| CTRI Number |
CTRI/2025/05/087638 [Registered on: 26/05/2025] Trial Registered Prospectively |
| Last Modified On: |
13/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study comparing two different filling materials used in baby teeth after root canal treatment over a period of 12 months |
|
Scientific Title of Study
|
Clinical And Radiographical Assessment Of Endoflas+ Eugenol And
Endoflas+Propolis As Obturating Material In Primary Molars A 12 Months
Follow Up Study |
| Trial Acronym |
nill |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Poorav Pankaj Kumar Patel |
| Designation |
MDS student |
| Affiliation |
Government Dental College and Hospital Ahmedabad |
| Address |
Government Dental College and Hospital Civil hospital campus Asarwa Ahmedabad.
Ahmadabad
GUJARAT
380016
India |
| Phone |
8200775928 |
| Fax |
|
| Email |
pooravpatel11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Shantanu Choudhari |
| Designation |
Head of Department |
| Affiliation |
Government Dental College and Hospital Ahmedabad |
| Address |
Department of Pedodontia and Preventive Dentistry
Government Dental College and Hospital Civil hospital campus Asarwa Ahmedabad.
Ahmadabad
GUJARAT
380016
India |
| Phone |
9825666575 |
| Fax |
|
| Email |
shandent1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Poorav Pankaj Kumar Patel |
| Designation |
MDS student |
| Affiliation |
Government Dental College and Hospital Ahmedabad. |
| Address |
Government Dental College and Hospital Civil hospital campus Asarwa Ahmedabad.
Ahmadabad
GUJARAT
380016
India |
| Phone |
8200775928 |
| Fax |
|
| Email |
pooravpatel11@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Dental College and Hospital Civil Hospital Campus Asarwa Ahmedabad 380016 |
|
|
Primary Sponsor
|
| Name |
Ahmedabad Dental Corporation |
| Address |
Sparsh Complex Basement, 100FT. Road, near Indian Oil Petrol Pump. Opp. Gate No.4, Civil Hospital, Asarwa, Ahmedabad 380016 |
| Type of Sponsor |
Other [Ahmedabad Dental Corporation] |
|
|
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 Poorav Pankaj Kumar Patel |
Government Dental College and Hospital Ahmedabad. |
Room number:305, 5th Floor Department of Pedodontia and Preventive Dentistry.
Ahmadabad
GUJARAT |
08200775928
pooravpatel11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Government Dental College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K044||Acute apical periodontitis of pulpal origin, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group1- Endoflas combined with eugenol
Group2- Endoflas combined with propolis |
-To assess clinical efficacy of Endoflas+Propolis and Endoflas+Eugenol as obturating material
-To assess radiographic efficacy of Endoflas+Propolis and Endoflas+Eugenol as obturating material
-To assess the benefit of adding Propolis to the Obturating material
|
| Intervention |
To evaluate clinically and radiographically the effectiveness of Endoflas with Propolis and Endoflas with Eugenol as an obturating material in Primary Molars. |
children aged 4-9 years requiring pulpectomy as a treatment will be selected. They were divided into 2 groups according to the obturating material- Endoflas with proplis and endoflas with eugenol. |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
Patients with Frankl behavior scores of 3 (positive) and 4 (definitely positive) are cooperative and suitable for dental procedures like pulpectomy. Treatment is considered when at least two-thirds of the root length remains and there is enough tooth structure to place a rubber dam clamp. Primary molars diagnosed with chronic irreversible pulpitis meet the clinical criteria for pulpectomy. |
|
| ExclusionCriteria |
| Details |
Patients with a diagnosed systemic disease.
2. Patients showing disruptive behavior during the procedure.
3.Patients with non-restorable teeth clinically, pulpal floor perforation, excessive mobility.
4. Presence of frank dentoalveolar abscess or extra-oral swelling (presence of purulence in the canals).
5. Patients with more than one-third of pathologic root resorption.
|
|
|
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 |
| This study is aimed to access the compatibility of propolis with Endoflas and clinical parameters of this combination may prove better than conventional method, after 12 months follow up period |
Baseline, 3 months, 6 months and 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
10/06/2025 |
| 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 Yet Recruiting |
| 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
|
Primary
tooth itself is the best space maintainer. Pulpectomies of primary teeth with
severe pulpal involvement should be considered as the treatment of choice. Pulpectomy is a customary practice in children with
pulpal and periapical infection which requires thorough elimination of bacteria
from the root canals.
Propolis,
a natural product with Anti-bacterial and Anti-inflammatory properties when
mixed with Endoflas powder as root canal filling material could provide good
success in endodontic therapy of primary teeth. So, the aim of the study is to
evaluate clinically and radiographically the effectiveness of Endoflas with
Propolis and Endoflas with Eugenol as an obturating material in Primary Molars. |