| 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
|
|
|
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 |
|
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Regulatory Clearance Status from DCGI
|
|
|
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.
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
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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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Data are available indefinitely at (Link to be included GOOGLE.COM).
- 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.
- 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 . | |