Effect of Using Image Standardization Device for Dental Photography Standerdizatuon in Comparison to Individualized Photography In Vivo Study

This randomized clinical trial aimed to evaluate the effect of Image Standardization Device (ISD) on standardization of clinical images from the same entry point (patient right 45o).

Digital photography is highly important on multiple levels and has become associated with modern dentistry. Its application in dental practice is simple, quick, and extremely useful for procedures documentation, patient education, and conducting clinical research, resulting in several benefits for dentists in the terms of examination, diagnosis, treatment planning, progress and monitoring treatment outcomes. On the other hand, digital photography becomes significant tool for patient reassurance as showing before and after photos of several procedures helps in patient relaxation and understanding from the start, as well as improves the patient-dentist trust.

In the terms of producing decent digital dental photographs, standardization in several aspects of the photographic equipment, environment, and patient position become a critical issue for successful reproducible photographs.

Different standardization methods have been mentioned in the literature, some of them discussed the standardization characteristics in the terms of camera settings and adjustment using tripod only with standardized camera/patient distance, lighting, and background color. Other studies discussed standardization from a different point of view regarding the standardized patient head position and fixed camera/ patient distance using various devices slightly resembles the ISD used in this study.

The methodology of the current study included a total of twenty patients, photographed with ISD taking duplicate photographs and using individualized photography as a control group via conventional Tripod from the same photography point at 45º from the patient's right side to study the effect of the image standardization device in photograph standardization over conventional imaging methods. The Intervention used in this study was bleaching that was done before taking the same photographs once again from the same projections to reproduce the same images using both methods.

The assessment was done by measuring in millimeters the horizontal and vertical measurements of the canine in each patient by using a ruler tool on digital software and comparing them with the reference standard which was the canine's real measurements.

Study Overview

• Status: Completed
• Conditions: Digital Photography; Standardization; ISD
• Intervention / Treatment: Procedure: Bleaching

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt, 1234
    • Cairo university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Any patient with full set of anterior teeth willing to participate in the study in return to perform dental bleaching procedures

Exclusion Criteria:

• Patients with missing anterior teeth
• Patients with fillings in labial surface of anterior teeth
• Patients with prosthodontics in anterior teeth
• Patients with dental sensitivity
• Patients under 16 years old (bleaching age restrictions)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Patients

Procedure: Bleaching; Digital images for each patient will be taken once with the camera fixed on the classic tripod and again when the camera was fixed on the ISD , then horizontal and vertical measurements of the canines will be recorded by using a computer software on the digital images, then bleaching will be fine for all patients, then a second set of images will be taken again with the tripod and then with ISD, then measurements will be repeated and compared with the first set of images; Other Names: Image standardization; Tripod; ISD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Standardized digital imaging	Measuring tool is digital softwares to measure the length of the canine before and after bleaching process, from the images captured by the camera was fixed on the classic tripod or the images taken when the camera was fixed on the ISD , canine real measurements are the gold standard , the measuring unit is in millimeters	1 month

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2019
• Primary Completion (Actual): May 5, 2021
• Study Completion (Actual): June 7, 2021

Study Registration Dates

• First Submitted: July 14, 2021
• First Submitted That Met QC Criteria: August 3, 2021
• First Posted (Actual): August 5, 2021

Study Record Updates

• Last Update Posted (Actual): August 5, 2021
• Last Update Submitted That Met QC Criteria: August 3, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: oper 123

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No