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CTRI Number  CTRI/2025/06/088312 [Registered on: 05/06/2025] Trial Registered Prospectively
Last Modified On: 04/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Comparing the Germ-Fighting Power of Propolis, Calcium Hydroxide, and Antibiotic Paste in Treating Infected primary Teeth 
Scientific Title of Study   Comparative evaluation of antimicrobial efficacy of Propolis, Calcium hydroxide and Double antibiotic paste as intracanal medicament in primary non vital teeth. 
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 Mohd Abdul Ghani 
Designation  Post graduate student 
Affiliation  Sri Sai college of Dental surgery 
Address  Dept of pedodontics and preventive dentistry 1 2 64 1 2 kothrepally opp shiv sagar lake vikarabad Telangana 501101
1 2 64 1 2 kothrepally opp shiv sagar lake vikarabad Telangana 501101
Hyderabad
TELANGANA
501101
India 
Phone  9959848279  
Fax    
Email  mohdabdulghani81@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Silla Swarna Swathi 
Designation  Professer 
Affiliation  sri sai college of dental surgery 
Address  Dept of pedodontics and preventive dentistry 1 2 64 1 2 kothrepally opp shiv sagar lake vikarabad Telangana 501101
1 2 64 1 2 kothrepally opp shiv sagar lake vikarabad Telangana 501101
Hyderabad
TELANGANA
501101
India 
Phone  9790215500  
Fax    
Email  swathi.swarna18@gmail.com  
 
Details of Contact Person
Public Query  
Name  Silla Swarna Swathi 
Designation  Professer 
Affiliation  sri sai college of dental surgery 
Address  Dept of pedodontics and preventive dentistry 1 2 64 1 2 kothrepally opp shiv sagar lake vikarabad Telangana 501101
1 2 64 1 2 kothrepally opp shiv sagar lake vikarabad Telangana 501101

TELANGANA
501101
India 
Phone  9790215500  
Fax    
Email  swathi.swarna18@gmail.com  
 
Source of Monetary or Material Support  
Dept of pedodontics and preventive dentistry Sri Sai College of Dental Surgery 1 2 64 1 2 kothrepally opp shiv sagar lake vikarabad Telangana 501101 Hyderabad TELANGANA 501101 India  
 
Primary Sponsor  
Name  DR.MOHD ABDUL GHANI 
Address  1 2 64 1 2 kothrepally opp shiv sagar lake vikarabad Telangana 501102 
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 Mohd Abdul Ghani  Sri Sai college of Dental surgery  Room no 9,Dept of pedodontics and preventive dentistry 1 2 64 1 2 kothrepally opp shiv sagar lake vikarabad Telangana 501101 Hyderabad TELANGANA 501101 India
Hyderabad
TELANGANA 		 09959848279

mohdabdulghani81@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE 2022-23 Sri Sai College of Dental surgery  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K041||Necrosis of pulp,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Calcium Hydroxide  calcium Hydroxide powder mixed with propylene glycol into a paste form and placed as an intracanal medicament for one week 
Comparator Agent  Double antibiotic paste  Double antibiotic paste powder is mixed with propylene glycol into a paste form and placed as an intracanal medicament for one week 
Intervention  Propolis   propolis powder mixed with saline into a paste form and placed as an intracanal medicament for one week 
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  Non vital teeth.
Two third of root should be present.
Children with parental consent.
 
 
ExclusionCriteria 
Details  • Teeth with less than two thirds of root.
• Pulpal involvement requiring pulp therapy but not involving the peri radicular tissues.
Teeth with root caries.
Children with systemic illness
Periapical lesions with poor prognosis indicated for extraction
Children without parental consent
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the efficacy of Propolis, Calcium hydroxide and double antibiotic paste as intracanal medicaments.  base line
at one week 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the efficacy of propolis as an intracanal medicament
To evaluate the efficacy of calcium hydroxide as an intracanal medicament
To evaluate the efficacy of double antibiotic paste as an intracanal medicament
 		 the microbial culture will be checked after opening the access cavity & after one week
baseline
after one week 
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
Final Enrollment numbers achieved (Total)= "42"
Final Enrollment numbers achieved (India)="42" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   20/06/2025 
Date of Study Completion (India) 10/07/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 10/07/2025 
Estimated Duration of Trial   Years="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)   Completed 
Recruitment Status of Trial (India)  Completed 
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   Reduction and elimination of the infecting bacteria inside the root canal system plays a key role in success of endodontic therapy.The effectiveness of instrumentation on bacteria in dentinal tubules and lateral canal ramifications is limited which is leading to pulp therapy failure.Intracanal medicaments were introduced for infection control and also to prevent contamination between appointments.The proposed study intends to evaluate beneficial effect of propolis as an intracanal medicament in comparison to calcium hydroxide and double antibiotic paste in primary non vital teeth. 
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