| CTRI Number |
CTRI/2024/08/072720 [Registered on: 20/08/2024] Trial Registered Prospectively |
| Last Modified On: |
12/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study comparing the effectiveness of three biologically compatible materials (Bio-C Repair, NeoPUTTY and Mineral Trioxide Aggregate) for the treatment of milk teeth with serious decay that is close to or affecting the nerve inside but can be saved |
|
Scientific Title of Study
|
Comparative Evaluation of Bio-C Repair, NeoPUTTY and Mineral Trioxide Aggregate as Pulpotomy Agents in primary molars: 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 Nitika Bajaj |
| Designation |
Professor |
| Affiliation |
Baba Farid University of Health Sciences, Faridkot, 151203, Punjab, India |
| Address |
Department Room no 4, Department of Pediatric and Preventive Dentistry, Dasmesh Institute of Research and Dental Sciences, Talwandi road, Faridkot
Faridkot
PUNJAB
151203
India |
| Phone |
9876194481 |
| Fax |
|
| Email |
drnitika_bajaj81@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashita Goyal |
| Designation |
Postgraduate student |
| Affiliation |
Baba Farid University of Health Sciences, Faridkot, 151203, Punjab, India |
| Address |
Department Room no. 4, Department of Pediatric and Preventive Dentistry, Dasmesh Institute of Research and Dental Sciences, Talwandi road, Faridkot
Faridkot
PUNJAB
151203
India |
| Phone |
9914526682 |
| Fax |
|
| Email |
drashitagoyal489@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashita Goyal |
| Designation |
Postgraduate student |
| Affiliation |
Baba Farid University of Health Sciences, Faridkot, 151203, Punjab, India |
| Address |
Department Room no. 4, Department of Pediatric and Preventive Dentistry, Dasmesh Institute of Research and Dental Sciences, Talwandi road, Faridkot
Faridkot
PUNJAB
151203
India |
| Phone |
9914526682 |
| Fax |
|
| Email |
drashitagoyal489@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dasmesh Institute of Research and Dental Sciences, Talwandi Road, Faridkot, 151203, Punjab, India |
|
|
Primary Sponsor
|
| Name |
Dr Ashita Goyal |
| Address |
Dasmesh Institute of Research and Dental Sciences, Talwandi Road, Faridkot, 151203, Punjab, India |
| 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 Ashita Goyal |
Dasmesh Institute of Research and Dental Sciences, talwandi Road, Faridkot, 151203 |
Department room no 4, Department of Pediatric and Preventive Dentistry
Faridkot
PUNJAB |
9914526682
drashitagoyal489@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL REVIEW BOARD |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy pediatric patients aged 4-8 years with carious deciduous molars with caries approaching pulp. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Bio-C Repair |
Bio-C Repair is an established Biomaterial but it has not yet been used as a pulpotomy agent in primary teeth |
| Comparator Agent |
Mineral Trioxide Aggregate |
Mineral Trioxide Aggregate is an established material as a pulpotomy agent and AAPD recommends its use in pediatric molar pulpotomy procedures. |
| Comparator Agent |
NeoPUTTY |
NeoPUTTY is an established material but its studies as a pulpotomy agent in primary molars are limited. |
| Intervention |
Various Biomaterials as pulpotomy agents |
Three biomaterials will be Compared and evaluated for their efficacy based on their clinical and radiographic outcomes as pulpotomy agents in deciduous molars in pediatric patients. |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy and cooperative children in the age group of 4-8 years.
2. No history of spontaneous or persistent pain.
3. Restorable primary molars with deep carious lesions approximating or reaching the pulp.
4. No pain on percussion
5. No pathological mobility
6. No Periodontal ligament widening as seen in the radiograph
7. No pathological internal or external root resorption.
8. No apical or furcal radiolucency.
9. Hemostasis achieved within 5 minutes of coronal pulp amputation.
|
|
| ExclusionCriteria |
| Details |
1. Uncooperative patient.
2. Patients with a history of allergy to local anesthetics.
3. Medically compromised patient.
4. Non-restorable tooth.
5. Tooth with periapical or furcal radiolucency.
6. The tooth with internal or external root resorption.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare and evaluate the efficacy of Bio-C Repair, NeoPUTTY, and Mineral Trioxide Aggregate (MTA) as pulpotomy agents in primary molars. |
at 1, 3, 6 and 9 months post opertaively. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To evaluate the efficacy of Bio-C Repair as a pulpotomy agent in primary molars.
2. To evaluate the efficacy of NeoPUTTY as a pulpotomy agent in primary molars.
3. To evaluate the efficacy of Mineral Trioxide Aggregate (MTA) as a pulpotomy agent in primary molars.
4. To compare the efficacy of Bio-C Repair, NeoPUTTY, & Mineral Trioxide Aggregate (MTA) as pulpotomy agents in primary molars.
|
at 1, 3, 6 & 9 months post opertaively. |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
30/09/2024 |
| 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="6"
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- 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 - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drashitagoyal489@gmail.com].
- For how long will this data be available start date provided 08-09-2025 and end date provided 08-09-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
The selected patients will be randomly assigned to three groups using Research Randomizer (Version 4.0), according to the pulpotomy agent used. Group I – Bio-C Repair will be used as the pulpotomy agent in primary molars. Group II – NeoPUTTY will be used as the pulpotomy agent in primary molars. Group III – Mineral Trioxide Aggregate (MTA) will be used as the pulpotomy agent in primary molars. CLINICAL PROCEDURE Preoperative clinical and radiographic examinations will be done to ensure proper case selection. Local anesthesia will be administered followed by rubber dam isolation. All the carious tissue will be removed and the coronal pulp will be amputated using a sterile sharp spoon excavator or sterile slow-speed round bur until the orifices could be seen. Hemostasis will be achieved with the help of sterile saline moistened cotton pellets. Following hemostasis, the respective group pulpotomy agent will be applied. Group I - Bio-C Repair will be applied directly on the exposed pulp and then will be adapted with a moistened cotton pellet. Group II - NeoPUTTY will be applied directly on the exposed pulp and then will be adapted with a moistened cotton pellet. Group III - MTA will be prepared by mixing MTA powder with distilled water on a sterile mixing glass slab. The mixture will be carried to the pulp chamber and will then be condensed and adapted with the help of a moistened cotton pellet. After the application of the pulpotomy agent, the tooth will be restored with glass ionomer cement followed by the placement of stainless steel crown. Further follow-up visits will be planned at 1, 3, 6, and 9 months for clinical and radiographic analysis based on modified Zurn and Seale’s scoring criteria (Musale and Soni, 2016). |