| 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
|
|
|
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
|
|
|
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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