Dental Impression, Pediatric Dentistry, SatisfactionDigitalNCT06422611
Comparing Dental Impression Methods for Children
An observational study of Dental Impression, Pediatric Dentistry, Satisfaction, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
The precision of dental restorations and the production of dental models has improved due to the acceleration of technical advancement and the introduction of computer-aided manufacturing. Read more about this study
- Who is it for?
- Ages 7 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Impression, Pediatric Dentistry, Satisfaction
- What is being tested?
- Impression methods
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Apr 2023to 20 Aug 2023
- Phase
- Observational
- 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 7 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Patients who needed routine diagnostic records were included in our study.
Who may be able to join
- not to have a history of digital or conventional impression taking
- not to have temporomandibular joint and periodontal discomfort
- not to be using psychiatric or neuropathic drugs
Who cannot join
- history of digital or conventional impression taking
- TMJ disorder
- Using any kind of drug that interferes pain perception
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Traditional and Digital Impression Methods for Pediatric Patients in Terms of Satisfaction
The precision of dental restorations and the production of dental models has improved due to the acceleration of technical advancement and the introduction of computer-aided manufacturing.
The study's objective is to compare the conventional imprint approach with a digital one in order to compare patients' comfort levels, preferences, and treatment times among pediatric patients.
Read the detailed description
In this study, 60 volunteers without any prior exposure to traditional or digital impressions took part. Using a C-type impression medium, conventional impressions of the maxillary and mandibular dental arches were taken. Digital impressions are taken using an intra-oral scanner at the same appointment. Following the impressions, a standardized questionnaire was used to assess the individuals' attitudes, preferences, and perceptions of the impression procedures. The Wong-Baker Pain Rating Scale was used to assess the perceived source of stress and Frankl Behavioural Scale was used for assessing behaviour. After taking the impression, the processing phases of the impression techniques (working time, etc.), and parental satisfaction were noted.
- Being tested
- Impression methods
- Medical subject headings
- Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Impression methodsDevice
Both digital and conventional impressions were taken from same patients
| Study group | Role | What they receive |
|---|---|---|
| Digital | Impression was taken with intraoral scanners Receives: Device: Impression methods | |
| Conventional | Impression was taken with silicone impression material Receives: Device: Impression methods |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing patient preference and treatment comfort
Parental satisfaction was measured with a structured questionnaire.The Wong-Baker Pain Rating Scale was used to assess the perceived source of stress and Frankl Behavioural Scale was used for assessing behaviour. A survey was designed to test 3 areas of patient satisfaction regarding the impression experience: comfort, time, and novelty. The survey consisted of 7 statements with a 100-mm visual analog scale (VAS) below each statement anchored with "agree" and "disagree." The survey also included questions to determine whether the patient had previous experience with impressions.
Measured: March 2023-June 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2024
- Study start20 Apr 2023
- Primary completion30 May 2023
- Study completion20 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Impression, Pediatric Dentistry, SatisfactionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilsah Cogulu, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06422611
- Sponsor's protocol ID
- Ege U. Ethical Com. 23-4.1/5
- Acronym
- Digital
- Status last verified
- Apr 2023
- First submitted
- 16 Feb 2024
- Last updated
- 21 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Traditional and Digital Impression Methods for Pediatric Patients in Terms of Satisfaction
- ClinicalTrials.gov ID
- NCT06422611
- Acronym / sponsor ID
- Digital / Ege U. Ethical Com. 23-4.1/5
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 20 Apr 2023 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 20 Aug 2023 (actual)
- First posted
- 21 May 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.
The precision of dental restorations and the production of dental models has improved due to the acceleration of technical advancement and the introduction of computer-aided manufacturing.
The study's objective is to compare the conventional imprint approach with a digital one in order to compare patients' comfort levels, preferences, and treatment times among pediatric patients.
Detailed description
In this study, 60 volunteers without any prior exposure to traditional or digital impressions took part. Using a C-type impression medium, conventional impressions of the maxillary and mandibular dental arches were taken. Digital impressions are taken using an intra-oral scanner at the same appointment. Following the impressions, a standardized questionnaire was used to assess the individuals' attitudes, preferences, and perceptions of the impression procedures. The Wong-Baker Pain Rating Scale was used to assess the perceived source of stress and Frankl Behavioural Scale was used for assessing behaviour. After taking the impression, the processing phases of the impression techniques (working time, etc.), and parental satisfaction were noted.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digital | – | Device: Impression methodsImpression was taken with intraoral scanners |
| Conventional | – | Device: Impression methodsImpression was taken with silicone impression material |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Patients who needed routine diagnostic records were included in our study.
Key inclusion criteria (3 listed)
- not to have a history of digital or conventional impression taking
- not to have temporomandibular joint and periodontal discomfort
- not to be using psychiatric or neuropathic drugs
Key exclusion criteria (3 listed)
- history of digital or conventional impression taking
- TMJ disorder
- Using any kind of drug that interferes pain perception
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 |
|---|---|---|
| Impression methodsBoth digital and conventional impressions were taken from same patients | Device | Conventional, Digital |
Primary outcome
Assessing patient preference and treatment comfort
Time frame: March 2023-June 2023
Parental satisfaction was measured with a structured questionnaire.The Wong-Baker Pain Rating Scale was used to assess the perceived source of stress and Frankl Behavioural Scale was used for assessing behaviour. A survey was designed to test 3 areas of patient satisfaction regarding the impression experience: comfort, time, and novelty. The survey consisted of 7 statements with a 100-mm visual analog scale (VAS) below each statement anchored with "agree" and "disagree." The survey also included questions to determine whether the patient had previous experience with impressions.
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 21 May 2024.
- Individual participant dataSharing planned: No
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?
An observational study of Dental Impression, Pediatric Dentistry, Satisfaction, run by Ege 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 3 inclusion and 3 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 21 May 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 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?
Assessing patient preference and treatment comfort (time frame: March 2023-June 2023). 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 21 May 2024.