE.COM).

  6. For how long will this data be available start date provided 01-03-2026 and end date provided 11-03-2027?
    Response - Immediately following publication. No end date.

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

Need for the study-

 

Despite the promising individual outcomes of curcumin and beetroot as natural photosensitizers  in vitro models there is a lack of comparative in vivo studies evaluating their antimicrobial effectiveness in teeth with periapical pathology. The clinical relevance of these agents in real-time biological environments remains underexplored.

Thus, a study comparing curcumin mediated aPDT and beetroot mediated aPDT following standard chemo mechanical preparation, could provide valuable insight into their relative efficacy biocompatibility and potential as low cost natural alternatives for endodontic disinfection.

This study is a randomized double blind parallel group  single centre trial wherein the effect of photodynamic therapy using curcumin and beet root extract on the microbial load in teeth with periapical pathology is assessed.

Brief summary of the process

METHODOLOGY:

Obtaining the herbal extracts:

The herbal extracts Curcumin and Beta vulgaris will be obtained from AGHP enterprises Chennai India and manufacturer has given authentication certificate for the herbal extracts.

 

Preparation of irrigation solution:

Beta vulgaris and Curcumin will be dissolved in a DMSO to a concentration of 0.5 mg per mL

 

Access opening and Chemomechanical preparation

 

Patients reporting to the department of Conservative Dentistry and Endodontics with complaint of pain will be screened for eligibility after assessing the inclusion and exclusion criteria for this in vivo study .

Healthy patients ,between 18 to 55 years will be shortlisted. The participants will be allotted to  2 different groups by randomization.

After explaining each patient about the study and procedure they will be asked to sign an informed consent form.

After administration of local anaesthesia rubber dam isolation will be obtained access opening will be done and working length will be measured using J morita root ZX 2 PLUS endomotor.The root canal contents  that is dentinal shavings will  be collected  in normal saline in eppendoff tube before  proceeding for chemomechanical preparation.This will be sample 1.

Chemomechanical preparation will be performed with protaper gold of Dentsply til F1 or F2 according to manufacturer’s instructions using 3 percent  NaOCl,saline  and EDTA 17 percent  as irrigating solutions alternatively .Canal instrumentation is either done by crown down or hybrid method depending upon the canal configuration. To neutralize NaoCl the root canal contents will be rinsed with 1 mL 5 percent  sodium thiosulphate and 1 mL of normal saline for 30 seconds. The root canal contents that is dentinal shavings will collected in normal saline  before  proceeding for photodynamic therapy.This will be sample 2.

 

 

Photodynamic therapy

Depending on the group assigned curcumin or beet root photodynamic therapy will be done . The respective photosensitizers will be injected into the root canals and remained for 120 seconds prior to irradiation with Novolase dual wave endo laser. PDT will be carried out for 120 seconds by means of a Novolase dual wave endo laser with a power peak at 640 nm and output intensity of 240 mw per cm square. The irradiation will be  performed using an endodontic tip of 0.5 mm diameter which will be  introduced into the canal up to ½ of the working length.Immediately after photodynamic therapy, the root canals were irrigated with 5mL of sterile saline solution for complete removal of the photosensitizer. The root canal contents that is dentinal shavings will be collected which will be the final sample.This will be sample 3.

 

 

 

Microbiological culture

The shavings that is all the three samples will then be transferred into eppendorf tubes containing 1 ml of normal saline and will be vortexed for 1 minute. The diluted bacterial suspensions will be cultured on Blood  agar plates using the Spread plate technique. After 24 hours of incubation colony forming units  will be counted using a colony counter. The actual bacterial counts will be calculated reported as CFU per mL for each sample .

 


 
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