| CTRI Number |
CTRI/2019/04/018686 [Registered on: 22/04/2019] Trial Registered Retrospectively |
| Last Modified On: |
29/12/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical evaluation of biodentine and calcium hydroxide in managing deep carious lesion with the use of cone beam computed tomography |
|
Scientific Title of Study
|
CLINICAL EVALUATION OF BIO-DENTINE AND CALCIUM HYDROXIDE IN DEEP CARIES MANAGEMENT WITH USING CONE BEAM COMPUTED TOMOGRAPHY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Divyameena |
| Designation |
MDS 1st year |
| Affiliation |
CSI COLLEGE OF DENTAL SCIENCES AND RESEARCH |
| Address |
DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS, ROOM NO : 6 , 129 CMH COMPOUND
EAST VELI STREET
MADURAI
Madurai
TAMIL NADU
625001
India |
| Phone |
9952463468 |
| Fax |
|
| Email |
divyameena@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Divyameena |
| Designation |
MDS 1st year |
| Affiliation |
CSI COLLEGE OF DENTAL SCIENCES AND RESEARCH |
| Address |
DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS, ROOM NO : 6 ,129 CMH COMPOUND
EAST VELI STREET
MADURAI
Madurai
TAMIL NADU
625001
India |
| Phone |
9952463468 |
| Fax |
|
| Email |
divyameena@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR ANAND SHERWOOD |
| Designation |
MDS.,Ph.D., |
| Affiliation |
CSI COLLEGE OF DENTAL SCIENCES AND RESEARCH |
| Address |
DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS, ROOM NO : 6 ,129 CMH COMPOUND
EAST VELI STREET
MADURAI
Madurai
TAMIL NADU
625001
India |
| Phone |
9443805150 |
| Fax |
|
| Email |
anand.sherwood@gmail.com |
|
|
Source of Monetary or Material Support
|
| CSI College of Dental Sciences and Research |
|
|
Primary Sponsor
|
| Name |
CSI college of Dental Sciences and Reaseach |
| Address |
129 CMH COMPOUND EAST VELI STREET MADURAI |
| 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 |
| Divyameena |
CSI college of Dental Sciences and Research |
129,EAST VELI STREET, CMH COMPOUND
Madurai
TAMIL NADU |
9952463468
divyameena@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional csi college of dental sciences and research |
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 |
biodentine cement |
tricalcium silicate cement |
| Comparator Agent |
dycal |
calcium hydroxide cement |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
deep carious tooth with least remaining dentin thickness less than 1mm , provided pre operative symptoms are concern with no pulpitis or reversible pulpitis |
|
| ExclusionCriteria |
| Details |
tooth with irreversible pulpitis and severe pain symptoms |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| VITALITY OF PULP |
60 DAYS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| VITALITY OF PULP |
1 YEAR |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
Final Enrollment numbers achieved (Total)= "59"
Final Enrollment numbers achieved (India)="59" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/01/2018 |
| Date of Study Completion (India) |
30/09/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
this study evaluates the effectiveness of a newer tricalcium silicate based cement namely, biodentine compared with calcium hydroxide in the management of deep carious lesions by indirect pulp capping procedure. molar teeth with deep caries in inner 4th of dentin, evaluated with intraoral periapical radiograph and cbct are selected. treated with either biodentine or calcium hydroxide with composite restorations. follow up is for 2 years. the influence of the material in the success of deep caries and diagnostic effectiveness of cbct is to be evaluated. the purpose of this study is to successfully manage deep carious lesions by indirect pulp capping rather going for an invasive option like root canal procedure.
|