Dental Impression TechniqueNCT04220957
Digital Versus Conventional Impression Techniques in Children
A study testing Digital Impression Technique and Conventional Impression Technique in people with Dental Impression Technique, run by University of Florence at 1 site in Italy.
Trial summary
The impression is a necessary step for the orthodontic diagnosis. Digital impression has recently been introduced by means of intraoral optical scanners. To date, few studies have compared the conventional alginate impression with the digital impression with intraoral scanners. Read more about this study
- Who is it for?
- Ages 6 to 10 years
- Conditions the study is for
- Dental Impression Technique
- What is being tested?
- Digital Impression Technique and Conventional Impression Technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteItaly
- Study dates
- 11 Sep 2021to 30 Apr 2022
- 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 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Orthodontic patients between 6 and 10 years of age.
Who cannot join
- Noncompliant patients
- patients with syndromes or systemic diseases
- patients suffering from cleft lip and palate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Digital and Conventional Impression Techniques in Children: a Crossover Randomized Controlled Trial
The impression is a necessary step for the orthodontic diagnosis. Digital impression has recently been introduced by means of intraoral optical scanners. To date, few studies have compared the conventional alginate impression with the digital impression with intraoral scanners. These studies have shown that digital impression could have some advantages in terms of satisfaction and less discomfort for the pediatric patient. Only one study is randomized and has analyzed patients between 10 and 17 years of age. There are, therefore, no randomized trials for patients under 10 years of age.
The objective of the study is to compare the conventional alginate impression with the digital impression of both dental arches in orthodontic patients between 6 and 10 years of age with a randomized crossover design. In particular, the preference, comfort, impression taking time and other subjective aspects will be analyzed. This is a monocentric, controlled, superiority, randomized, crossover, open study.
Read more
Inclusion criteria:
- Orthodontic patients between 6 and 10 years of age.
Exclusion criteria:
- Noncompliant patients
- patients with syndromes or systemic diseases
- patients suffering from cleft lip and palate. The patient will be asked which of the 2 dental arch impression procedures they prefer. In addition, patients will be provided with a questionnaire including VAS (Visual Analogue Scale) for comfort, pain, gag reflex and breathing difficulty. The VAS will consist of scales from 0 to 10.
As for the calculation of the sample size, this has been done by considering a null hypothesis for a proportion of 50% in the preference between the two treatments and an alternative hypothesis of 80%. For alpha set at 0.05, a power of 80% and a dropout rate of 10%, 24 patients are required.
Descriptive statistics will be performed for all variables (frequency and percentage for qualitative variables and mean and standard deviation for quantitative variables). For the primary endpoint variable, impression procedure preference, the test will be performed for one proportion and the 95% confidence interval will be calculated using the Clopper-Pearson method.
With regard to the secondary endpoint variables, duration of the procedure, comfort, pain, gag reflex, breathing difficulty, the 2 procedures will be compared with the t-test for paired data.
An Intention-To-Treat analysis will be performed. In case more than 5 deviations from the protocol will occur, a sensitivity analysis will also be performed per protocol.
- Conditions
- Dental Impression Technique
- Being tested
- Digital Impression Technique, Conventional Impression Technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Impression TechniqueOther
Digital impressions of both arches will be taken by using an intraoral scanner (Trios 3, 3Shape, Denmark) by adhering to the scanning pattern recommended by the company for routine diagnosis and recording.
Conventional Impression TechniqueOther
Conventional Impression Technique of both arches will be taken with alginate (Orthoprint, Zhermack) on conventional stainless steel impression trays.
| Study group | Role | What they receive |
|---|---|---|
| Digital Impression Technique | Experimental | Impression with an intraoral scanner (TRIOS 3, 3Shape, Denmark) Receives: Other: Digital Impression Technique |
| Conventional Impression Technique | Active comparator | Conventional impression with alginate (Orthoprint, Zhermack) Receives: Other: Conventional Impression Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient's preference for either digital or conventional impression techniques
The patient will be asked "If you had to take another impression which one of the 2 impression techniques would you prefer?" The patient will mark on a sheet of paper which one of the 2 impression techniques he/she prefers.
Measured: 30 minutes
Secondary outcomes (5)
Comfort during impression taking
VAS (Visual Analogue Scale) from 0 to 10 with 0 corresponding to "very uncomfortable" and 10 corresponding to "maximum comfort"
Measured: 15 minutes
Pain during impression taking
VAS (Visual Analogue Scale) from 0 to 10 with 0 corresponding to "no pain" and 10 corresponding to "very painful"
Measured: 15 minutes
Gag reflex during impression taking
VAS (Visual Analogue Scale) from 0 to 10 with 0 corresponding to "no gag reflex" and 10 corresponding to "vomiting"
Measured: 15 minutes
Respiratory difficulty
VAS (Visual Analogue Scale) from 0 to 10 with 0 corresponding to "no respiratory difficulty" and 10 corresponding to "maximum respiratory difficulty"
Measured: 15 minutes
Duration of the impression procedure
Time recorded in minutes
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2020
- Study start11 Sep 2021
- Primary completion30 Apr 2022
- Study completion30 Apr 2022
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 Impression TechniqueStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florence
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lorenzo Franchi, University of Florence
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04220957
- Sponsor's protocol ID
- LF8
- Status last verified
- May 2022
- First submitted
- 3 Jan 2020
- Last updated
- 19 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bosoni C, Nieri M, Franceschi D, Souki BQ, Franchi L, Giuntini V. Comparison between digital and conventional impression techniques in children on preference, time and comfort: A crossover randomized controlled trial. Orthod Craniofac Res. 2023 Nov;26(4):585-590. doi: 10.1111/ocr.12648. Epub 2023 Mar 20.
PubMed 36891891
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Digital and Conventional Impression Techniques in Children: a Crossover Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04220957
- Acronym / sponsor ID
- LF8
- Conditions
- Dental Impression Technique
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of FlorenceUniversity, hospital or other
- Study start
- 11 Sep 2021 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 7 Jan 2020 (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 impression is a necessary step for the orthodontic diagnosis. Digital impression has recently been introduced by means of intraoral optical scanners. To date, few studies have compared the conventional alginate impression with the digital impression with intraoral scanners. These studies have shown that digital impression could have some advantages in terms of satisfaction and less discomfort for the pediatric patient. Only one study is randomized and has analyzed patients between 10 and 17 years of age. There are, therefore, no randomized trials for patients under 10 years of age.
The objective of the study is to compare the conventional alginate impression with the digital impression of both dental arches in orthodontic patients between 6 and 10 years of age with a randomized crossover design. In particular, the preference, comfort, impression taking time and other subjective aspects will be analyzed. This is a monocentric, controlled, superiority, randomized, crossover, open study.
Inclusion criteria:
- Orthodontic patients between 6 and 10 years of age.
Exclusion criteria:
- Noncompliant patients
- patients with syndromes or systemic diseases
- patients suffering from cleft lip and palate. The patient will be asked which of the 2 dental arch impression procedures they prefer. In addition, patients will be provided with a questionnaire including VAS (Visual Analogue Scale) for comfort, pain, gag reflex and breathing difficulty. The VAS will consist of scales from 0 to 10.
As for the calculation of the sample size, this has been done by considering a null hypothesis for a proportion of 50% in the preference between the two treatments and an alternative hypothesis of 80%. For alpha set at 0.05, a power of 80% and a dropout rate of 10%, 24 patients are required.
Descriptive statistics will be performed for all variables (frequency and percentage for qualitative variables and mean and standard deviation for quantitative variables). For the primary endpoint variable, impression procedure preference, the test will be performed for one proportion and the 95% confidence interval will be calculated using the Clopper-Pearson method.
With regard to the secondary endpoint variables, duration of the procedure, comfort, pain, gag reflex, breathing difficulty, the 2 procedures will be compared with the t-test for paired data.
An Intention-To-Treat analysis will be performed. In case more than 5 deviations from the protocol will occur, a sensitivity analysis will also be performed per protocol.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digital Impression Technique | Experimental | Other: Digital Impression TechniqueImpression with an intraoral scanner (TRIOS 3, 3Shape, Denmark) |
| Conventional Impression Technique | Active comparator | Other: Conventional Impression TechniqueConventional impression with alginate (Orthoprint, Zhermack) |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Orthodontic patients between 6 and 10 years of age.
Key exclusion criteria (3 listed)
- Noncompliant patients
- patients with syndromes or systemic diseases
- patients suffering from cleft lip and palate.
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 Impression TechniqueDigital impressions of both arches will be taken by using an intraoral scanner (Trios 3, 3Shape, Denmark) by adhering to the scanning pattern recommended by the company for routine diagnosis and recording. | Other | Digital Impression Technique |
| Conventional Impression TechniqueConventional Impression Technique of both arches will be taken with alginate (Orthoprint, Zhermack) on conventional stainless steel impression trays. | Other | Conventional Impression Technique |
Primary outcome
Patient's preference for either digital or conventional impression techniques
Time frame: 30 minutes
The patient will be asked "If you had to take another impression which one of the 2 impression techniques would you prefer?" The patient will mark on a sheet of paper which one of the 2 impression techniques he/she prefers.
5 secondary outcomes
Comfort during impression taking
Time frame: 15 minutes
Pain during impression taking
Time frame: 15 minutes
Gag reflex during impression taking
Time frame: 15 minutes
Respiratory difficulty
Time frame: 15 minutes
Duration of the impression procedure
Time frame: 15 minutes
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 19 May 2022.
- Derived from this study: PubMed 36891891Bosoni C, Nieri M, Franceschi D, Souki BQ, Franchi L, Giuntini V. Comparison between digital and conventional impression techniques in children on preference, time and comfort: A crossover randomized controlled trial. Orthod Craniofac Res. 2023 Nov;26(4):585-590. doi: 10.1111/ocr.12648. Epub 2023 Mar 20.
- Individual participant dataSharing planned: Undecided
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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.
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 Impression Technique and Conventional Impression Technique in people with Dental Impression Technique, run by University of Florence at 1 site in Italy.
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 1 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 19 May 2022. 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 Italy. 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?
Patient's preference for either digital or conventional impression techniques (time frame: 30 minutes). 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 NCT04220957, 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 19 May 2022.