| CTRI Number |
CTRI/2025/09/095189 [Registered on: 22/09/2025] Trial Registered Prospectively |
| Last Modified On: |
21/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Three Dental Materials for Protecting the Pulp in Deep Tooth Decay: An In Vivo Study |
|
Scientific Title of Study
|
Comparative evaluation of effectiveness of Nanohydroxyapatite-Conventional Glass Ionomer Cement and TheraCal LC as indirect pulp capping agent in deep dental caries-An in vivo study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr.(Prof) PAROMITA MAZUMDAR |
| Designation |
Professor and Head Of the Department of conservative dentistry and endodontics |
| Affiliation |
Guru Nanak Institute Of Dental Sciences and Research |
| Address |
HIG-IIA 7/14 1050/2, SURVEY PARK, CALCUTTA GREEN PHASE-II, HOUSING COMPLEX, KOLKATA-700075
South Twentyfour Parganas
WEST BENGAL
700075
India |
| Phone |
9831029606 |
| Fax |
|
| Email |
headcons.gnidsr@jisgroup.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.(Prof) Paromita Mazumdar |
| Designation |
Professor and Head Of the Department of conservative dentistry and endodontics |
| Affiliation |
Guru Nanak Institute Of Dental Sciences and Research |
| Address |
HIG-IIA 7/14 1050/2, SURVEY PARK, CALCUTTA GREEN PHASE-II, HOUSING COMPLEX, KOLKATA-700075
South Twentyfour Parganas
WEST BENGAL
7000075
India |
| Phone |
9831029606 |
| Fax |
|
| Email |
headcons.gnidsr@jisgroup.org |
|
Details of Contact Person
Public Query
|
| Name |
Tiyasha Roy |
| Designation |
Post graduate trainee of conservative dentistry and endodontics |
| Affiliation |
Guru Nanak Institute Of Dental Sciences and Research |
| Address |
House no. 511, A.C. Nath street, Chartala, P.O. Nawabganj, Ichapore
North Twentyfour Parganas
WEST BENGAL
743144
India |
| Phone |
9831029606 |
| Fax |
|
| Email |
tiyasharoy2018@gmail.com |
|
|
Source of Monetary or Material Support
|
| Guru Nanak Institute Of Dental Sciences and Research.
57/F, Nilgunj Road, Panihati, Kolkata- 700 114 |
|
|
Primary Sponsor
|
| Name |
Tiyasha Roy |
| Address |
House no 511, Chartala, Ichapore, P.O. Nawabganj, pin-73144 |
| Type of Sponsor |
Other [Post graduate trainee] |
|
|
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 |
| Tiyasha Roy |
Guru Nanak Institute of Dental Sciences and Research |
157/F, Nilgunj Rd, Sahid Colony, Panihati, Kolkata, Khardaha, West Bengal 700114
North Twentyfour Parganas
WEST BENGAL |
9674068829
tiyasharoy2018@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Guru Nanak Institute Of Dental Sciences and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Deep dental caries |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nanohydroxyapatite-Conventional Glass Ionomer Cement |
Nanohydroxyapatite-Conventional Glass Ionomer Cement improves the property of glass ionomer cement and reduces the side effects |
| Comparator Agent |
Theracal LC |
Theracal LC promote healing , maintain pulp vitality, helps to formation of dentinal bridge. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Posterior teeth with deep carious lesion
Teeth with vital pulp
Teeth with fully formed apices
Age group -18-40 years
|
|
| ExclusionCriteria |
| Details |
Oral habits like bruxism, parafunctional habits and abnormal occlusion.
Teeth with periapical pathology
Teeth with swelling or fistula, periapical or bifurcation radiolucency
Teeth with external and internal resorption
The teeth with spontaneous pain.
Any previous restoration, Fractured restoration and replacement restoration
Presence of fracture line in a tooth
|
|
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Method of Generating Random Sequence
|
|
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Method of Concealment
|
|
|
Blinding/Masking
|
|
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Primary Outcome
|
| Outcome |
TimePoints |
Absence of Pain and sensitivity
Positive for vitality test
No tenderness to percussion
No periapical changes
No secondary caries progression
No swelling
|
1 month, 3 month and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="38"
Sample Size from India="38"
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)
|
02/11/2025 |
| 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="6"
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
|
In this in vivo study thirty eight number of patient diagnosed with deep caries will be selected. The age range of the patient should be 18-40 years, the teeth with fully formed apices, teeth with vital pulp will be selected .Then the clinical and radiographical evaluation will be done. Only cases of deep carious lesion evaluated radiographically approximating the pulp and without involvement of any pulp space will be selected. Following rubber dam isolation excavation of carious lesion and removal of infected dentin will be done by smart bur. If the remaining dentinal thickness is 0.5 mm-1 mm then the case will be selected for indirect pulp capping. Then the cavity will be disinfected by 2% Chlorohexidine. Indirect pulp capping will be done on these patients dividing into two group by simple randomization technique. In Group A -Nanohydroxyapatite-conventional GIC and Group B-Thera Cal LC will be given over the remaining dentin followed by temporary restoration by RMGIC. After 1 month temporary restoration will be removed and permanent restoration of composite will be given .Clinical and radiographical evaluation done in 1 month, 3 month and 6 month follow up |