| CTRI Number |
CTRI/2024/10/074592 [Registered on: 01/10/2024] Trial Registered Prospectively |
| Last Modified On: |
01/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A clinical trail to study the effects of calcium hydroxide and biodentin as pulp capping agents when used alone or in combination with laser |
|
Scientific Title of Study
|
Efficacy of calcium hydroxide and biodentin with or without Diode and Er:YAG Laser assisted direct pulp capping treatment - A randomised controlled 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 |
Dr K Rashmi |
| Designation |
Assistant Professor |
| Affiliation |
|
| Address |
Government Dental College and Research Institute
room no 4, department of conservative dentistry and endodontics
Fort, Victoria hospital campus Bangalore
Bangalore
KARNATAKA
560002
India |
| Phone |
9741113002 |
| Fax |
|
| Email |
rashmiendo@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K Rashmi |
| Designation |
Assistant Professor |
| Affiliation |
|
| Address |
Government Dental College and Research Institute, room no 4, department of conservative dentistry and endodontics
Fort, Victoria hospital campus Bangalore
Bangalore
KARNATAKA
560002
India |
| Phone |
9741113002 |
| Fax |
|
| Email |
rashmiendo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr K Rashmi |
| Designation |
Assistant Professor |
| Affiliation |
|
| Address |
Government Dental College and Research Institute, room no 4, department of conservative dentistry and endodontics
Fort, Victoria hospital campus Bangalore
Bangalore
KARNATAKA
560002
India |
| Phone |
9741113002 |
| Fax |
|
| Email |
rashmiendo@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Dental College and Research Institute, room no 4, department of conservative dentistry and endodontics
Fort, Victoria hospital, Bangalore -560002, Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Dr K Rashmi |
| Address |
Government Dental College and Research Institute, room no 4, department of conservative dentistry and endodontics
Fort, Victoria hospital, Bangalore |
| Type of Sponsor |
Other [Dr K Rashmi] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| self |
Government Dental College and Research Institute
Fort, Victoria hospital, |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr K Rashmi |
Government Dental College and Research Institute |
room no 4, department of conservative dentistry and endodontics, fort, victoria hospital campus, bangalore
Bangalore
KARNATAKA |
9741113002
rashmiendo@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee,Government Dental College and Research Institute,Bangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
calcium hydroxide and diode laser
calcium hydroxide and Er:YAG laser
biodentin and diode laser biodentin and Er:YAG laser |
diode laser and Er:YAG laser used for photobiomodulation for 60seconds
calcium hydroxide and biodentin applied to exposed pulp left as direct pulp capping agent
followed up for one year |
| Comparator Agent |
calcium hydroxide, biodentin |
calcium hydroxide and Biodentin are used as direct pulp capping agent and followed up for one year |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
tooth responding positively to cold test with reversible pulpitis
permanent teeth with closed apices and carious exposure not larger than 2 mm in diameter
tooth with pulpal bleeding controlled within 10 minutes after pulp exposure
teeth that can be restored with composite, amalgam |
|
| ExclusionCriteria |
| Details |
tooth with associated pain, swelling, pus discharge, fistula or abnormal mobility
teeth with periapical changes, internal or pathologic external root resorption, calcification or pulp canal obliteration |
|
|
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 |
| patient will be evaluated for vitality test, intact coronal restoration, presence or absence of pain/swelling |
patient will be evaluated for vitality test, intact coronal restoration, presence or absence of pain/swelling at baseline, one month, three months, six months and one year follow-up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| radiographic evaluation for presence or absence of periapical changes will be done |
radiographic evaluation for presence or absence of periapical changes at baseline, one month, three months, six months & one year follow up will be done |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
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="0"
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
|
this study is a randomised control trial which is used to compare the efficacy of calcium hydroxide and biodentin direct pulp capping agents used with or without diode laser and Er:YAG laser application. the primary outcome evaluates the vitality test, intact coronal restoration, presence or absence of pain/swelling at one, three, six months and one year recall. secondary outcome evaluates radiograph for presence or absence of periapical radiolucency |