| CTRI Number |
CTRI/2024/07/070002 [Registered on: 04/07/2024] Trial Registered Prospectively |
| Last Modified On: |
02/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparing mobile phone and DSLR camera against digital machine for selecting the color of tooth |
|
Scientific Title of Study
|
Comparative evaluation of the efficacy of smartphone and DSLR camera in selecting the shade of tooth against intraoral scanner : An observational 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 |
Namita Rajesh Zilpilwar |
| Designation |
Post graduate student |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
202 Department of prosthodontics crown and bridge , sharad pawar dental college and hospital , sawangi, wardha442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
8669110902 |
| Fax |
|
| Email |
namitazilpilwar98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sharayu Nimonkar |
| Designation |
Associate professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
202 Department of prosthodontics crown and bridge , sharad pawar dental college and hospital , sawangi, wardha442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
8830977678 |
| Fax |
|
| Email |
snimonkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sharayu Nimonkar |
| Designation |
Associate professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
202 Department of prosthodontics crown and bridge , sharad pawar dental college and hospital , sawangi, wardha442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
8830977678 |
| Fax |
|
| Email |
snimonkar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research |
| Address |
Sawangi, Meghe, Wardha 442001 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Namita Rajesh Zilpilwar |
Datta Meghe Institute of Higher Education and Research |
202 Department of Prosthodontics and Crown & Bridge Sharad Pawar Dental College and Hospital ,Datta Meghe Institute of Higher Education and Research, Sawangi ,Wardha ,Maharashtra, India 442001.
Wardha
MAHARASHTRA |
8669110902
namitazilpilwar98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Datta Meghe Institute of Higher Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Completely dentulous patients |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Anterior maxillary teeth.
Co-operative patients
Patient who are willing to participate in the study.
|
|
| ExclusionCriteria |
| Details |
Teeth having any abrasion.
Teeth with enamel anomalies.
Adjacent teeth with crown prosthesis.
Teeth with calculus and stains(extrinsic and intrinsic).
Root canal treated teeth.
Teeth having any restorations.
Fractured tooth ( vertical and horizontal).
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To introduce new, user friendly, non technique sensitive, readily available,economic device in the field of dentistry for shade selection.
|
assessment will be done in 4 weeks of time period
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NA |
|
|
Target Sample Size
|
Total Sample Size="221"
Sample Size from India="221"
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)
|
25/07/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
AIM -Comparative evaluation of the efficacy of smartphone and DSLR camera in selecting the shade of tooth against Intraoral scanner. : An observational study BACKGROUND- The increasing esthetic needs of patients require increased competence in tooth shade determination so tools used for shade matching are developing continuously.Color perception is a complicated phenomenon and is affected by several factors, including incident light, light reflection, light absorption, observer’s visual matching, and the object’s surrounding environment.
METHODS AND MATERIAL -The observational study will be conducted in the department of prosthodontics and crown & bridge. Total 221 subjects will be selected from patients coming to out patients department (OPD) of prosthodontics and crown & bridge. Informed consent will be taken from subjects. Subjects will be screened those fulfills the inclusion criteria and exclusion criteria . Further clearing IEC studied subjects will be exposed to an Intraoral scanner, smartphone and DSLR for its shade selection. EXPECTED OUTCOME To introduce new, user friendly, non technique sensitive, readily available,economic device in the field of dentistry for shade selection.
|