| CTRI Number |
CTRI/2020/02/023141 [Registered on: 05/02/2020] Trial Registered Prospectively |
| Last Modified On: |
07/02/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
SURVIVAL OF FRAGMENT REATTACHMENT IN COMPLICATED CROWN FRACTURE OF MAXILLARY INCISOR TOOTH |
|
Scientific Title of Study
|
CLINICAL EVALUATION OF COMPLICATED CROWN FRACTURE OF MAXILLARY INCISORS TREATED WITH FRAGMENT REATTACHMENT :A 4 YEAR REPORT |
| 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, EAST VELI STREET, MADURAI
129,CMH COMPOUND, EAST VELI STREET, MADURAI
Madurai
TAMIL NADU
625001
India |
| Phone |
7598326175 |
| Fax |
|
| Email |
raghulram22@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
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
ROOM NO 6,129,CMH COMPOUND, EAST VELI STREET, MADURAI
Madurai
TAMIL NADU
625001
India |
| Phone |
9443805150 |
| Fax |
|
| Email |
anand.sherwood@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
RAHUL B |
| 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 129,CMH COMPOUND, EAST VELI STREET, MADURAI - 625001 |
|
|
Primary Sponsor
|
| Name |
Csi college of dental sciences and research |
| 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 |
| RAHUL B |
Csi college of dental sciences and research |
Room no 6
DEPARTMENT OF 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: Z139||Encounter for screening, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Complicated Crown Fracture Of Maxillary Incisor tooth |
Tooth Fragment reattachment |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
MAXILLARY INCISOR TOOTH WITH FRACTURED TOOTH FRAGMENT |
|
| ExclusionCriteria |
| Details |
PATIENTS WITH PARAFUNCTIONAL HABITS
PATIENTS WITH POOR ORAL HYGIENE
PATIENTS NOT WILLING FOR RECALL
PERIODONTALLY COMPROMISED PATIENTS |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| LONGEVITY OF THE REATTACHED FRAGMENT |
48 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| ESTHETIC QUALITY OF THE FRACTURED FRAGMENT |
48 months |
|
|
Target Sample Size
|
Total Sample Size="5"
Sample Size from India="5"
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)
|
07/02/2020 |
| 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="4"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Nil |
|
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 THE FRAGMENT REATTACHMENT TREATMENT PROGNOSIS OF THE FRACTURED MAXILLARY INCISOR TOOTH FOR A PERIOD OF 4 YEARS. THE PURPOSE OF THIS STUDY IS TO SUCCESSFULLY MANAGE A FRACTURED MAXILLARY INCISOR TOOTH BY FRAGMENT REATTACHMENT RATHER THAN FULL CROWN COVERAGE |