| CTRI Number |
CTRI/2024/01/061916 [Registered on: 29/01/2024] Trial Registered Prospectively |
| Last Modified On: |
29/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the effects of two light cured indirect pulp capping agents |
|
Scientific Title of Study
|
A randomized controlled clinical trial to compare two light cured indirect pulp capping agents : 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 |
Sarikarani Barnwal |
| Designation |
PG student |
| Affiliation |
College of Dental sciences and research center |
| Address |
Department of conservative dentistry and endodontics, silver alaknanda dental college road, Nr. Navneet printing press, Opposite pleasure club, Bopal, Manipur
Ahmadabad
GUJARAT
380058
India |
| Phone |
07984494900 |
| Fax |
|
| Email |
srbwal1996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shilpa Shah |
| Designation |
Professor |
| Affiliation |
College of Dental sciences and research center |
| Address |
Department of conservative dentistry and endodontics, Silver alaknanda dental college road, Nr. Navneet printing press, Opp. Pleasure Club, Bopal, Manipur
Ahmadabad
GUJARAT
380058
India |
| Phone |
9376121229 |
| Fax |
|
| Email |
drshah16@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shilpa Shah |
| Designation |
Professor |
| Affiliation |
College of Dental sciences and research center |
| Address |
Department of conservative dentistry and endodontics, Silver alaknanda dental college road, Nr. Navneet printing press, Opp. Pleasure Club, Bopal, Manipur
Ahmadabad
GUJARAT
380058
India |
| Phone |
9376121229 |
| Fax |
|
| Email |
drshah16@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of conservative dentistry and endodontics, Silver alaknanda, Dental college road, Nr. Navneet Printing Press, Opposite Pleasure Club, Bopal, Manipur, Ahmedabad, Gujarat, India -380058 |
|
|
Primary Sponsor
|
| Name |
College of dental sciences and research center |
| Address |
Department of conservative dentistry and Endodontics, Silver Alaknanda Dental College road ,Nr. Navneet Printing Press Opp.Pleasure Club, Bopal, Manipur, Ahmedabad |
| Type of Sponsor |
Other [Private dental college and hospital] |
|
|
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 Shilpa Shah |
College of Dental Sciences and Research Center |
Department of conservative dentistry and endodontics,Silver Alaknanda Dental college road, Nr.Navneet Printing Press, Opp. Pleasure Club, Bopal, Manipur, Ahmedabad, Gujarat
Ahmadabad
GUJARAT |
9376121229
drshah16@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee College Of Dental Sciences And Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Biner LC |
Dose- 1g
Frequency of adminstration- Once
Route of administration- Via syringe over lesion
Duration of therapy - around 10 to 15 minutes |
| Intervention |
Hydrocal LC |
Dose- 1g
Frequeny of drug administration - once
Route of Administration- via syringe over lesion
Duration of therapy - around 10 to 15 minutes
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Posterior Teeth having occlusal or proximal deep carious lesion, Healthy periodontium |
|
| ExclusionCriteria |
| Details |
Teeth with pulp exposure, Sinus opening, Mobility, Cracked tooth |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the pain and tooth sensitivity after treatment long-term outcome of Biner LC over Hydrocal LC as an indirect pulp capping material. |
The outcome would be assessed at baseline, 1 week,1 month, 3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe whether any periapical lesion is developing or not via radiographs during follow up periods |
At 1 week, 3 months & 6 months period during follow up after treatment is provided |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
22/02/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
22/02/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
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
|
A Randomized Controlled Clinical Trial to compare two light cured indirect pulp capping agents: an in-vivo study
Aim: This study aims to evaluate the prognostic value of factors with regard to the treatment outcome of indirect pulp capping using Biner LC (METABIOMED Co. LTD) and Hydrocal LC (Medicept Co. Ltd) in permanent posterior teeth having Remaining Dentin Thickness (RDT) of less than or equal to 1.5 mm. Material and method:  40 teeth with deep carious lesions and RDT of less than or equal to 1.5 mm are selected for indirect pulp capping. Patients are randomly divided into Biner LC and Hydrocal LC groups (n=20 in each group). The patients would be followed up at interval of 1 week, 1 month, 3 months and 6 months with a routine examination on all recall visits. Periapical radiographs would be taken, lack of patient complaints, positive reactions to electric pulp testing, no sensitivity to percussion, and no widening of the periapical ligament indicated success.
Statistical Analysis: The results would be analysed via One way ANOVA test, Chi square test and Paired t- test . Data would be collected and statistically analyzed. Various prognostic factors would be analyzed in this study for the significance of indirect pulp capping agents. |