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CTRI Number  CTRI/2025/06/089611 [Registered on: 26/06/2025] Trial Registered Prospectively
Last Modified On: 05/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Clinical and radiographical evaluation of pulpectomies obturating material with and without neem gel in deciduous molar 
Scientific Title of Study   Comparative clinical and radiographical evaluation of Pulpectomies using obturating material with and without neem Gel in primary molars: split-mouth randomized controlled trial 
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 Mahesh Dadpe 
Designation  Professor And HOD 
Affiliation  Maharashtra Institute of Dental Sciences and Research dental college Latur 
Address  Room No.6,Ground Floor, Department of Pediatric and Preventive Dentistry, Maharashtra Institute of Dental Sciences and Research dental college Latur, MAHARASHTRA 413512 Latur

Latur
MAHARASHTRA
413512
India 
Phone  9823733222  
Fax    
Email  drmaheshdadpe@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shreya Avinash Puri 
Designation  Post graduate student 
Affiliation  MIDSR Dental College, Latur, Maharashtra 
Address  Room No.6,Ground Floor, Department of Pediatric and Preventive Dentistry, Maharashtra Institute of Dental Sciences and Research dental college Latur, MAHARASHTRA 413512 Latur

Latur
MAHARASHTRA
413512
India 
Phone  9890012056  
Fax    
Email  shreya07puri@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shreya Avinash Puri 
Designation  Post graduate student 
Affiliation  MIDSR Dental College, Latur, Maharashtra 
Address  Room No.6,Ground Floor, Department of Pediatric and Preventive Dentistry, Maharashtra Institute of Dental Sciences and Research dental college Latur, MAHARASHTRA 413512 Latur

Latur
MAHARASHTRA
413512
India 
Phone  9890012056  
Fax    
Email  shreya07puri@gmail.com  
 
Source of Monetary or Material Support  
Room No.6,Ground Floor, Department of Pediatric and Preventive Dentistry, Maharashtra Institute of Dental Sciences and Research dental college Latur, MAHARASHTRA 413512 Latur 
 
Primary Sponsor  
Name  Shreya Avinash Puri 
Address  Room No.6,Ground Floor, Department of Pediatric and Preventive Dentistry, Maharashtra Institute of Dental Sciences and Research dental college Latur, MAHARASHTRA 413512 Latur 
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 
Shreya Puri  Maharashtra Institute of Dental Sciences and Research  Room no. 6, Department of Pediatric And Preventive Dentistry, MIDSR Dental College, Latur, Maharashtra 413512
Latur
MAHARASHTRA 
9890012056

Shreya07puri@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics committee MIDSR Dental College, Latur, Maharashtra  Approved 
Maharashtra University Of Health Sciences, Nashik  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Young cooperative patients aged 3–8 years. Children with complaints of pain in pulpally involving primary molars. Children requiring pulpectomy treatment  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Endoflas  Primary molar obturation using endoflas.Clinical and radiographical evaluation of obturation at 3, 6, and 12-month intervals. 
Intervention  Endoflas with neem gel  Primary molar obturation using Endoflas with neem gel. Clinical and radiographical evaluation of obturation at 3, 6, and 12-month intervals. 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  8.00 Year(s)
Gender  Female 
Details  1. Young cooperative patients aged 3–8 years.
2. Children with complaints of pain in pulpally involving primary molars.
3. Primary molars having a minimum of 2/3rd of remaining root length.
4. Restorable tooth structure. 
 
ExclusionCriteria 
Details  1. Children with special healthcare needs or systemic diseases.
2. Presence of internal or external root resorption.
3. Increased mobility other than physiological mobility.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Clinical and radiographical evaluation of Endoflas with neem gel and Endoflas as obturating materials in primary molars.  12 Months 
 
Secondary Outcome  
Outcome  TimePoints 
Compare the quality of obturation using Endoflas with neem gel and Endoflas as obturating materials in primary molars.
 
12 Months 
 
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 4 
Date of First Enrollment (India)   07/07/2025 
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="1"
Months="0"
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   Title: COMPARATIVE CLINICAL AND RADIOGRAPHICAL EVALUATION OF PULPECTOMIES USING OBTURATING MATERIAL WITH AND WITHOUT NEEM GEL IN PRIMARY MOLARS: SPLIT-MOUTH RANDOMIZED CONTROLLED TRIAL

Preservation of the primary tooth in its healthy state should be the goal of every pediatric dentist. Primary teeth are considered the best space maintainers hence, they should be retained for a longer duration to maintain their functions. Reversible pulpitis in primary teeth is treated with vital pulp therapy. Pulpectomy is one of the preferred treatment modalities indicated in teeth with pulpal necrosis, chronic pulpitis, and accidental exposure of the pulp. It is a more conservative approach to prevent the premature loss of primary teeth. The success of the pulpectomy depends on adequate access, cleaning and shaping, and good quality obturation. In deciduous teeth, materials having antimicrobial, resorbability, noninflammatory and nonirritating, and radiopacity for visualization on radiograph qualities are widely utilized as root canal filling materials to increase the likelihood that the endodontic treatment will be successful.
Endoflas is a material that encompasses the desirable properties of  zinc oxide eugenol, calcium hydroxide, and iodoform. It is hydrophilic, firmly adheres to the surface of the root canal walls, and has the ability to disinfect the dentinal tubule. Endoflas is associated with certain disadvantages, like periapical irritation and tooth discoloration, due to the presence of eugenol as a component.
To overcome these disadvantages of the currently available primary root canal obturating materials, there is a continued interest in the search for chemical compounds with broader and more effective antibacterial action and less cytotoxicity.
Herbal products are gaining popularity in dentistry due to their biocompatibility, higher antimicrobial activity, and antioxidant and anti-inflammatory properties.
One such ancient herb that has received enormous scientific attention is Azadirachta indicia A. Juss (A. indica), commonly known as Neem, which has attracted worldwide importance in recent years. It has a wide range of medicinal properties, like, anti-bacterial, anti-fungal, anti-viral, anti-oxidant, anti-ulcer, and anti-inflammatory.
Therefore, this current study is designed to compare the clinical and radiographic success of Endoflas with neem gel and Endoflas as an obturating material in primary molars.

 



 
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