| CTRI Number |
CTRI/2021/03/031659 [Registered on: 02/03/2021] Trial Registered Prospectively |
| Last Modified On: |
24/02/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluation and comparison of color match between tooth remnant and 2 types of tooth colored restorations in upper front teeth |
|
Scientific Title of Study
|
EVALUATION & COMPARISON OF COLOR MATCH BETWEEN THE TOOTH REMNANT & NANOFILLED / NANOHYBRID COMPOSITE RESINS IN CLASS IV RESTORATIONS: A RANDOMISED CONTROLLED TRIAL |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gagandeep Kaur Chadha |
| Designation |
Postgraduate student |
| Affiliation |
Vydehi Institute Of Dental Sciences & Research Centre Bangalore |
| Address |
Department of Conservative Dentistry & Endodontics,3rd year postgraduate, Room no 8, Vydehi Institute Of Dental Sciences & Research Centre, 82, EPIP area, Whitefield, Bangalore
Bangalore
KARNATAKA
560066
India |
| Phone |
09167575137 |
| Fax |
|
| Email |
gagan100214@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mohan Thomas Nainan |
| Designation |
Principal, Professor & Head of the Department |
| Affiliation |
Vydehi Institute Of Dental Sciences & Research Centre, Bangalore |
| Address |
Principal & Head of the Department, Department of Conservative Dentistry & Endodontics, Room no 8, Vydehi Institute Of Dental Sciences & Research Centre, 82, EPIP area, Whitefield, Bangalore 560066
Bangalore
KARNATAKA
560066
India |
| Phone |
09845255763 |
| Fax |
|
| Email |
drmohan27tn@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mohan Thomas Nainan |
| Designation |
Principal, Professor & Head of the Department |
| Affiliation |
Vydehi Institute Of Dental Sciences & Research Centre, Bangalore |
| Address |
Principal & Head of the Department, Department of Conservative Dentistry & Endodontics, Room no 8, Vydehi Institute Of Dental Sciences & Research Centre, 82, EPIP area, Whitefield, Bangalore 560066
Bangalore
KARNATAKA
560066
India |
| Phone |
09845255763 |
| Fax |
|
| Email |
drmohan27tn@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Dentsply India |
| Vydehi Institute of Dental Sciences & Research Centre, Bangalore |
|
|
Primary Sponsor
|
| Name |
Dr Gagandeep Kaur Chadha |
| Address |
Vaswani Bella Vista, Whitefield Bangalore |
| Type of Sponsor |
Other [Post graduate student] |
|
|
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 Mohan Thomas Nainan |
Vydehi Institute Of dental sciences & research centre, Bangalore |
Principal & Head of the Department, Department of Conservative Dentistry & Endodontics, Room no 8, Vydehi Institute Of Dental Sciences & Research Centre, 82, EPIP area, Whitefield, Bangalore 560066
Bangalore
KARNATAKA |
09845255763
drmohan27tn@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vydehi Institutional ethical board |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: K084||Partial loss of teeth, (2) ICD-10 Condition: K084||Partial loss of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nanofilled composite resin |
Color match between tooth and nanofilled composite restoration will be checked in intervals of time |
| Intervention |
Nanofilled/ Nanohybrid composite restoration |
Composite restoration alongwith tooth remnant will be measure for color differences |
| Comparator Agent |
Nanohybrid Composite resin |
Color match between tooth and nanohybrid composite restoration will be checked in intervals of time |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Patient willing to give written informed consent.
Adults in need of atleast one maxillary central incisor class IV restoration. |
|
| ExclusionCriteria |
| Details |
Non-vital tooth or tooth having peri-apical changes
Previous discolored Class IV restoration
Bleached tooth
Fixed Orthodontic appliance or fixed retainers on Central Incisor
Patients with parafunctional habits, deleterious habits |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| To measure the color differences occuring in tooth and nanofilled composite/nanohybrid restorations over time |
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Color differences in Nanofilled composite resin with nanohybrid composite resin |
1m onth |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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)
|
08/03/2021 |
| 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="1"
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)?
Response - NO
|
|
Brief Summary
|
The study is a double blinded randomised controlled trial, evaluating the color match of tooth remnant with nanofilled composite resin/ nanohybrid composite resin. In this study,32 Class IV restorations will be performed in maxillary central incisors using 2 groups of composite resins (group A-nanofilled, group B-nanohybrid). The patients will be selected as per the inclusion criteria, reporting to the department of Conservative Dentistry & Endodontics, Vydehi Dental Institute,Bangalore. Tooth remnant and the composite restoration will be evaluated in different time intervals: 10 minutes (baseline), 48 hours (before and after polishing), and 7,10, 14, and 28 days following placement of restoration. Quantitative analysis will be done by calculating the color difference (ΔE) values of the tooth remnant and the composite resins in each evaluation period. Qualitative analysis will be done using digital photographs’ scoring given by a neutral observer for both groups of restorations with respect to saturation, translucency and luminosity. |