| CTRI Number |
CTRI/2023/09/057973 [Registered on: 22/09/2023] Trial Registered Prospectively |
| Last Modified On: |
03/09/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of Flouroscence of restorative material |
|
Scientific Title of Study
|
Comparitive evaluation of Flouroscence of three different composite resins - an in vivo study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shivangi Trivedi |
| Designation |
Senior lecturer |
| Affiliation |
College of dental science and hospital rau indore |
| Address |
F12, Jhoomar Ghat, AB Rd, near Hotel Mashal,DEPT of conservative dentisry and endodontics, College of dental science and hospital Rau, Madhya
Pradesh 453331
Indore
MADHYA PRADESH
453331
India
Indore
MADHYA PRADESH
453331
India |
| Phone |
6263252310 |
| Fax |
|
| Email |
akashgroup91@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shivangi Trivedi |
| Designation |
Senior lecturer |
| Affiliation |
College of dental science and hospital rau indore |
| Address |
F12, Jhoomar Ghat, AB Rd, near Hotel Mashal,DEPT of conservative dentisry and endodontics, College of dental science and hospital Rau, Madhya
Pradesh 453331
Indore
MADHYA PRADESH
453331
India
MADHYA PRADESH
453331
India |
| Phone |
6263252310 |
| Fax |
|
| Email |
akashgroup91@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shivangi Trivedi |
| Designation |
Senior lecturer |
| Affiliation |
College of dental science and hospital rau indore |
| Address |
F12, Jhoomar Ghat, AB Rd, near Hotel Mashal,DEPT of conservative dentisry and endodontics, College of dental science and hospital Rau, Madhya
Pradesh 453331
Indore
MADHYA PRADESH
453331
India
MADHYA PRADESH
453331
India |
| Phone |
6263252310 |
| Fax |
|
| Email |
akashgroup91@gmail.com |
|
|
Source of Monetary or Material Support
|
| F12, Jhoomar Ghat, AB Rd, near Hotel Mashal,DEPT of conservative dentisry and endodontics, College of dental science and hospital Rau, Madhya
Pradesh 453331
Indore
MADHYA PRADESH
453331
India |
|
|
Primary Sponsor
|
| Name |
Dr Shivangi Trivedi |
| Address |
F12, Jhoomar Ghat, AB Rd, near Hotel Mashal, Rau, Madhya
Pradesh 453331
Indore
MADHYA PRADESH
453331
India |
| 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 |
| Dr Shivangi Trivedi |
College of dental science and hospital |
F12, Jhoomar Ghat, AB Rd, near Hotel Mashal,DEPT of conservative dentisry and endodontics, College of dental science and hospital Rau, Madhya
Pradesh 453331
Indore
MADHYA PRADESH
453331
India
Indore
MADHYA PRADESH |
6263252310
akashgroup91@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics commitee College of Dental Science and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Cervical abrasion |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Patients with cervical abrasion |
|
| ExclusionCriteria |
| Details |
Individuals with periodontal disease,
poor oral hygiene and any systemic disease or health condition that
hindered their participation were excluded from the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Omnichroma better than GC Essentia |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Omnichroma better than GC Essentia, Brilliant Flow |
3 months |
|
|
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)
|
01/07/2024 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Title: Comparative evaluation of fluorescence of three different composite resins – An in vivo study. Abstract: Background : Color matching between natural dentition and composite restorative materials is critical for esthetic restorations. However, materials of different brands, even of the same shade, vary not only in color but also in fundamental optical properties that influence the overall appearance of the restoration, such as translucency, opalescence and fluorescence. Aim: Aim of the study is to comparatively evaluate the fluorescence of threedifferent composite resins. Methodology: 15 patients with cervical abrasion in which restoration is indicated will be selected for this randomized clinical trial based in vivo study. Selected patients will then be divided into three equal groups according to the type of composite used to restore these cervical abrasion i.e, Brilliant flow , Omnichroma and GC essentia. After restoration, fluorescence intensity will be scored in numerical values and compared with natural enamel. The scored data will then be subjected for statistical analysis. Statistical analysis: Awaited |