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CTRI Number  CTRI/2025/03/081746 [Registered on: 06/03/2025] Trial Registered Prospectively
Last Modified On: 06/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Diagnostic 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   Intra-oral photography analysis between DSLR camera and smartphone camera 
Scientific Title of Study   Comparative evaluation of image quality, colour accuracy and resolution of intra-oral photographs made using a DSLR camera with macro lens and smartphone cameras 
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 Saif Momin 
Designation  2nd year Post-graduate 
Affiliation  Yenepoya dental college 
Address  Department of Prosthodontics, Yenepoya dental college, Derlakatte, Mangalore, 575018

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9922066339  
Fax    
Email  saifmomin88@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Hasan Sarfaraz 
Designation  Professor 
Affiliation  Yenepoya dental college 
Address  Department of Prosthodontics, Yenepoya Dental College, University Road, Derlakatte, Mangalore

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9845083778  
Fax    
Email  drhsarfaraz@yenepoya.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr Saif Momin 
Designation  2nd year Post-graduate 
Affiliation  Yenepoya dental college 
Address  Department of Prosthodontics, Yenepoya dental college, Derlakatte, Mangalore, 575018

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9922066339  
Fax    
Email  saifmomin88@gmail.com  
 
Source of Monetary or Material Support  
This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. 
 
Primary Sponsor  
Name  Dr Saif Momin 
Address  Flat no 203, Plama citius apartment, near yenepoya dental college, Derlakatte, Mangalore, India 575018 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Saif Momin  Yenepoya Dental college  Department of Prosthodontics, Crown and Bridge, Yenepoya University, University Road, Deralakatte, Mangaluru, Karnataka 575018
Dakshina Kannada
KARNATAKA 
9922066339

saifmomin88@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Yenepoya Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  We are only assessingimage quality, colour accuracy and resolution of intra-oral photographs made using a DSLR camera with macro lens and smartphone cameras. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  DSLR camera with macro lens  Nikon Z5 DSLR Camera with 100mm lens and Macro Twin lite MT-24EX  
Comparator Agent  Smartphone camera  I-phone 15 PRO Google Pixel 8 Samsung S24 Ultra 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Dentulous participants with a complete set of teeth.
Male and female participants within the 18-50 years age group.
Participants those who agree with the informed consent. 
 
ExclusionCriteria 
Details  Participants who do not provide informed consent 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Assessment of image quality, colour accuracy and resolution of intra-oral images between the two groups
photographs 
Immediately after obtaining images 
 
Secondary Outcome  
Outcome  TimePoints 
Assessment of resolution of intra-oral photographs between the two groups  Immediately after obtaining images 
 
Target Sample Size   Total Sample Size="10"
Sample Size from India="10" 
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)   17/03/2025 
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="4"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [saifmomin88@gmail.com].

  6. For how long will this data be available start date provided 07-10-2024 and end date provided 31-01-2025?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

NEED FOR THE STUDY:
Photography is a widely used medium for recording data in various fields including medicine and dentistry. The continuously evolving modern-day technology leads to a revolution in photographic standardization. Communication with lab technicians (shade matching, teeth selection), high-resolution pictures for research publications, patient education, and data recordings are some of the major applications of photography in the noble field of dentistry.
Nowadays, many clinicians prefer their smartphone cameras to record case, intra-oral and extra-oral pictures over DSLR cameras. Owing to the advantages like easy to handle, being cheap comparatively, and providing a wide range of editing options, there is still a big question mark on the accuracy, resolution, distortion and quality of the images captured using a smartphone device camera. Hence, in the evolving world of digitalization, there is a need for this study to know where the standard of mobile phone photography lies, and to what extent it can be used efficiently for recording intra-oral and extra-oral photographs in the field of dentistry.

RESEARCH QUESTION:
To assess the differences in image quality, distortion, magnification of images, colour accuracy, and resolution (in pixels per inch) of images captured by a DSLR camera set up for intraoral photography and different smartphone devices available currently in the market.

HYPOTHESIS (ALTERNATE/NULL): NULL HYPOTHESIS:
The null hypothesis states that there will be no difference in the image quality, distortion, magnification of images, colour accuracy, and resolution (in pixels per inch) of images captured by a DSLR camera set up for intraoral photography and, iPhone 15 PRO smartphone camera, a Google Pixel 8 smartphone camera and Samsung S24 ultra smartphone device camera.

AIM:
The study aims to compare the image quality, distortion, magnification of images, colour accuracy, and resolution (in pixels per inch) of images captured by a DSLR camera set up for intraoral photography, an iPhone 15 PRO smartphone camera, a Google Pixel 8 smartphone camera and Samsung S24 ultra smartphone camera under optimal light conditions.

OBJECTIVES:

1.      To evaluate and compare the distortion of the image by measuring the dimensions of the Maxillary Central incisor (height* width) captured by a DSLR Camera, iPhone 15 Pro, Google Pixel 8 and a Samsung S24 Ultra smartphone device.

2.      To evaluate and compare the extra-oral magnification of the image by measuring the inter-canthal distance from the image captured using a DSLR camera, iPhone 15 Pro, Google Pixel 8 and a Samsung S24 Ultra smartphone device.

3.      To evaluate and compare the intra-oral magnification of the image by measuring the inter-canine distance from the image captured using a DSLR camera, iPhone 15 Pro, Google Pixel 8 and a Samsung S24 Ultra smartphone device.

4.      To evaluate and compare the colour of teeth using the HSV (Hue, saturation, value) values for the maxillary central incisor through an image captured via DSLR camera, iPhone 15 Pro, Google Pixel 8 and a Samsung S24 Ultra smartphone device.

5.      To evaluate and compare the picture resolution obtained in pixels per inch (PPI) for images captured using a DSLR camera, iPhone 15 Pro, Google Pixel 8 and a Samsung S24 Ultra smartphone device.

 

METHODOLOGY:

STUDY DESIGN: Cross-sectional study design.

STUDY SITE: Department of Prosthodontics, Crown and Bridge, Yenepoya Dental

College, Mangalore.

FUNDING DETAILS: Self-funded

STUDY DURATION: 2 months. (October-November 2024)

 

SOURCE OF DATA:

·        Out-patient department of Yenepoya Dental College, Mangalore.

·        After selecting the participants, they will be informed about the study details in the language they understand. (Annexure I)

·        Participants will be asked to sign the consent letter of participation. (Annexure 4).

 

SAMPLE SIZE:

Using G* Power software, under ANOVA, it is suggested to collect data from 10 patients with 4 measurements in each patient (10*4=40) at 95% confidence level and 80% power. The effect size=0.5621 is calculated using mean and standard deviations reported in the literature by Saincher R et al. (2022). [3]

 

METHOD OF SAMPLING (SAMPLING TECHNIQUE):

Convenience sampling method.

 

INCLUSION CRITERIA:

1.      Dentulous participants with a complete set of teeth

2.      Male and female participants within the 18-50 years age group.

3.      Participants those who agree with the informed consent.

 

EXCLUSION CRITERIA

Participants with prosthetic rehabilitation in the anterior tooth region, and ongoing orthodontic treatment.

Participants with malocclusion anomalies like crowding of teeth, rotation and spacing of teeth.

WITHDRAWAL CRITERIA

Participants have the right to withdraw from the study at any time.

 

DISCONTINUATION CRITERIA

Participants having any kind of identity issues with their photographs may be included in the discontinuation criteria.

 

STUDY TOOL:

Static photographic records

 

DESCRIPTION (QUESTIONNAIRE; INTERVIEW SCHEDULE; SCALES; SCORES; DATA COLLECTION FORM; PROFORMA; ETC)

Data collection form.

METHOD:

DETAILS OF THE METHODOLOGY INCLUDING DETAILS OF SAMPLE COLLECTION:

A. Materials and Armamentarium

Armamentarium:

Nikon Z50 HDSLR Camera with 100mm lens and Macro Twin lite MT-24EX

I-phone 15 PRO

Google Pixel 8 smartphone

Samsung S24 Ultra

 

Materials:

Cheek retractors

Black contrastor

Black chart paper

Intra-oral mirror

Methodology:

Participants will be recruited from the outpatient department of Yenepoya Dental College. An informed consent sheet and participant information sheet will be provided and the study procedure will be explained to them prior.

 

Study groups:

Control group: Nikon Z5 DSLR with 105mm macro-lens and Twin lite MT-24EX flash.

Case group:

Group 1) iPhone 15 pro smartphone.

Group 2) Google Pixel 8 smartphone.

Group 3) Samsung S24 Ultra smartphone.

 

Pictorial records: 5 sets of images per participant.

1. Maximum Intercuspation image

2. Anterior teeth with black contrast image

3. Right lateral occlusion image

4. Mandibular occlusal view using intra-oral mirror

5. Extra-oral portrait image

Method: the participant is seated on a dental chair; informed consent is provided.

A plastic cheek retractor is used to provide sufficient retraction, and isolation is done with

suction tips.

Intraoral mirrors are used to record the images.

5 sets of images are captured for a participant per group.

Light conditions are standardized as daylight conditions.

DSLR Camera with a 100mm macro lens is used as the control group, the device is used at a faster shutter speed (200), longer focal length (f/25), magnification of 1:2 and higher aperture size for intra-oral pictures.

For extra-oral portrait pictures, the DSLR camera is set at shutter speed (60), focal length(f/10), and magnification ratio of 1:10.

The mobile phone groups (iPhone, Google Pixel 8 and Samsung S24 ultra) are used in auto-focus mode, at a standardized zoom(2x) and equal focal length (25cm) for all the groups.

Each intra-oral image is cropped (4:3) and the extra-oral image (3:4) in JPEG file format is uploaded to a secured folder in the investigator’s laptop for data analysis.

 

Data measurement:

Distortion of the image will be evaluated in the Maximum intercuspation image by measuring the dimensions (height in mm) of the maxillary right central incisor using digital software GIMP Version 2.1 for the control and case group.

Extra-oral Magnification will be checked by measuring the intercanthal distance (in mm) for each frontal view image captured in portrait mode using the same software.

Intra-oral Magnification will be evaluated by measuring inter-canine width (in mm) in the mandibular occlusal view picture for each participant.

The resolution of the image will be measured in DPI (dots per inch) in the Right lateral occlusion picture using GIMP 2.1 software.

Shade evaluation: manual method:

The anterior teeth with black contrastor image will be used.

The shade of anterior teeth (preferably Maxillary right Canine) in all the test-group images will be compared with the control group by the investigator.

HSV values will be obtained using digital software (GIMP 2.1) for better correlation with the colour of the selected tooth.

All the readings obtained from the pictures will be stored efficiently in a data collection sheet (Microsoft Excel) for further statistical analysis.

 

DETAILS OF ANALYSIS: (Including statistical tests):

Data points will be coded in MS Excel and all statistical analysis will be done using IBM SPSS 27 software.

The Shapiro-Wilk test will be used to check the normality.

The summary of quantitative variables will be presented using counts, mean or median and standard deviation/interquartile range depending on normality.

The significant difference between the four groups of measurements will be assessed through one-way ANOVA or the Kruskal Walli test depending on normality. If the null hypothesis is rejected, then post hoc tests are to be carried out for pair-wise comparisons.

 
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