Digital PhotographyNCT04991363
Effect of Using Image Standardization Device for Dental Photography Standerdizatuon in Comparison to Individualized Photography In Vivo Study
A study testing Bleaching in people with Digital Photography and Standardization, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Digital Photography, Standardization, ISD
- What is being tested?
- Bleaching
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Jul 2019to 7 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Any patient with full set of anterior teeth willing to participate in the study in return to perform dental bleaching procedures
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this 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.
Read more
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.
- Conditions
- Digital Photography, Standardization, ISD
- Being tested
- Bleaching
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BleachingProcedure or surgery
Also called Image standardization, Tripod, ISD
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
| Study group | Role | What they receive |
|---|---|---|
| Patients | Experimental | Not described Receives: Procedure: Bleaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2021
- Study start5 Jul 2019
- Primary completion5 May 2021
- Study completion7 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Digital PhotographyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nourhan Ashraf Abou-Bakr, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04991363
- Sponsor's protocol ID
- oper 123
- Status last verified
- Aug 2021
- First submitted
- 14 Jul 2021
- Last updated
- 5 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Using Image Standardization Device for Dental Photography Standerdizatuon in Comparison to Individualized Photography In Vivo Study
- ClinicalTrials.gov ID
- NCT04991363
- Acronym / sponsor ID
- oper 123
- Conditions
- Digital Photography, Standardization, ISD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 5 Jul 2019 (actual)
- Primary completion
- 5 May 2021 (actual)
- Study completion
- 7 Jun 2021 (actual)
- First posted
- 5 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | Procedure: Bleaching |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Any patient with full set of anterior teeth willing to participate in the study in return to perform dental bleaching procedures
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BleachingAlso: Image standardization, Tripod, ISDDigital 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 | Procedure or surgery | Patients |
Primary outcome
Standardized digital imaging
Time frame: 1 month
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Digital Photography
Not yet recruitingObservational study
Skin-in-Sight: a Longitudinal Cohort Infrastructure for Standardized Remote Monitoring and the Evaluation of Digital Care Innovations in Chronic Skin Diseases
Psoriasis, Eczema/Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bleaching in people with Digital Photography and Standardization, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standardized digital imaging (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2021.