Dental AnxietyNCT07002138
The Acceptability of Digital Impression Compared to Conventional Technique in Children
A study testing Digital Dental Impression and Conventional Dental Impression in people with Dental Anxiety and Gagging, run by Beirut Arab University at 1 site in Lebanon.
Trial summary
This randomized crossover clinical trial aims to evaluate the acceptability of digital intraoral impressions compared to conventional alginate impressions in children aged 6 to 11 years. The study will assess patient comfort, anxiety, time efficiency, and preference using validated tools. Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- Dental Anxiety, Gagging, Dental Impression Techniques
- What is being tested?
- Digital Dental Impression and Conventional Dental Impression
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteLebanon
- Study dates
- 1 Nov 2023to 17 May 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 6 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 6-11 years
- In need for the fabrication of fixed or removable appliance
- Having gagging problem based on the Classification of Gagging Problem scale starting from G1 to G5. (Saita et al., 2013) Where G1 is Normal Gagging: Normal gagging but not desensitized (controlled by the patient). The patient can withstand a full mouth examination with a dental mirror and a basic periodontal examination G2 is Mild gagging : Gagging when probe was used in a basic periodontal examination G3 is Moderate gagging: Gagging when examining molar teeth with a mirror G4 is Severe gagging: Gagging when examination of anterior teeth with a mirror G5 is Very severe gagging: Gagging at the moment when the dental mirror is inserted
Who cannot join
- Having a previous experience with any type of dental impressions.
- Having any systemic diseases or mental disorders.
Trial locations and contacts
1 site in 1 country.
Lebanon1 site
The Pediatric Dental clinics of the Faculty of Dentistry at Beirut Arab University
Beirut, 11072809
About this study
Official title: The Acceptability of Digital Impression Compared to Conventional Technique in Children - A Randomized Controlled Clinical Trial
This randomized crossover clinical trial aims to evaluate the acceptability of digital intraoral impressions compared to conventional alginate impressions in children aged 6 to 11 years. The study will assess patient comfort, anxiety, time efficiency, and preference using validated tools. A total of 40 children who require dental impressions for orthodontic or prosthetic treatment will be enrolled and randomly assigned to receive both impression techniques in alternating order, with a washout period of 14-21 days between sessions. Data collection includes Visual Analog Scale (VAS) scores for comfort and gag reflex, Venham's Clinical Anxiety Scale for anxiety assessment, and comparative questionnaires for both patients and parents. The study aims to determine whether digital impressions offer a more acceptable and less distressing alternative for pediatric patients in clinical dental settings.
Read the detailed description
This randomized crossover clinical trial aims to evaluate and compare the acceptability, comfort, time efficiency, and anxiety levels associated with digital intraoral impressions versus conventional alginate impressions in children aged 6 to 11 years. Dental impressions are essential in pediatric treatment planning, yet conventional alginate techniques are often poorly tolerated by children due to discomfort, taste, gagging, and procedural anxiety. Advances in digital dentistry, particularly intraoral scanners (IOS), provide a less invasive alternative with potential to enhance patient cooperation and improve the overall experience. Despite their growing use in adult patients, evidence regarding children's acceptance of intraoral scanning remains limited, particularly in the Middle East.
This study will be conducted at the Pediatric Dentistry Department of Beirut Arab University over a four-month period and will involve 40 pediatric patients who require dental impressions for fixed or removable appliances. A 1:1 randomization process will assign participants to one of two sequences: Group 1 will receive a digital impression first, followed by a conventional impression after a 14-21 day washout period; Group 2 will receive the procedures in reverse order. All procedures will be performed by a single calibrated operator.
Digital impressions will be made using the Medit i700 intraoral scanner, which allows 3D image acquisition without physical materials or trays. The scanning process includes drying the teeth and capturing occlusal, lingual, and buccal surfaces. Conventional impressions will be obtained using Hydrogum 5 alginate, involving tray selection, alginate mixing, and taking maxillary and mandibular impressions, followed by disinfection.
To assess acceptability and experience, several outcome measures will be recorded. Patient comfort and specific sensory responses will be measured using a Visual Analog Scale (VAS), where children will rate domains such as general feeling, breathing difficulty, taste or smell discomfort, thermal discomfort (heat/cold), gag reflex, and pain. Operator-assessed anxiety levels will be scored using the Venham's Clinical Anxiety Scale (VCAS), ranging from 0 (no anxiety) to 5 (severe anxiety). Total procedure time will be recorded using a digital stopwatch, beginning at tray or scanner insertion and ending at procedure completion. After both procedures, a structured comparative questionnaire will be administered to children, their parents, and the operator to assess perceived comfort, ease, duration, and preference.
Additionally, the operator's subjective perception of difficulty, applicability, and preference for each method will be documented. Intra-examiner reliability for digital scanning will be evaluated using repeated scans of 10 cases at a 48-hour interval, with agreement assessed via Cohen's Kappa statistic.
Statistical analysis will be conducted using SPSS version 26. Normality testing will guide the use of parametric or non-parametric tests (e.g., paired t-test or Wilcoxon signed-rank test), with a significance level set at α = 0.05. Descriptive statistics will be presented for baseline demographic data.
The study has been approved by the Ethics Committee of Beirut Arab University (Protocol ID: 2023-H-0139-D-M-0578). Informed consent will be obtained from parents or legal guardians before participation, and confidentiality will be strictly maintained. Participants will not incur costs or receive compensation.
By comparing these two impression methods in terms of comfort, anxiety, and feasibility, this study aims to generate original data relevant to pediatric dentistry and digital workflows. The findings may inform best practices and encourage the adoption of child-friendly technologies in clinical dental care.
- Being tested
- Digital Dental Impression, Conventional Dental Impression
- Keywords
- intraoral scanners, pediatric dentistry, gag reflex, alginate impressions, children preference, parents preference
- Medical subject headings
- Gagging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Dental ImpressionDevice
Also called Intraoral scan
Digital dental impressions were performed using the Medit i700 intraoral scanner (Medit, Seoul, South Korea). The scanner utilizes 3D-in-motion video technology with UV-C and LED light sources and adaptive anti-fogging. Scans were taken of both upper and lower arches following manufacturer-recommended protocols. Two tip sizes were used (normal and small), and scanning included occlusal, lingual, and buccal surfaces. Moisture control was maintained with cheek retractors and saliva ejectors. Impression time was recorded using a chronometer. This procedure was used to evaluate patient comfort, anxiety, and preference.
Conventional Dental ImpressionProcedure or surgery
Also called Alginate impression
Conventional impressions were taken using extra-fast setting flavored alginate (Hydrogum 5, Zhermack SpA, Italy) for both upper and lower arches. The impression material was manually mixed according to the manufacturer's instructions and applied using standard perforated plastic trays suitable for pediatric arches. Children were seated upright, and the impression sequence followed lower arch first, then upper arch. Comfort was evaluated using VAS scores and anxiety using the Venham Clinical Anxiety Scale (VCAS). The procedure was timed with a chronometer.
| Study group | Role | What they receive |
|---|---|---|
| Sequence A: Conventional First, then Digital | Experimental | Participants in this group receive a conventional alginate impression first (Hydrogum 5, Zhermack), followed by a digital intraoral scan (medit i700) (after a 14-21 day washout period). Receives: Device: Digital Dental Impression; Procedure: Conventional Dental Impression |
| Sequence B: Digital First, then Conventional | Experimental | Participants in this group receive a digital intraoral scan first (medit i700), followed by a conventional alginate impression (Hydrogum 5, Zhermack) after a 14-21 day washout period. Receives: Device: Digital Dental Impression; Procedure: Conventional Dental Impression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of patient comfort during digital and conventional methods
Child comfort level during each impression was recorded using the Visual Analogue Scale (VAS), a 6-point questionnaire 10 cm VAS where "10" represented maximum complaint whereas the value "0" meant no discomfort and better outcome. Scores were documented by the operator and analyzed across impression type, cooperation level, and gag reflex severity.
Measured: Assessed immediately following each impression procedure during the same clinical visit
Duration of digital versus conventional dental impressions
Time (in seconds) required to complete each impression was measured using a chronometer. Timing included preparation and execution phases. Durations for digital (Medit i700) and conventional (Hydrogum 5) impressions were compared across age groups, gag reflex severity, scanner tip size, and cooperation levels
Measured: Assessed immediately following each impression procedure during the same clinical visit
Secondary outcomes (3)
Comparison of child anxiety levels during digital and conventional impressions
Child anxiety during each impression was recorded using the Venham Clinical Anxiety Scale (VCAS), a 6-point behavioral assessment, where 0 represent no anxiety and 5 presents the maximum anxiety and worst outcome. Scores were documented by the operator and analyzed across impression type, cooperation level, and gag reflex severity.
Measured: Assessed immediately following each impression procedure during the same clinical visit.
Comparison of patient and caregiver preferences for digital versus conventional impressions
Children and their caregivers completed structured questionnaires after both impression procedures. Preferences were recorded for future use, perceived comfort, and overall experience with digital (Medit i700) versus conventional alginate (Hydrogum 5) impressions. Preferences were analyzed separately for impressions of the upper and lower arches.
Measured: Assessed immediately after digital procedure during the same clinical visit.
Comparison of operator perception of difficulty and applicability of digital versus conventional impressions
The operator completed a structured questionnaire after both impression procedures for each participant. The questionnaire assessed perceived level of difficulty, ease of application, and overall preference between the digital (Medit i700) and conventional (Hydrogum 5) methods. Results were analyzed to evaluate workflow challenges and usability from the clinician's perspective.
Measured: Assessed immediately after both impressions were completed for each participant during the same clinical session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2025
- Study start1 Nov 2023
- Primary completion17 May 2024
- Study completion17 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beirut Arab University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hind Tabbal, Beirut Arab University
- Investigators
- Associate Professor Ahmad Tarabaih, Associate Professor Ahmad, Study director, Beirut Arab University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07002138
- Sponsor's protocol ID
- 2023-H-0139-D-M-0578
- Status last verified
- May 2025
- First submitted
- 17 May 2025
- Last updated
- 3 Jun 2025
- 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 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Acceptability of Digital Impression Compared to Conventional Technique in Children - A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07002138
- Acronym / sponsor ID
- 2023-H-0139-D-M-0578
- Keywords
- intraoral scanners, pediatric dentistry, gag reflex, alginate impressions, children preference, parents preference
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Beirut Arab UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 17 May 2024 (actual)
- Study completion
- 17 May 2024 (actual)
- First posted
- 3 Jun 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.
This randomized crossover clinical trial aims to evaluate the acceptability of digital intraoral impressions compared to conventional alginate impressions in children aged 6 to 11 years. The study will assess patient comfort, anxiety, time efficiency, and preference using validated tools. A total of 40 children who require dental impressions for orthodontic or prosthetic treatment will be enrolled and randomly assigned to receive both impression techniques in alternating order, with a washout period of 14-21 days between sessions. Data collection includes Visual Analog Scale (VAS) scores for comfort and gag reflex, Venham's Clinical Anxiety Scale for anxiety assessment, and comparative questionnaires for both patients and parents. The study aims to determine whether digital impressions offer a more acceptable and less distressing alternative for pediatric patients in clinical dental settings.
Detailed description
This randomized crossover clinical trial aims to evaluate and compare the acceptability, comfort, time efficiency, and anxiety levels associated with digital intraoral impressions versus conventional alginate impressions in children aged 6 to 11 years. Dental impressions are essential in pediatric treatment planning, yet conventional alginate techniques are often poorly tolerated by children due to discomfort, taste, gagging, and procedural anxiety. Advances in digital dentistry, particularly intraoral scanners (IOS), provide a less invasive alternative with potential to enhance patient cooperation and improve the overall experience. Despite their growing use in adult patients, evidence regarding children's acceptance of intraoral scanning remains limited, particularly in the Middle East.
This study will be conducted at the Pediatric Dentistry Department of Beirut Arab University over a four-month period and will involve 40 pediatric patients who require dental impressions for fixed or removable appliances. A 1:1 randomization process will assign participants to one of two sequences: Group 1 will receive a digital impression first, followed by a conventional impression after a 14-21 day washout period; Group 2 will receive the procedures in reverse order. All procedures will be performed by a single calibrated operator.
Digital impressions will be made using the Medit i700 intraoral scanner, which allows 3D image acquisition without physical materials or trays. The scanning process includes drying the teeth and capturing occlusal, lingual, and buccal surfaces. Conventional impressions will be obtained using Hydrogum 5 alginate, involving tray selection, alginate mixing, and taking maxillary and mandibular impressions, followed by disinfection.
To assess acceptability and experience, several outcome measures will be recorded. Patient comfort and specific sensory responses will be measured using a Visual Analog Scale (VAS), where children will rate domains such as general feeling, breathing difficulty, taste or smell discomfort, thermal discomfort (heat/cold), gag reflex, and pain. Operator-assessed anxiety levels will be scored using the Venham's Clinical Anxiety Scale (VCAS), ranging from 0 (no anxiety) to 5 (severe anxiety). Total procedure time will be recorded using a digital stopwatch, beginning at tray or scanner insertion and ending at procedure completion. After both procedures, a structured comparative questionnaire will be administered to children, their parents, and the operator to assess perceived comfort, ease, duration, and preference.
Additionally, the operator's subjective perception of difficulty, applicability, and preference for each method will be documented. Intra-examiner reliability for digital scanning will be evaluated using repeated scans of 10 cases at a 48-hour interval, with agreement assessed via Cohen's Kappa statistic.
Statistical analysis will be conducted using SPSS version 26. Normality testing will guide the use of parametric or non-parametric tests (e.g., paired t-test or Wilcoxon signed-rank test), with a significance level set at α = 0.05. Descriptive statistics will be presented for baseline demographic data.
The study has been approved by the Ethics Committee of Beirut Arab University (Protocol ID: 2023-H-0139-D-M-0578). Informed consent will be obtained from parents or legal guardians before participation, and confidentiality will be strictly maintained. Participants will not incur costs or receive compensation.
By comparing these two impression methods in terms of comfort, anxiety, and feasibility, this study aims to generate original data relevant to pediatric dentistry and digital workflows. The findings may inform best practices and encourage the adoption of child-friendly technologies in clinical dental care.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence A: Conventional First, then Digital | Experimental | Device: Digital Dental Impression, Procedure: Conventional Dental ImpressionParticipants in this group receive a conventional alginate impression first (Hydrogum 5, Zhermack), followed by a digital intraoral scan (medit i700) (after a 14-21 day washout period). |
| Sequence B: Digital First, then Conventional | Experimental | Device: Digital Dental Impression, Procedure: Conventional Dental ImpressionParticipants in this group receive a digital intraoral scan first (medit i700), followed by a conventional alginate impression (Hydrogum 5, Zhermack) after a 14-21 day washout period. |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children aged 6-11 years
- In need for the fabrication of fixed or removable appliance
- Having gagging problem based on the Classification of Gagging Problem scale starting from G1 to G5. (Saita et al., 2013) Where G1 is Normal Gagging: Normal gagging but not desensitized (controlled by the patient). The patient can withstand a full mouth examination with a dental mirror and a basic periodontal examination G2 is Mild gagging : Gagging when probe was used in a basic periodontal examination G3 is Moderate gagging: Gagging when examining molar teeth with a mirror G4 is Severe gagging: Gagging when examination of anterior teeth with a mirror G5 is Very severe gagging: Gagging at the moment when the dental mirror is inserted
Key exclusion criteria (2 listed)
- Having a previous experience with any type of dental impressions.
- Having any systemic diseases or mental disorders.
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 Dental ImpressionAlso: Intraoral scanDigital dental impressions were performed using the Medit i700 intraoral scanner (Medit, Seoul, South Korea). The scanner utilizes 3D-in-motion video technology with UV-C and LED light sources and adaptive anti-fogging. Scans were taken of both upper and lower arches following manufacturer-recommended protocols. Two tip sizes were used (normal and small), and scanning included occlusal, lingual, and buccal surfaces. Moisture control was maintained with cheek retractors and saliva ejectors. Impression time was recorded using a chronometer. This procedure was used to evaluate patient comfort, anxiety, and preference. | Device | Sequence A: Conventional First, then Digital, Sequence B: Digital First, then Conventional |
| Conventional Dental ImpressionAlso: Alginate impressionConventional impressions were taken using extra-fast setting flavored alginate (Hydrogum 5, Zhermack SpA, Italy) for both upper and lower arches. The impression material was manually mixed according to the manufacturer's instructions and applied using standard perforated plastic trays suitable for pediatric arches. Children were seated upright, and the impression sequence followed lower arch first, then upper arch. Comfort was evaluated using VAS scores and anxiety using the Venham Clinical Anxiety Scale (VCAS). The procedure was timed with a chronometer. | Procedure or surgery | Sequence A: Conventional First, then Digital, Sequence B: Digital First, then Conventional |
Primary outcome
Comparison of patient comfort during digital and conventional methods
Time frame: Assessed immediately following each impression procedure during the same clinical visit
Child comfort level during each impression was recorded using the Visual Analogue Scale (VAS), a 6-point questionnaire 10 cm VAS where "10" represented maximum complaint whereas the value "0" meant no discomfort and better outcome. Scores were documented by the operator and analyzed across impression type, cooperation level, and gag reflex severity.
Duration of digital versus conventional dental impressions
Time frame: Assessed immediately following each impression procedure during the same clinical visit
Time (in seconds) required to complete each impression was measured using a chronometer. Timing included preparation and execution phases. Durations for digital (Medit i700) and conventional (Hydrogum 5) impressions were compared across age groups, gag reflex severity, scanner tip size, and cooperation levels
3 secondary outcomes
Comparison of child anxiety levels during digital and conventional impressions
Time frame: Assessed immediately following each impression procedure during the same clinical visit.
Comparison of patient and caregiver preferences for digital versus conventional impressions
Time frame: Assessed immediately after digital procedure during the same clinical visit.
Comparison of operator perception of difficulty and applicability of digital versus conventional impressions
Time frame: Assessed immediately after both impressions were completed for each participant during the same clinical session.
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 3 Jun 2025.
- Individual participant dataSharing planned: No
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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.
Associate Professor Ahmad Tarabaih, Associate Professor Ahmad study director
Beirut Arab University
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 Dental Impression and Conventional Dental Impression in people with Dental Anxiety and Gagging, run by Beirut Arab University at 1 site in Lebanon.
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: finished, as of the sponsor's last update on 3 Jun 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 Lebanon. 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?
Comparison of patient comfort during digital and conventional methods (time frame: Assessed immediately following each impression procedure during the same clinical visit). 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?
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 3 Jun 2025.