| CTRI Number |
CTRI/2019/12/022546 [Registered on: 30/12/2019] Trial Registered Prospectively |
| Last Modified On: |
26/12/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Color Match of Composite material and Tooth structure Using Electronic Device (Spectrophotometer) |
|
Scientific Title of Study
|
Analysis of Color Match of Composite resin and Tooth remnant Using Spectrophotometer- A Randomized Clinical Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mohamed jubair hashir M |
| Designation |
Post graduate student |
| Affiliation |
jubairhashir@gmail.com |
| Address |
third floor, department of conservative and endodontics,
Thai Moogambigai dental college and hospital, maduravoyal, chennai
Chennai
TAMIL NADU
600107
India |
| Phone |
|
| Fax |
|
| Email |
jubairhashir@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR AR Pradeep Kumar |
| Designation |
head of the department |
| Affiliation |
Thai moogambigai dental college and hospital |
| Address |
third floor, department of conservative and endodontics,
Thai Moogambigai dental college and hospital, maduravoyal, chennai
Chennai
TAMIL NADU
600107
India |
| Phone |
|
| Fax |
|
| Email |
arpradeependo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR AR Pradeep Kumar |
| Designation |
head of the department |
| Affiliation |
Thai moogambigai dental college and hospital |
| Address |
third floor, department of conservative and endodontics,
Thai Moogambigai dental college and hospital, maduravoyal, chennai
Chennai
TAMIL NADU
600107
India |
| Phone |
|
| Fax |
|
| Email |
arpradeependo@gmail.com |
|
|
Source of Monetary or Material Support
|
| third floor department of conservative and endodontics thai moogambigai dental college and hospital chennai 600107 |
|
|
Primary Sponsor
|
| Name |
M Mohamed Jubair hashir |
| Address |
third floor, department of conservative and endodontics, thai moogambigai dental college and hospital, chennai 600107 |
| Type of Sponsor |
Other [self] |
|
|
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 |
| mmohamed jubair hashir |
thai moogambigai dental college and hospital |
third floor, department of conservative and endodontics,
Thai Moogambigai dental college and hospital, maduravoyal, chennai
Chennai
TAMIL NADU |
8220362339
jubairhashir@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DR.MGR EDUCATIONAL AND RESEARCH INSTITUTE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
class 4 dental caries |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
filtek z250 |
colour match in class4 restoration |
| Comparator Agent |
ips empress composite |
colour match in class 4 restoartion |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Patient with age 15 – 40 years who signed informed consent.
Ellis class 2 fracture
Class4 caries
|
|
| ExclusionCriteria |
| Details |
Discoloured tooth
Xerostomia
Pregnant women
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| there is significant difference in color difference |
there is significant difference in color difference within 28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| there is no significant difference in color |
7days,14 days, 28days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
30/12/2019 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
this randomized clinical trial tested color match between tooth remnant and composite of two different composite materials in class 4 restoration
patient diagnosed with ellis class 2 fracture or class 4 dental caries are included in this study.each class 4 was randomly assigned to one of the two treatment group based on the computer generated random number. The composite used were IPS EMPRESS , Filtek Z 250 . Colour change were evaluated using Spectrophotometer after 48 hrs, 7 days, 14 days and 28 days. |