| CTRI Number |
CTRI/2024/05/067644 [Registered on: 20/05/2024] Trial Registered Prospectively |
| Last Modified On: |
18/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Therapeutic Intervention in participants having deep carious lesion by Indirect Pulp Capping Treatment with three different biomaterials and evaluate the clinical and radiographic outcomes. |
|
Scientific Title of Study
|
Odontogenic Responses of human dental pulp to indirect pulp treatment by different biomaterials - A Prospective Clinical 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 Krunali Jayswal |
| Designation |
Post Graduate Student |
| Affiliation |
Narsinhbhai Patel Dental College and Hospital |
| Address |
Room No.5, Department of Conservative Dentistry and Endodontics , Narsinhbhai Patel Dental College and Hospital, Sankalchand Patel University, Visnagar,Mehsana
Mahesana
GUJARAT
384315
India |
| Phone |
8511112209 |
| Fax |
|
| Email |
dr.krunali001@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kailash Attur |
| Designation |
Professor and Head |
| Affiliation |
Narsinhbhai Patel Dental College and Hospital |
| Address |
Room No.5, Department of Conservative Dentistry and Endodontics , Narsinhbhai Patel Dental College and Hospital, Sankalchand Patel University, Visnagar,Mehsana
Mahesana
GUJARAT
384315
India |
| Phone |
9727752499 |
| Fax |
|
| Email |
atturkailash@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Krunali Jayswal |
| Designation |
Post Graduate Student |
| Affiliation |
Narsinhbhai Patel Dental College and Hospital |
| Address |
Room No.5, Department of Conservative Dentistry and Endodontics , Narsinhbhai Patel Dental College and Hospital, Sankalchand Patel University, Visnagar,Mehsana
Mahesana
GUJARAT
384315
India |
| Phone |
08511112209 |
| Fax |
|
| Email |
dr.krunali001@gmail.com |
|
|
Source of Monetary or Material Support
|
| Narsinhbhai Patel Dental College and Hospital, Sankalchand Patel University, Visnagar, Mehsana 384315 |
|
|
Primary Sponsor
|
| Name |
Narsinhbhai Patel Dental College and Hospital |
| Address |
Narsinhbhai Patel Dental College and Hospital, Sankalchand Patel University, Near Kamana Circle, Visnagar, Mehsana 384315 |
| Type of Sponsor |
Research institution 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 |
| DrKrunali Jayswal |
Narsinhbhai Patel Dental College and Hospital |
Room No.5, Department of Conservative Dentistry and Endodontics , Narsinhbhai Patel Dental College and Hospital, Sankalchand Patel University, Visnagar,Mehsana
Mahesana
GUJARAT |
08511112209
dr.krunali001@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Narsinhbhai Patel Dental College Visnagar |
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 |
| Intervention |
Indirect Pulp Capping Treatment |
Evaluate efficacy of eggshell derived hydroxyapatite, Light cure Resin Based material (Theracal LC) and MTA based material (Biodentine) clinically by checking postoperative pain, tenderness, neural sensibility and radiographically by pdl space widening, presence of calcific barrier and periapical radiolucency at 1,3,6 and 9 months interval. |
| Comparator Agent |
Indirect Pulp Capping Treatment |
Theracal LC and Biodentine |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1)Tooth should be mature permanaent tooth showing closed apex in peroapical radiograph
2)Permanent posterior teeth with deep dentinal caries
3)Class I caries
4)teeth diagnosed with reversible pulpitis
5)Radiographically depth of caries should be more than 70 percentage or more than two thirds of dentin thickness |
|
| ExclusionCriteria |
| Details |
1)Deciduous teeth
2)Allergy to egg protein
3)No pulpal exposure post completion of caries removal
4)Teeth showing signs if irreversible pulpitis
5)Extensive pulpal carious lesion
6)Acute pulpal inflammation
7)Pulp Necrosis
8)Pathological Mobility
9)Tooth showing internal external resorption
10)Periapical Abscess
11)Fistula
12)Patient on antibiotic or analgesic course within a week prior to the start of treatment |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Determine which pulp capping agent has higher efficacy in pulp capping treatment |
1, 3,6 and 9 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare and evaluate efficacy of EggShell derived Hydroxyapatite, Biodentine and Theracal LC as IPC agent clinically by
checking postoperative pain, tenderness, neural sensibility, and radiographically by
checking PDL space widening, presence of calcific barrier and periapical
radiolucency |
1, 3,6 and 9 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
09/05/2025 |
| 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="0"
Months="9"
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
|
30 participants will be selected according to inclusion criteria for indirect pulp capping and divided in 3 groups respectively to evaluate efficacy of EggShell derived Hydroxyapatite, Theracal LC and Biodentine as Indirect Pulp Capping agent clinically by checking postoperative pain, tenderness, neural sensibility, and radiographically by checking PDL space widening, presence of calcific barrier and periapical radiolucency at 1,3,6 and 9 months interval. |