| CTRI Number |
CTRI/2025/07/090937 [Registered on: 15/07/2025] Trial Registered Prospectively |
| Last Modified On: |
15/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing the Effect of Two obturating materials on Baby Tooth Root Disappearance Using 3D Imaging |
|
Scientific Title of Study
|
A clinical study to evaluate the rate root resorption of the primary molars obturated by combining different materials in different concentrations: a comparative CBCT 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 Tushar Pruthi |
| Designation |
Associate Professor |
| Affiliation |
Subharti dental college and Hospital, Swami vivekanada subharti university |
| Address |
Subharti Dental college and Hospital, Swami vivekanada subharti university
Meerut
UTTAR PRADESH
250005
India |
| Phone |
7015640376 |
| Fax |
|
| Email |
drtusharpruthi7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tushar Pruthi |
| Designation |
Associate Professor |
| Affiliation |
Subharti dental college, Swami vivekanada subharti university |
| Address |
Subharti dental college and hospital,Swami vivekanada subharti university
Meerut
UTTAR PRADESH
250005
India |
| Phone |
7015640376 |
| Fax |
|
| Email |
drtusharpruthi7@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nikhil Srivastava |
| Designation |
Professor |
| Affiliation |
Subharti dental college, Swami vivekanada subharti university |
| Address |
Pediatric and Preventive Dentistry, Swami vivekanada subharti university
Meerut
UTTAR PRADESH
250005
India |
| Phone |
7015640376 |
| Fax |
|
| Email |
drnikhipedo@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Tushar Pruthi Self |
| Address |
Subharti Dental college and Hospital,Swami vivekanada subharti university, meerut, uttar pradesh 250005 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Tushar Pruthi |
Subharti dental college and hospital |
Department of Pediatric and Preventive Dentistry, Subharti dental college and hospital, Swami vivekanada subharti university
Meerut
UTTAR PRADESH |
7015640376
tusharpruthi7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| university ethics committee (Medical) Swami Vivekanda subharti university |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
metapex and Zinc oxide |
The study aims to assess the root resorption rate of primary molars obturated withcombination of two materials in different . concentrations. This call for proposal will give us the capacity for studying the change in commonly used root canal obturating material. The use of CBCT is to find the definitive pattern of the root resorption. This study will allow us to obtain a better root canal obturating material with resorption rate similar to the roots ofprimary teeth. The patient will be followed at 6,12,18 and 24 months. |
| Intervention |
calcium hydroxide and zinc oxide |
The study will delineate the relationship between obturating material and primary teeth resorption. This study will also explain whether combination of ZOE and metapex is a better choice than ZOE and Metapex alone. The patient will be recalled at 6,12,18 and 24 months. |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
7.00 Year(s) |
| Gender |
Both |
| Details |
1. Deep carious lesion with pulp exposure
2. Tooth previously planned for pulpotomy with uncontrollable bleeding lasting for more than 5 mins
3. Carious molar with the history of Spontaneous pain4. Carious molars with Chronic apical abscess or fistula
5. Pulpally exposed tooth with adequate periodontal and bony support
6. Signs of inter-radicular radiolucency 7.Absence of radicular ,dentigerous or follicular cyst |
|
| ExclusionCriteria |
| Details |
1.Non restorable tooth
2. Signs of any internal or external resorption.
3. Root resorption more than 2/3rdof length.
4. Excessive tooth mobility.
5. Presence of pathological cyst in association with the primary teeth.
6. Medically compromised patient. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The study aims to assess the root resorption rate of primary molars obturated with combination of two materials in different concentrations. This call for proposal will give usthe capacity for studying the change in commonly used root canal obturating material. Theuse of CBCT is to find the definitive pattern of the root resorption. This study will allow usto obtain a better root canal obturating material with resorption rate similar to the roots ofprimary teeth. |
6,12,18 and 24 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Combination of ZOE and Metapex with different concentration will have a promising result.The experimental (intervention) group as compared to the control group will have morefavourable resorption rate. Key Question Do the combination of ZOE and Metapex with different concentrations have resorption rate similar to physiologic resorption of primary teeth |
3 years |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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
|
N/A |
|
Date of First Enrollment (India)
|
30/07/2025 |
| 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="3"
Months="0"
Days="30" |
|
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
|
Success of pulpectomy is directly dependant on several factors including total disinfection and a fluid tight seal along the length of the root canal system from coronal opening to the apical end. This can be achieved by careful cleaning and shaping, followed by complete obturation of the canal space. An ideal obturating material to be used in primary teeth should have antibacterial property, resorbable with its resorption rate comparable with the roots, radiopaque and harmless to the developing tooth bud. Though, no available material fulfils all these criteria , Zinc oxide Euginol (ZOE) is the traditional and the most commonly used obturating material. In spite of its antibacterial property and high success rate, its resorption rate is slower than the primary roots. Also, when extruded, it takes months or even years to resorb and may deflect the erupting tooth. Combination of Iodoform and Calcium Hydroxide, commercially available as Metapex is another routinely used obturating material. It is potent bactericidal, radiopaque, non-shrinking and non-soluble material but its resorption rate is faster than the root leading to the “Hallow-Tube effect. The study aims to assess the root resorption rate of primary molars obturated with combination of two materials in different concentrations. This call for proposal will give us the capacity for studying the change in commonly used root canal obturating material. The use of CBCT is to find the definitive pattern of the root resorption. This study will allow us to obtain a better root canal obturating material with resorption rate similar to the roots of primary teeth. |