| CTRI Number |
CTRI/2025/06/089515 [Registered on: 25/06/2025] Trial Registered Prospectively |
| Last Modified On: |
24/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of various indirect pulp capping agents in primary molars. |
|
Scientific Title of Study
|
Comparative evaluation of calcium hydroxide, resin-modified glass-ionomer cement and enhanced resin-modified glass-ionomer as indirect pulp capping agent in primary molars: a randomised 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 Yogesh Kale |
| Designation |
Professor and Head of the Department |
| Affiliation |
MIDSR Dental College, Latur, Maharashtra |
| Address |
Room no. 6 Ground floor Department of Pediatric and Preventive
Dentistry, MIDSR Dental College, Latur, Maharashtra
Latur
MAHARASHTRA
413512
India
Latur
MAHARASHTRA
413512
India |
| Phone |
980588705 |
| Fax |
|
| Email |
dryogesh77@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mansi Bhakkad |
| Designation |
Post graduate student |
| Affiliation |
MIDSR Dental College, Latur, Maharashtra |
| Address |
Room no. 6 Ground floor Department of Pediatric and Preventive
Dentistry, MIDSR Dental College, Latur, Maharashtra
Latur
MAHARASHTRA
413512
India
Latur
MAHARASHTRA
413512
India |
| Phone |
8983817566 |
| Fax |
|
| Email |
mansi.bhakkad1234@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mansi Bhakkad |
| Designation |
Post graduate student |
| Affiliation |
MIDSR Dental College, Latur, Maharashtra |
| Address |
Room no. 6 Ground floor Department of Pediatric and Preventive
Dentistry, MIDSR Dental College, Latur, Maharashtra
Latur
MAHARASHTRA
413512
India
Latur
MAHARASHTRA
413512
India |
| Phone |
8983817566 |
| Fax |
|
| Email |
mansi.bhakkad1234@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room no. 6 Ground floor Department of Pediatric And Preventive Dentistry, MIDSR DentalCollege, Latur, Maharashtra |
|
|
Primary Sponsor
|
| Name |
Dr Mansi bhakkad |
| Address |
Room no. 6 Ground floor Department of Pediatric And Preventive
Dentistry, MIDSR Dental College, Latur, Maharashtra |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Yogesh Kale |
Room no. 6 Ground floor Department of Pediatric And Preventive
Dentistry, MIDSR Dental College, Latur, Maharashtra |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Yogesh Kale |
MIDSR Dental College, Latur, Maharashtra |
Room no. 6,
Department of Pediatric
And Preventive
Dentistry, MIDSR
Dental College Latur,
Maharashtra
Latur
MAHARASHTRA
Latur
MAHARASHTRA |
9890588705
dryogesh77@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, MIDSR Dental College, Latur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: K025||Dental caries on pit and fissure surface, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Calcium hydroxide |
Clinical and radiographic effect of calcium hydroixde as indirect pulp capping agent
|
| Intervention |
Enhanced resin-modified glass-ionomer cement |
Clinical and radiographic effect of enhanced resin modified glass ionomer cement as indirect pulp capping agent |
| Intervention |
Resin-modified glass-ionomer cement |
Clinical and radiographic effect of resin modified glass ionomer cement as indirect pulp capping agent |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
1. Children in age group of 4-8 years
2. Children with carios primary molars ICADS score 4-6.
3. No histroy of spontaneous pain.
4. No tenderness observed on palpation and percussion 5. Absence of radiolucencies at the interradicular and/or periapical regions, as determined by periapical radiographs.
6. No evidence of internal or external resorption. |
|
| ExclusionCriteria |
| Details |
1. History of sharp, penetrating pulpal pain, indicating acute pulpal inflammation and necrosis.
2. Prolonged spontaneous pain at night.
3. Pathological mobility
4. Negative response to vitality test
5. Presence of abscess/fistula
6.Deep caries involving more than two-thirds of dentin thickness
7.No physiological root resorption
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
The effect of calcium hydroxide, resin-modified glass-ionomer cement
and enhanced resin-modified glass-ionomer when used as indirect pulp capping
agent in primary molars |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Among three calcium hydroxide, resin-modified glass-ionomer cement and enhanced resin-modified glass-ionomer have better efficacy as an indirect
pulp capping agent in primary molars |
3 months |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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 |
|
Date of First Enrollment (India)
|
10/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
07/07/2025 |
| 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
|
Dental caries is one of the most frequently occurring diseases affecting human beings that becomes a challenge for dentists as the disease progresses.1 The major dilemma for a pediatric dentist is to decide on the best treatment approach for carious primary teeth based on clinical and radiographic symptoms as children often present unreliable pain descriptions.2 Premature loss of deciduous tooth can lead to malocclusion, disintegration of dental arches, loss of function, and loss of esthetics. Hence, maintaining its vitality until its natural period of exfoliation is imperative for maintaining the arch form and integrity. To retain the tooth in the dental arch, either of the two treatments can be done, i.e., vital pulp therapy (VPT) or root canal treatment (RCT).3 Pulp capping is a minimal invasive vital therapy that preserves the pulp vitality of teeth with deep caries lesions or accidental pulp exposure. The exposed dentin-pulp tissues are covered with a medication in contact with a pulp wound to promote dentin-pulp healing and/or obliteration of the exposed pulp by a neoformed dentin bridge.4 Indirect pulp treatment (IPT) of primary teeth has gained increased worldwide popularity in recent years and has shown to have a lower cost, higher long-term success, better exfoliation pattern, and better success treating reversible pulpitis than pulpotomy.5 Indirect pulp capping (IPC) is one of the main processes of vital pulp therapy. It is a method in which preservation of affected carious dentin nearest to the pulp is carried out to prevent the exposure of the pulp. Then this layer of dentin is covered with a material that helps in formation of reparative dentin and protection of pulp.6 TITLE & SYNOPSIS 2 Calcium hydroxide (CH) is taken as the gold standard among all the pulp capping agents that are used. Its use was first put forward by Zander. There is formation of "reparative dentin," which takes place by cellular differentiation and extracellular matrix secretion. Subsequently, there is mineralization. Following this cascade of mechanism, a lot of drawbacks are seen. For example, there is an appearance of "tunnel defects" by the slow disintegrating "newly formed dentin." This phenomenon can be observed with CH when a long follow-up is taken. CH was found to be successful clinically by 97.6% after 16 months of follow-up and by 13% after 10 years of follow-up.7 Amidst other materials, calcium hydroxide was popularized for several decades but due to its limitations got replaced by newer agents such as Resin-modified glass ionomer (RMGI).2 Materials like resin-modified glass ionomer cement (RMGIC) that have additional adhesive properties have been introduced. It has been found that RMGIC are effective as IPC agents in adverse conditions such as minimum thickness of remaining dentin in teeth severely damaged by large carious lesions. Such an effect of RMGIC can be attributed to their additional adhesive properties with dentin and their antimicrobial properties.6 New-generation materials with bioactive glass particles have been used in all areas of dentistry in recent years to increase the bioactivity and regeneration capacity of dental materials. The most characteristic feature of bioactive glasses for medical use is that their surface consists of a layer of bioactive hydroxycarbonate apatite (HCA) that provides bonding with tissues. Thanks to this HCA layer, bioactive glasses can be chemically bound to the surrounding hard and soft tissues. It is thought that bioactive glasses can also be used in pulp-capping treatments because they stimulate hard tissue formation, can create dentin bridges that provide continuity, and have biocompatibility and antibacterial properties ACTIVA BioACTIVE-Base/Liner material with bioactive glass has physical properties of composite materials, such as esthetics and durability. However, it has been introduced as a combination of glass ionomer 3 containing materials, such as calcium and phosphate, with fluoride ion-releasing and -recycling properties.8 The purpose of this study is to compare and evaluate the three different agents i.e calcium hydroxide, resin-modifed glass-ionomer cement and enhanced resin modified glass-ionomer. This current study is design to compare and evaluate the clinical and radiographic success of three indirect pulp capping agent they are calcium hydroxide, resin-modifed glass-ionomer cement and enhanced resin-modified glass-ionomer in primary molars. |