| CTRI Number |
CTRI/2020/02/023417 [Registered on: 18/02/2020] Trial Registered Prospectively |
| Last Modified On: |
14/07/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Direct composite restoration for fractured root canal treated upper front teeth. |
|
Scientific Title of Study
|
The clinical evaluation of teeth with direct composite restorations reflecting different restorative designs in fractured endodontically treated maxillary incisors teeth- An invivo study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pradeepa M R |
| Designation |
Post graduate student |
| Affiliation |
CSI college of dental sciences and research |
| Address |
Room no 6
Department of operative dentistry and endodontics
Madurai
TAMIL NADU
625001
India |
| Phone |
9789782066 |
| Fax |
|
| Email |
drpradeepa@icloud.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 |
Room no 6
Department of operative dentistry and endodontics
Madurai
TAMIL NADU
625001
India |
| Phone |
9443805150 |
| Fax |
|
| Email |
anand.sherwood@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pradeepa M R |
| Designation |
Post graduate student |
| Affiliation |
CSI college of dental sciences and research |
| Address |
Room no 6
Department of operative dentistry and endodontics
Madurai
TAMIL NADU
625001
India |
| Phone |
9789782066 |
| Fax |
|
| Email |
drpradeepa@icloud.com |
|
|
Source of Monetary or Material Support
|
| CSI college of dental sciences and research
129,CMH compound, East Veli Street, Madurai, Tamil Nadu : 625001 |
|
|
Primary Sponsor
|
| Name |
Pradeepa M R |
| Address |
CSI College of dental sciences and research
129, CMH Compound ,East Veli Street, Madurai-625001 |
| Type of Sponsor |
Other [] |
|
|
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 |
| Pradeepa M R |
CSI college of dental sciences and research |
Room no:6
Department of Conservative dentistry and Endodontics
No.129,East Veli Street, Madurai-625001
Madurai
TAMIL NADU |
9789782066
drpradeepa@icloud.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee & Institutional Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z768||Persons encountering health services in other specified circumstances, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Coronoradicular composite restoration |
Direct composite restoration will be done from the radicular portion (2-4mm from the DEJ) |
| Comparator Agent |
Fibre post followed by composite core build up |
Radicular portion will be prepared to receive a fibre post. The post will be luted using resin cement. Core build up will be done using composites. |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
50-75% of the cinical crown loss only due to fracture. |
|
| ExclusionCriteria |
| Details |
Incisors affected by dental caries.
Previously treated root canal teeth.
Periodontally compromised teeth.
Patients with bilateral missing teethh. |
|
|
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 Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Retentive quality of the coronoradicular and fibre post and core restorations. |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Aesthetic quality of the restorations. |
18 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "56"
Final Enrollment numbers achieved (India)="56" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
22/02/2020 |
| Date of Study Completion (India) |
15/03/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
15/03/2022 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
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 clinically evaluates and compares the functional efficiency and aesthetics of coronoradicular direct composite restoration with fibre post composite restoration over 18 months follow up. |