| CTRI Number |
CTRI/2024/10/074844 [Registered on: 07/10/2024] Trial Registered Prospectively |
| Last Modified On: |
07/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Clinical and X-ray Evaluation of Three Different Materials for Treating Tooth Decay in Primary Molars: A Study in Children |
|
Scientific Title of Study
|
Clinical and Radiographic Evaluation Of Three Different Indirect Pulp capping Materials in Primary Molars: A Randomized Clinical 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 |
Bhawana Kumari |
| Designation |
Junior Resident |
| Affiliation |
KING GEORGES MEDICAL UNIVERSITY |
| Address |
Department of Paediatric and Preventive Dentistry King Georges Medical University Shah Mina Road Chowk Lucknow
1020 New TG Hostel King Georges Medical University Khadra Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
8971612842 |
| Fax |
|
| Email |
bhawnasingh2197@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rajeev Kumar Singh |
| Designation |
HEAD OF DEPARTMENT OF PAEDIATRIC AND PREVENTIVE DENTISTRY |
| Affiliation |
KING GEORGES MEDICAL UNIVERSITY |
| Address |
Department of Paediatric and Preventive Dentistry King Georges Medical University Shah Mina Road Chowk Lucknow
Department of Paediatric and Preventive Dentistry King Georges Medical University Shah Mina Road Chowk Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9450849528 |
| Fax |
|
| Email |
rajkids2000@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Bhawana Kumari |
| Designation |
Junior Resident |
| Affiliation |
KING GEORGES MEDICAL UNIVERSITY |
| Address |
Department of Paediatric and Preventive Dentistry King Georges Medical University Shah Mina Road Chowk Lucknow
1020 New TG Hostel King Georges Medical University Khadra Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
8971612842 |
| Fax |
|
| Email |
bhawnasingh2197@gmail.com |
|
|
Source of Monetary or Material Support
|
| self-funded by the investigator, with no external funding sources involved |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| 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 |
| BHAWANA KUMARI |
KING GEORGES MEDICAL UNIVERSITY |
4TH FLOOR NEW DENTAL BUILDING DEPARTMENT OF PAEDIATRIC AND PREVENTIVE DENTISTRY PG CLINIC KGMU LUCKNOW
Lucknow
UTTAR PRADESH |
8971612842
bhawnasingh2197@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| King Georges Medical University U.P., Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Vital dental pulp status in deep carious lesions requiring indirect pulp capping |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ACTIVA BioACTIVE |
ACTIVA BioACTIVE contain rubberized resin and a bioactive ionomer glass. The material has properties of RMGIC combined with modified resin matrix. Dose/Quantity: Sufficient amount to cover the affected dentin.
Frequency: Single application.
Route of Administration: Applied directly over the affected dentin in the prepared cavity of primary molars.
Total Duration: Single application followed by permanent restoration. Clinical and radiographic follow-up will be conducted at 3, 6, 9, and 12 months
|
| Comparator Agent |
Calcium hydroxide (Dycal) |
calcium hydroxide promote dentin bridge formation and pulp healing by releasing calcium ions.
Dose/Quantity: Sufficient amount to cover the affected dentin.
Frequency: Single application.
Route of Administration: Applied directly over the affected dentin in the prepared cavity of primary molars.
Total Duration: Single application followed by permanent restoration. Clinical and radiographic follow-up will be conducted at 3, 6, 9, and 12 months
|
| Intervention |
EndoSequence root repair material (ERRM) |
EndoSequence root repair material (ERRM) is a calcium silicate based cement, available in premixed putty form.
Dose/Quantity: Sufficient amount to cover the affected dentin.
Frequency: Single application.
Route of Administration: Applied directly over the affected dentin in the prepared cavity of primary molars.
Total Duration: Single application followed by permanent restoration. Clinical and radiographic follow-up will be conducted at 3, 6, 9, and 12 months
|
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
1.Cooperative patients with FRANKL rating 3 and 4.
2.Restorable first or second primary molar (maxillary or mandibular molar) with deep occlusal carious lesions involving approximately 3/4th of the dentin.
3.Teeth with signs of reversible pulpitis
4.No history of spontaneous pain, tenderness to percussion, abscess or fistula.
5.Absence of clinical and radiographical pulp involvement
6.Extension of caries such that it has potential to expose the pulp if removed completely
7.Teeth with the absence of pathological root resorption or periapical or furcal radiolucency
8.Teeth with less than one-third physiological root resorption
|
|
| ExclusionCriteria |
| Details |
1.Medically compromised patients
2.Uncooperative patients with FRANKL scale less than 3
3.Teeth with history of night pain, abscess, swelling and tenderness.
4.Teeth with clinical or radiographic involvement of pulp
5.Teeth with periapical or furcal radiolucency
6.Patients who decline to participate
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Preservation of pulp vitality assessed through clinical and radiographic evaluations (absence of symptoms such as pain, swelling, or signs of infection, and no radiographic evidence of periapical pathology or internal resorption
post operative pain (VAS)
|
3, 6, 9, 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Restorative material integrity (USPHS criteria)
|
3, 6, 9, 12 months |
|
|
Target Sample Size
|
Total Sample Size="79"
Sample Size from India="79"
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 |
|
Date of First Enrollment (India)
|
20/10/2024 |
| 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 - NO
|
|
Brief Summary
|
Various materials have been used for indirect pulp capping, with calcium hydroxide as the gold standard. However, its limitations have led to the exploration of alternatives like EndoSequence root repair material (ERRM) and ACTIVA BioACTIVE, which aim to promote pulp healing while addressing the drawbacks of calcium hydroxide. ERRM is a calcium silicate-based cement, while ACTIVA BioACTIVE combines the properties of resin-modified glass ionomer cement (RMGIC) with a modified resin matrix. These materials release beneficial ions for pulp health. AIM and OBJECTIVES: Aim: To evaluate and compare the clinical and radiographic success of indirect pulp capping with three different materials (Calcium hydroxide, EndoSequence Root repair material and ACTIVA bioACTIVE at 3, 6, 9 and 12 month interval. Objectives: 1. To evaluate the clinical and radiographic success of indirect pulp capping agents (Calcium hydroxide, EndoSequence root repair material and ACTIVA BioACTIVE. 2. To assess the effectiveness of EndoSequence root repair material and ACTIVA BioACTIVE when compared with Calcium hydroxide (Dycal). MATERIAL AND METHODS: Study Setting: The study will be conducted at the Post-Graduate Clinic, Department of Paediatric and Preventive Dentistry, King George’s Medical University, Lucknow, Uttar Pradesh. Study Design: This is a randomized controlled clinical trial conducted at the same department. Participants: Children aged 4-9 years will be screened. Inclusion criteria focus on cooperative patients with dental issues, while exclusion criteria involve medical complications and uncooperative behavior. Randomization and Blinding: Participants will be divided into three groups using random numbers. Allocation will be concealed. A single operator will perform the procedures, and an independent observer will handle follow-up, ensuring blinding. Procedure: Informed consent will be obtained from parents, carious lesions will be treated with one of three materials, and follow-up evaluations will occur at 3, 6, 9, and 12 months. Sample Size: A total of 81 participants (27 per group) was calculated to be sufficient for statistical analysis. Statistical Analysis: Data will be analyzed using SPSS version 21. Categorical outcome measures will be compared using chi-square tests, with significance set at p<0.05.
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