Dental ImpressionsNCT06948617
Children's Preferences on Digital and Conventional Impression Techniques
A study testing digital intraoral scanner and Alginate Impression in people with Dental Impressions, run by Uşak University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this crossover study is to compare children's perceptions and preferences regarding digital and conventional impression techniques in the 5- to 11-year-old age group. Read more about this study
- Who is it for?
- Ages 5 to 11 years
- Conditions the study is for
- Dental Impressions
- What is being tested?
- digital intraoral scanner and Alginate Impression
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2023to 15 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 5 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- No prior exposure to either digital or conventional impression techniques
- Absence of temporomandibular joint disorders and periodontal disease
- Cleft lip and/or palate, or other significant craniofacial anomalies
- No current use of psychiatric or neuropathic medications
Who cannot join
- Individuals with a known history of dental anxiety or a pronounced gag reflex
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Usak University School of Dentistry, Department of Pediatric Dentistry
Uşak, 64200
About this study
Official title: Digital and Conventional Impression Techniques: What Influences Children's Preferences?
The goal of this crossover study is to compare children's perceptions and preferences regarding digital and conventional impression techniques in the 5- to 11-year-old age group. The main questions it aims to answer are
- Which impression methods do kids prefer?
- What influences kids' perception of impression methods?
Dental impressions will be obtained using both the conventional alginate impression (CAI) (Cavex ColorChange; Cavex Holland BV, Haarlem, the Netherlands) and digital intraoral scanning procedure (DIS) (3Shape TRIOS Color, 3Shape, Copenhagen, Denmark). After each procedure, patients will score their perceptions using a Modified Impression Perception Test, a 5-point Likert scale, for gag reflex, queasiness, difficulty breathing, uncomfortable feeling, pain perception, chairside time, and stress levels. Dental anxiety will be assessed using the Visual Anxiety Scale (1-10). Children will also be asked about their preferences and reasons in one or two sentences. Content analysis will be performed on answers to open-ended questions. Statistical analysis will be done using Fisher's Exact test.
- Conditions
- Dental Impressions
- Being tested
- digital intraoral scanner, Alginate Impression
- Keywords
- dental impression, digital intraoral scanner, alginate, children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
digital intraoral scannerDevice
Alginate impressions were obtained with an irreversible hydrocolloid impression material (Cavex Impressional; Cavex Holland, Haarlem, The Netherlands) and standard plastic trays. For each impression, the time required to mix the material and complete a full-mouth (maxillary and mandibular arches) impression was recorded.
Alginate ImpressionDevice
Alginate impressions were obtained with an irreversible hydrocolloid impression material (Cavex Impressional; Cavex Holland, Haarlem, The Netherlands) and standard plastic trays. For each impression, the time required to mix the material and complete a full-mouth (maxillary and mandibular arches) impression was recorded.
| Study group | Role | What they receive |
|---|---|---|
| children aged between 5-11 who need space maintainer or orthodontic treatments | Experimental | Not described Receives: Device: digital intraoral scanner; Device: Alginate Impression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Children Perception test
After the each impression proscedure, to evaluate children's perspectives on the impression techniques, the perception questionnaire used in Burhardt's study was adapted for this research.5 The questionnaire was translated into Turkish to ensure cultural and linguistic appropriateness. The translated version underwent content validation through expert review to ensure its relevance and appropriateness for the target population. The perception questionnaire used in this study aimed to measure gag reflex, queasiness, difficulty to breathe, discomfort, time perception, stress, pain. Accordingly, 8 questions with 5-point Likert scale responses ranging from "strongly agree" to "strongly disagree" were included (Figure-1). Additionally, the Visual Anxiety Scale (VAS) was employed to measure overall discomfort. For the VAS results, children were asked to score their perceived discomfort on a scale from 0 (no discomfort) to 10 (extreme discomfort).
Measured: one year
Secondary outcomes (1)
Responses to open-ended questions
After completing both of the impression proscedure, children were asked two questions regarding their preference: one closed-ended question "Which method did you prefer?" and one open-ended follow-up question "Why did you prefer this method?". The latter was used for thematic content analysis.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2025
- Study start15 Jan 2023
- Primary completion15 Jun 2024
- Study completion15 Oct 2024
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 ImpressionsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uşak University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06948617
- Sponsor's protocol ID
- 333-333-11
- Status last verified
- Apr 2025
- First submitted
- 21 Apr 2025
- Last updated
- 2 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data includes personel data of the participants.
Publications
Yilmaz H, Aydin MN. Digital versus conventional impression method in children: Comfort, preference and time. Int J Paediatr Dent. 2019 Nov;29(6):728-735. doi: 10.1111/ipd.12566. Epub 2019 Aug 13.
PubMed 31348834
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital and Conventional Impression Techniques: What Influences Children's Preferences?
- ClinicalTrials.gov ID
- NCT06948617
- Acronym / sponsor ID
- 333-333-11
- Conditions
- Dental Impressions
- Keywords
- dental impression, digital intraoral scanner, alginate, children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Uşak UniversityUniversity, hospital or other
- Study start
- 15 Jan 2023 (actual)
- Primary completion
- 15 Jun 2024 (actual)
- Study completion
- 15 Oct 2024 (actual)
- First posted
- 29 Apr 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 goal of this crossover study is to compare children's perceptions and preferences regarding digital and conventional impression techniques in the 5- to 11-year-old age group. The main questions it aims to answer are
- Which impression methods do kids prefer?
- What influences kids' perception of impression methods?
Dental impressions will be obtained using both the conventional alginate impression (CAI) (Cavex ColorChange; Cavex Holland BV, Haarlem, the Netherlands) and digital intraoral scanning procedure (DIS) (3Shape TRIOS Color, 3Shape, Copenhagen, Denmark). After each procedure, patients will score their perceptions using a Modified Impression Perception Test, a 5-point Likert scale, for gag reflex, queasiness, difficulty breathing, uncomfortable feeling, pain perception, chairside time, and stress levels. Dental anxiety will be assessed using the Visual Anxiety Scale (1-10). Children will also be asked about their preferences and reasons in one or two sentences. Content analysis will be performed on answers to open-ended questions. Statistical analysis will be done using Fisher's Exact test.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| children aged between 5-11 who need space maintainer or orthodontic treatments | Experimental | Device: digital intraoral scanner, Device: Alginate Impression |
Who may qualify
- Ages
- 5 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- No prior exposure to either digital or conventional impression techniques
- Absence of temporomandibular joint disorders and periodontal disease
- Cleft lip and/or palate, or other significant craniofacial anomalies
- No current use of psychiatric or neuropathic medications
Key exclusion criteria (1 listed)
- Individuals with a known history of dental anxiety or a pronounced gag reflex
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 |
|---|---|---|
| digital intraoral scannerAlginate impressions were obtained with an irreversible hydrocolloid impression material (Cavex Impressional; Cavex Holland, Haarlem, The Netherlands) and standard plastic trays. For each impression, the time required to mix the material and complete a full-mouth (maxillary and mandibular arches) impression was recorded. | Device | children aged between 5-11 who need space maintainer or orthodontic treatments |
| Alginate ImpressionAlginate impressions were obtained with an irreversible hydrocolloid impression material (Cavex Impressional; Cavex Holland, Haarlem, The Netherlands) and standard plastic trays. For each impression, the time required to mix the material and complete a full-mouth (maxillary and mandibular arches) impression was recorded. | Device | children aged between 5-11 who need space maintainer or orthodontic treatments |
Primary outcome
Modified Children Perception test
Time frame: one year
After the each impression proscedure, to evaluate children's perspectives on the impression techniques, the perception questionnaire used in Burhardt's study was adapted for this research.5 The questionnaire was translated into Turkish to ensure cultural and linguistic appropriateness. The translated version underwent content validation through expert review to ensure its relevance and appropriateness for the target population. The perception questionnaire used in this study aimed to measure gag reflex, queasiness, difficulty to breathe, discomfort, time perception, stress, pain. Accordingly, 8 questions with 5-point Likert scale responses ranging from "strongly agree" to "strongly disagree" were included (Figure-1). Additionally, the Visual Anxiety Scale (VAS) was employed to measure overall discomfort. For the VAS results, children were asked to score their perceived discomfort on a scale from 0 (no discomfort) to 10 (extreme discomfort).
1 secondary outcome
Responses to open-ended questions
Time frame: one year
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 2 May 2025.
- Background: PubMed 31348834Yilmaz H, Aydin MN. Digital versus conventional impression method in children: Comfort, preference and time. Int J Paediatr Dent. 2019 Nov;29(6):728-735. doi: 10.1111/ipd.12566. Epub 2019 Aug 13.
- Individual participant dataSharing planned: No. Data includes personel data of the participants.
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Dimensional Changes
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 digital intraoral scanner and Alginate Impression in people with Dental Impressions, run by Uşak University at 1 site in Turkey (Türkiye).
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 4 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: finished, as of the sponsor's last update on 2 May 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 Turkey (Türkiye). 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?
Modified Children Perception test (time frame: one year). 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 NCT06948617, 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 May 2025.