Dental AnxietyNCT06623851
Digital Versus Conventional Impression on Discomfort and Dental Anxiety Among Preschoolers
A study testing Intraoral scanner and Alginate impression in people with Dental Anxiety, run by Hams Hamed Abdelrahman at 1 site in Egypt.
Trial summary
Background: Taking alginate impressions for preschoolers is challenging and might be disturbing for them. Therefore, intraoral scanners are suggested as a better alternative to the conventional alginate impression. Read more about this study
- Who is it for?
- Ages 4 to 6 years
- Conditions the study is for
- Dental Anxiety
- What is being tested?
- Intraoral scanner and Alginate impression
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteEgypt
- Study dates
- 23 Jun 2024to 1 Oct 2024
- 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 4 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with scores of 3 or 4 during preoperative assessments according to the Frankl Behavioral Rating Scale.
- No previous dental experience.
- Patient's parents signed an informed consent before participating in the trial.
Who cannot join
- Any physical or mental disability, or psychological problems.
- Children with temporomandibular joint or periodontal discomfort
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Alexandria Faculty of Dentistry
Alexandria
Arwa Ghoneim, BDS, 01204666655, arwaghoneim1992@gmail.com
Arwa Gohneim, BDS
About this study
Official title: Effectiveness of Digital Versus Conventional Impression on Discomfort and Dental Anxiety in Preschool Children (A Randomized Controlled Clinical Trial)
Background: Taking alginate impressions for preschoolers is challenging and might be disturbing for them. Therefore, intraoral scanners are suggested as a better alternative to the conventional alginate impression.
Objectives: The present study aims to evaluate and compare the level of patients' discomfort, dental anxiety, gag reflex, behavior and time required for taking alginate impressions with that of intraoral scanning.
Materials and methods: The study will be a randomized, controlled clinical trial, parallel design. A total of 666 pediatric dental patients aged from 4-6 years will be selected from the outpatient clinic of the of Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Alexandria University. Participants will be allocated into 2 groups. Children in the first group will receive digital impressions by an intraoral scanner, while those of the second group will receive conventional alginate impressions. Patients' discomfort will be evaluated by a modified VAS index supported with emojis. Dental anxiety will be evaluated using Facial Image Scale (FIS). Gag reflex will be assessed by Gag Severity Index (GSI). Child's behavior towards the impression technique in the 2 groups will be evaluated using Venham's Behavior rating scale. Time taken to complete the procedures will be recorded using a digital stopwatch.
- Conditions
- Dental Anxiety
- Being tested
- Intraoral scanner, Alginate impression
- Keywords
- Dental impression, Digital impression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoral scannerOther
- The digital impressions will be made with the intraoral scanner following the procedure reported by the manufacturer.
- The intraoral scanning process is divided into the lower jaw scan, upper jaw scan, and bite scan stages
Alginate impressionOther
Conventional impressions of both arches will be made according to the manufacturer's instructions, using steel impression trays and alginate
| Study group | Role | What they receive |
|---|---|---|
| Digital dental Impression | Experimental | Not described Receives: Other: Intraoral scanner |
| Conventional dental impression | Active comparator | Not described Receives: Other: Alginate impression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in child discomfort
Children's discomfort will be evaluated using a 100-mm modified VAS index supported with facial emojis.
Measured: intraoperative
Change in dental anxiety
Dental anxiety will be recorded using the Facial Image Scale (FIS) Children will be asked to indicate which of the faces they feel most like at that moment, it is a 'state' measure of anxiety that provides an immediate reflection of how the child is feeling.
Measured: intraoperative
Secondary outcomes (3)
Gag reflex
After taking the impressions, child's gag reflex will be assessed. Gag sensitivity is ranked on a scale from 1 (least severe) to 5 (most severe) using the Gagging Severity Index (GSI)
Measured: post procedure
Assessment of level of child cooperation
Venham's Behavior rating scale classifies the child's behavior into 6 categories with scores ranging from 0 to 5. A score of 0 means total cooperation and a score of 5 refers to complete absence of compliance and cooperation and the requirement of physical restraint
Measured: intraoperative
procedure time
Time taken from scanning and taking impression for the lower and upper jaws to the final bite registeration. Time will be recorded in minutes
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2024
- Study start23 Jun 2024
- Primary completion29 Sep 2024 (estimated)
- Study completion1 Oct 2024 (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 Dental AnxietyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hams Hamed Abdelrahman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hams Hamed Abdelrahman, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06623851
- Sponsor's protocol ID
- 0863-2/2024
- Status last verified
- Oct 2024
- First submitted
- 25 Jul 2024
- Last updated
- 2 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ghoneim AM, Dowidar KML, Talaat DM. Effectiveness of Digital Versus Conventional Impression on Discomfort and Dental Anxiety in Preschool Children (Randomised Controlled Clinical Trial). Int J Paediatr Dent. 2026 Jul;36(4):540-548. doi: 10.1111/ipd.70088. Epub 2026 Mar 31.
PubMed 41917676
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Digital Versus Conventional Impression on Discomfort and Dental Anxiety in Preschool Children (A Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT06623851
- Acronym / sponsor ID
- 0863-2/2024
- Conditions
- Dental Anxiety
- Keywords
- Dental impression, Digital impression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Hams Hamed AbdelrahmanUniversity, hospital or other
- Study start
- 23 Jun 2024 (actual)
- Primary completion
- 29 Sep 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 2 Oct 2024 (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.
Background: Taking alginate impressions for preschoolers is challenging and might be disturbing for them. Therefore, intraoral scanners are suggested as a better alternative to the conventional alginate impression.
Objectives: The present study aims to evaluate and compare the level of patients' discomfort, dental anxiety, gag reflex, behavior and time required for taking alginate impressions with that of intraoral scanning.
Materials and methods: The study will be a randomized, controlled clinical trial, parallel design. A total of 666 pediatric dental patients aged from 4-6 years will be selected from the outpatient clinic of the of Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Alexandria University. Participants will be allocated into 2 groups. Children in the first group will receive digital impressions by an intraoral scanner, while those of the second group will receive conventional alginate impressions. Patients' discomfort will be evaluated by a modified VAS index supported with emojis. Dental anxiety will be evaluated using Facial Image Scale (FIS). Gag reflex will be assessed by Gag Severity Index (GSI). Child's behavior towards the impression technique in the 2 groups will be evaluated using Venham's Behavior rating scale. Time taken to complete the procedures will be recorded using a digital stopwatch.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digital dental Impression | Experimental | Other: Intraoral scanner |
| Conventional dental impression | Active comparator | Other: Alginate impression |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children with scores of 3 or 4 during preoperative assessments according to the Frankl Behavioral Rating Scale.
- No previous dental experience.
- Patient's parents signed an informed consent before participating in the trial.
Key exclusion criteria (2 listed)
- Any physical or mental disability, or psychological problems.
- Children with temporomandibular joint or periodontal discomfort
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 scanner* The digital impressions will be made with the intraoral scanner following the procedure reported by the manufacturer. * The intraoral scanning process is divided into the lower jaw scan, upper jaw scan, and bite scan stages | Other | Digital dental Impression |
| Alginate impressionConventional impressions of both arches will be made according to the manufacturer's instructions, using steel impression trays and alginate | Other | Conventional dental impression |
Primary outcome
Change in child discomfort
Time frame: intraoperative
Children's discomfort will be evaluated using a 100-mm modified VAS index supported with facial emojis.
Change in dental anxiety
Time frame: intraoperative
Dental anxiety will be recorded using the Facial Image Scale (FIS) Children will be asked to indicate which of the faces they feel most like at that moment, it is a 'state' measure of anxiety that provides an immediate reflection of how the child is feeling.
3 secondary outcomes
Gag reflex
Time frame: post procedure
Assessment of level of child cooperation
Time frame: intraoperative
procedure time
Time frame: intraoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
- Derived from this study: PubMed 41917676Ghoneim AM, Dowidar KML, Talaat DM. Effectiveness of Digital Versus Conventional Impression on Discomfort and Dental Anxiety in Preschool Children (Randomised Controlled Clinical Trial). Int J Paediatr Dent. 2026 Jul;36(4):540-548. doi: 10.1111/ipd.70088. Epub 2026 Mar 31.
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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.
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 scanner and Alginate impression in people with Dental Anxiety, run by Hams Hamed Abdelrahman 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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 2 Oct 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Arwa Ghoneim, BDS (01204666655, arwaghoneim1992@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in child discomfort (time frame: intraoperative). The study lists 2 primary outcomes in all. 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 NCT06623851, 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 2 Oct 2024.