| CTRI Number |
CTRI/2020/01/023019 [Registered on: 28/01/2020] Trial Registered Prospectively |
| Last Modified On: |
22/01/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
TOOTH COLORED RESTORATION FOR DISCOLORED FRACTURED ROOT CANAL TREATED TOOTH |
|
Scientific Title of Study
|
CLINICAL EVALUATION OF DIRECT COMPOSITE VENEERING ON DISCOLORED ROOT CANAL TREATED MAXILLARY INCISOR TOOTH-AN IN VIVO STUDY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
RAHUL B |
| Designation |
POSTGRADUATE STUDENT |
| Affiliation |
CSI COLLEGE OF DENTAL SCIENCES AND RESEARCH |
| Address |
129,CMH COMPOUND, OLD KUYAVAR PALAYAM MAIN ROAD, EAST VELI STREET, MADURAI
129 CMH COMPOUND, OLD KUYAVAR PALAYAM MAIN ROAD, EAST VELI STREET, MADURAI
Madurai
TAMIL NADU
625001
India |
| Phone |
7598326175 |
| Fax |
|
| Email |
raghulram22@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr I ANAND SHERWOOD |
| Designation |
PROFESSOR AND HEAD OF THE DEPARTMENT |
| Affiliation |
CSI COLLEGE OF DENTAL SCIENCES AND RESEARCH |
| Address |
129 CMH COMPOUND, EAST VELI STREET, MADURAI - 625001
129 CMH COMPOUND, EAST VELI STREET, MADURAI - 625001
Madurai
TAMIL NADU
625001
India |
| Phone |
9791443950 |
| Fax |
|
| Email |
anand.sherwood@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
B RAHUL |
| Designation |
POSTGRADUATE STUDENT |
| Affiliation |
CSI COLLEGE OF DENTAL SCIENCES AND RESEARCH |
| Address |
129 CMH COMPOUND
EAST VELI STREET
MADURAI
129 CMH COMPOUND
EAST VELI STREET
MADURAI
Madurai
TAMIL NADU
625001
India |
| Phone |
7598326175 |
| Fax |
|
| Email |
raghulram22@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 |
129 CHRISTIAN MISSION HOSPITAL COMPOUND, EAST VELI STREET, MADURAI - 625001 |
| 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 |
| RAHUL B |
CSI COLLEGE OF DENTAL SCIENCES AND RESEARCH |
ROOM NO 6
DEPARTMENT OF OPERATIVE AND CONSERVATIVE DENTISTRY
Madurai
TAMIL NADU |
7598326175
raghulram22@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITEE & 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 |
DIRECT COMPOSITE VENEERING |
TOOTH PREPARATION DONE ON DISCOLORED MAXILLARY INCISOR TOOTH FOLLOWED BY OPAQUER PLACEMENT AND VENEERING DONE ON THE TOOTH SURFACE AND EVALUATED FOR A PERIOD OF 18 MONTHS |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
DISCOLORED ROOT CANAL TREATED MAXILLARY INCISOR TOOTH |
|
| ExclusionCriteria |
| Details |
PATIENTS WITH PARAFUNCTIONAL HABITS
PATIENTS WITH POOR ORAL HYGIENE
PERIODONTALLY COMPROMISED PATIENTS
PATIENTS NOT WILLING FOR RECALL |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| RETENTIVE QUALITY OF THE RESTORATION |
18 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| ESTHETIC OUTCOME OF THE RESTORATION |
18 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
N/A |
|
Date of First Enrollment (India)
|
29/01/2020 |
| 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) |
Closed to Recruitment of Participants |
|
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 clinical and functional efficacy of direct composite veneers in discolored root canal treated maxillary incisors over a 18 month follow up using digital SLR photographs. The purpose of this study is to successfully manage discolored endodontically treated tooth by direct composite veneering rather going for an invasive option like crowns. |