The Acceptability of Digital Impression Compared to Conventional Technique in Children (NCT07002138) | Clinical Trial Compass
CompletedNot Applicable
The Acceptability of Digital Impression Compared to Conventional Technique in Children
Lebanon40 participantsStarted 2023-11-01
Plain-language 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. 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.
Who can participate
Age range
6 Years – 11 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* Having a previous experience with any type of dental impressions.
* Having any systemic diseases or mental disorders.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Comparison of patient comfort during digital and conventional methods
Timeframe: Assessed immediately following each impression procedure during the same clinical visit
2
Duration of digital versus conventional dental impressions
Timeframe: Assessed immediately following each impression procedure during the same clinical visit