Pediatric Patient With Early Loss of Primary TeethNCT06833385
Comparative Evaluation of Pediatric Patient Comfort, Time, and Preference Between Digital Scans and Rubber Base Impressions. Crossover Study Randomized Controlled Trial
A study testing Intraoral Scanning and PVS Impression in people with Pediatric Patient With Early Loss of Primary Teeth, run by Yasmine Ahmed Mortada Abd Elfatah at 1 site in Egypt.
Trial summary
The comfort of impression methods and the time they require are important because it is known that children are more stressed in their encounter with the dentist than the elderly, and their chairside times are shorter. Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- Pediatric Patient With Early Loss of Primary Teeth
- What is being tested?
- Intraoral Scanning and PVS Impression
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2025to 1 Apr 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 6 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- cooperative healthy 6-11 years old child
Who cannot join
- uncooperative with experience with technique
Trial locations and contacts
1 site in 1 country.
About this study
The comfort of impression methods and the time they require are important because it is known that children are more stressed in their encounter with the dentist than the elderly, and their chairside times are shorter. The comparison of impression methods in terms of comfort, preference, and time has been studied only in young adults or adult patients. thus this study will assess pediatric patient comfort, time, and preference between digital scans and rubber base impressions.
- Being tested
- Intraoral Scanning, PVS Impression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoral ScanningDiagnostic test
Participants will first undergo intraoral scanning using a digital scanner to capture a 3D image of their dental arches. The procedure is non-invasive and requires no impression material. After one week, the same participants will undergo a polyvinyl siloxane (PVS) impression using conventional impression trays and materials
PVS ImpressionDiagnostic test
Participants will first undergo a polyvinyl siloxane (PVS) impression, where an impression tray filled with PVS material is used to capture the shape of their dental arches. After one week, the same participants will undergo intraoral scanning using a digital scanner for a 3D image of their dentition.
| Study group | Role | What they receive |
|---|---|---|
| Intraoral Scanning First, PVS Impression Second | Experimental | Not described Receives: Diagnostic Test: Intraoral Scanning; Diagnostic Test: PVS Impression |
| PVS Impression First, Intraoral Scanning Second | Experimental | Not described Receives: Diagnostic Test: Intraoral Scanning; Diagnostic Test: PVS Impression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Preference for Impression Technique
Measured: Immediately after the second impression (within the same visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study start1 Feb 2025
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pediatric Patient With Early Loss of Primary TeethStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yasmine Ahmed Mortada Abd Elfatah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yasmine Ahmed Mortada Abd Elfatah, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06833385
- Sponsor's protocol ID
- 17-2025-0002
- Status last verified
- Feb 2025
- First submitted
- 13 Feb 2025
- Last updated
- 18 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to patient confidentiality concerns and ethical considerations. The collected data is specific to the study objectives and not intended for
Publications
Gamal AM, Abd Elfatah YAM. Comparative evaluation of pediatric patient comfort, time, and preference between digital scans and rubber base impressions: crossover study randomized controlled trial. BMC Oral Health. 2025 Dec 14;25(1):1899. doi: 10.1186/s12903-025-07192-8.
PubMed 41392143
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Pediatric Patient Comfort, Time, and Preference Between Digital Scans and Rubber Base Impressions. Crossover Study Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06833385
- Acronym / sponsor ID
- 17-2025-0002
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Yasmine Ahmed Mortada Abd ElfatahUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 18 Feb 2025 (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.
The comfort of impression methods and the time they require are important because it is known that children are more stressed in their encounter with the dentist than the elderly, and their chairside times are shorter. The comparison of impression methods in terms of comfort, preference, and time has been studied only in young adults or adult patients. thus this study will assess pediatric patient comfort, time, and preference between digital scans and rubber base impressions.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intraoral Scanning First, PVS Impression Second | Experimental | Diagnostic Test: Intraoral Scanning, Diagnostic Test: PVS Impression |
| PVS Impression First, Intraoral Scanning Second | Experimental | Diagnostic Test: Intraoral Scanning, Diagnostic Test: PVS Impression |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- cooperative healthy 6-11 years old child
Key exclusion criteria (1 listed)
- uncooperative with experience with technique
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 |
|---|---|---|
| Intraoral ScanningParticipants will first undergo intraoral scanning using a digital scanner to capture a 3D image of their dental arches. The procedure is non-invasive and requires no impression material. After one week, the same participants will undergo a polyvinyl siloxane (PVS) impression using conventional impression trays and materials | Diagnostic test | Intraoral Scanning First, PVS Impression Second, PVS Impression First, Intraoral Scanning Second |
| PVS ImpressionParticipants will first undergo a polyvinyl siloxane (PVS) impression, where an impression tray filled with PVS material is used to capture the shape of their dental arches. After one week, the same participants will undergo intraoral scanning using a digital scanner for a 3D image of their dentition. | Diagnostic test | Intraoral Scanning First, PVS Impression Second, PVS Impression First, Intraoral Scanning Second |
Primary outcome
Patient Preference for Impression Technique
Time frame: Immediately after the second impression (within the same visit)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2025.
- Derived from this study: PubMed 41392143Gamal AM, Abd Elfatah YAM. Comparative evaluation of pediatric patient comfort, time, and preference between digital scans and rubber base impressions: crossover study randomized controlled trial. BMC Oral Health. 2025 Dec 14;25(1):1899. doi: 10.1186/s12903-025-07192-8.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to patient confidentiality concerns and ethical considerations. The collected data is specific to the study objectives and not intended for
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 Intraoral Scanning and PVS Impression in people with Pediatric Patient With Early Loss of Primary Teeth, run by Yasmine Ahmed Mortada Abd Elfatah 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 1 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: under way, not looking for participants, as of the sponsor's last update on 18 Feb 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Patient Preference for Impression Technique (time frame: Immediately after the second impression (within the same visit)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06833385, which also lists 1 linked publication.
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 18 Feb 2025.