| CTRI Number |
CTRI/2023/11/060180 [Registered on: 23/11/2023] Trial Registered Prospectively |
| Last Modified On: |
26/11/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of half metal cap(metal onlay) or full metal cap(metal crown) better on root canal treated back teeth |
|
Scientific Title of Study
|
Comparing metal onlay and metal crown on root canal treated first and second molars with single proximal defect - An 18 month clinical study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Evelyn Benisha R |
| Designation |
Post graduate student |
| Affiliation |
CSI college of dental sciences and research |
| Address |
CSI college of dental sciences and research , Department of conservative dentistry and endodontics, Room number 6 , 129 CMH Compound , old kuyavarpalayam road , East veli street , Madurai
Madurai
TAMIL NADU
625001
India |
| Phone |
9626225247 |
| Fax |
|
| Email |
evelynbenisha100@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr I Anand Sherwood |
| Designation |
HOD and professor of Operative Dentistry and Endodontics |
| Affiliation |
CSI college of dental sciences and research |
| Address |
CSI college of dental sciences and research , Department of conservative dentistry and endodontics, Room number 6, 129 CMH Compound , old kuyavarpalayam road , East veli street , Madurai
Madurai
TAMIL NADU
625001
India |
| Phone |
9443805150 |
| Fax |
|
| Email |
anand.sherwood@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr I Anand Sherwood |
| Designation |
HOD and professor of Operative Dentistry and Endodontics |
| Affiliation |
CSI college of dental sciences and research |
| Address |
CSI college of dental sciences and research , Department of conservative dentistry and endodontics, Room number 6, 129 CMH Compound , old kuyavarpalayam road , 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 Research |
| Address |
CSI College of Dental Sciences and Research ,Room number 6 , 129 CMH Compound , old kuyavarpalayam road, 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 |
| Dr Evelyn Benisha R |
CSI college of dental sciences and research |
Department of conservative dentistry and endodontics ,Room number 6 , 129 CMH Compound , old kuyavarpalayam road, East veli street , Madurai
Madurai
TAMIL NADU |
9626225247
evelynbenisha100@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE AND INSTITUTIONAL REVIEW BOARD |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K085||Unsatisfactory restoration of tooth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Metal crowns on root canal treated first and second molars with single proximal defect |
Metal crowns on root canal treated first and second molars with single proximal defect with follow up of 18 months |
| Intervention |
Metal onlays on root canal treated first and second molars with single proximal defect |
Metal onlays on root canal treated first and second molars with single proximal defect with follow up of 18 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
With satisfactory endodontic treatment and no radiographic or clinical evidence of root canal treatment failure
Root canal treated first and second molars with single proximal defect
Opposing teeth should be present
|
|
| ExclusionCriteria |
| Details |
Patient not willing for recall visits
Patients with parafunctional habits
Periodontally compromised patients
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| compare the survival rate of metal onlays over metal crown in root canal treated first and second molars with single proximal defect |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Compare the success rate of metal onlays over metal crown in root canal treated first and second molars with single proximal defect
|
18 months |
|
|
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
01/12/2023 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Comparing the survival rate and success rate of metal onlays over metal crown on root canal treated first and second molars with single proximal defect with duration of follow up of 18 months |