NCT04991363

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 5, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 7, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 14, 2021

Completed
22 days until next milestone

First Posted

Study publicly available on registry

August 5, 2021

Completed
Last Updated

August 5, 2021

Status Verified

August 1, 2021

Enrollment Period

1.8 years

First QC Date

July 14, 2021

Last Update Submit

August 3, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Patients

EXPERIMENTAL
Procedure: Bleaching

Interventions

BleachingPROCEDURE

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

Also known as: Image standardization, Tripod, ISD
Patients

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Giza, 1234, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

July 14, 2021

First Posted

August 5, 2021

Study Start

July 5, 2019

Primary Completion

May 5, 2021

Study Completion

June 7, 2021

Last Updated

August 5, 2021

Record last verified: 2021-08

Locations