Digital OrthodonticsNCT05389969
Efficiency Of Different Intraoral Scanning Techniques In Orthodontic Patients Before And After Brackets Positioning: A Cross Sectional Study
An observational study of Digital Orthodontics, run by Cairo University at 1 site in Egypt.
Trial summary
A Cross-sectional study, in which we compare the efficiency of different scanning techniques in orthodontic patients before and after brackets positioning. Scanning of the maxillary and mandibular dental arch will be performed for the same group of patients twice. Read more about this study
- Who is it for?
- Ages 15 to 20 years
- Conditions the study is for
- Digital Orthodontics
- What is being tested?
- digital arch scanning
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Feb 2022to 1 Apr 2022
- How long will I take part?
- 1 Day
- 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 15 to 20 years
- All sexes
- Child, Adult
Study population: Adolescent patients with Fully erupted permanent dentition from second molar to the contra lateral second molar in both jaws.
Who may be able to join
- Adolescent patients.
- Fully erupted permanent dentition from second molar to the contra lateral second molar in both jaws.
Who cannot join
- Severe degree of malocclusion that prevent full arch bracket positioning
- Dento-facial deformity such as cleft lip/ palate or cranio-facial syndrome.
- Severe Skeletal discrepancy in any of the three planes of space.
- TMD problem
- Limited mouth opening
- Presence of crowns or bridges.
Trial locations and contacts
1 site in 1 country.
About this study
A Cross-sectional study, in which we compare the efficiency of different scanning techniques in orthodontic patients before and after brackets positioning.
Scanning of the maxillary and mandibular dental arch will be performed for the same group of patients twice. The first time is before bracket positioning using two different scanners and the three different techniques. The second time is after brackets positioning using the same two different scanners and the same three different scanning techniques.
Then these scans will be compared to by superimposition techniques and linear measurement techniques.
Read the detailed description
In this study two scanners will be utilized Medit i500 and Trios 3. For each scanner three techniques will be used at two different interventions. One before brackets positioning and the other after bracket positioning. American orthodontics ROTH prescription, 0.022 slot metal brackets will be positioned using direct bonding technique.
Three different scanning techniques will be used: buccopalatal technique, S-shaped technique and palatobuccal technique. The buccopalatal technique (A) involves scanning the arch top side starting from the left second molar then run longitudinally to the contra-lateral one. Then go to the buccal side scan from this right side to the contra-lateral side and then palatal scan. Palatal scan done in two steps first was with counterclockwise movement along the palatal vault and then longitudinal movement in postro-anterior direction.
The S-shaped technique (B) involves scanning the arch starting from the palatal side of the left second molar then moving the scanner tip in alternating palatobuccal and buccopalatal S-shaped movement along the arch to the contra-lateral side. Then scanning the mid area of the palate by longitudinal movement in postro-anterior direction.
The palatobuccal technique (c) done by scanning the arch top side first starting from the left second molar runs longitudinally to the contralateral side. Then start palatal scanning by moving the scanner tip with circular movement in a clockwise direction across the palatal vault from the right-side second molar then along the palate to the contralateral second molar. Then the same circular scanning but in the counterclockwise direction to record the remaining part of the palate staring from the left second molar to the contralateral one. The buccal scan will follow starting from the right second molar then run longitudinally to the contralateral side.
- Conditions
- Digital Orthodontics
- Being tested
- digital arch scanning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
digital arch scanningOther
Scanning of the maxillary and mandibular dental arch will be performed for the same group of patients twice. The first time is before bracket positioning using two different scanners and the three different techniques. The second time is after brackets positioning using the same two different scanners and the same three different scanning techniques.
Then these scans will be compared to by superimposition techniques and linear measurement techniques.
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of repeatability between in-vivo and ex-vivo scans
Measured: 2 to 3 weeks
Secondary outcomes (2)
The effect of the type of the scanner on the scanning quality.
Measured: 2 to 3 weeks
The effect of the bracket presence on the scanning quality.
Measured: 2 to 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study start12 Feb 2022
- Primary completion1 Apr 2022
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Digital OrthodonticsStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 10 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Karam Salim, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05389969
- Sponsor's protocol ID
- 14422020488903
- Status last verified
- May 2022
- First submitted
- 20 May 2022
- Last updated
- 25 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency Of Different Intraoral Scanning Techniques In Orthodontic Patients Before And After Brackets Positioning: A Cross Sectional Study
- ClinicalTrials.gov ID
- NCT05389969
- Acronym / sponsor ID
- 14422020488903
- Conditions
- Digital Orthodontics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 12 Feb 2022 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 25 May 2022 (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.
A Cross-sectional study, in which we compare the efficiency of different scanning techniques in orthodontic patients before and after brackets positioning.
Scanning of the maxillary and mandibular dental arch will be performed for the same group of patients twice. The first time is before bracket positioning using two different scanners and the three different techniques. The second time is after brackets positioning using the same two different scanners and the same three different scanning techniques.
Then these scans will be compared to by superimposition techniques and linear measurement techniques.
Detailed description
In this study two scanners will be utilized Medit i500 and Trios 3. For each scanner three techniques will be used at two different interventions. One before brackets positioning and the other after bracket positioning. American orthodontics ROTH prescription, 0.022 slot metal brackets will be positioned using direct bonding technique.
Three different scanning techniques will be used: buccopalatal technique, S-shaped technique and palatobuccal technique. The buccopalatal technique (A) involves scanning the arch top side starting from the left second molar then run longitudinally to the contra-lateral one. Then go to the buccal side scan from this right side to the contra-lateral side and then palatal scan. Palatal scan done in two steps first was with counterclockwise movement along the palatal vault and then longitudinal movement in postro-anterior direction.
The S-shaped technique (B) involves scanning the arch starting from the palatal side of the left second molar then moving the scanner tip in alternating palatobuccal and buccopalatal S-shaped movement along the arch to the contra-lateral side. Then scanning the mid area of the palate by longitudinal movement in postro-anterior direction.
The palatobuccal technique (c) done by scanning the arch top side first starting from the left second molar runs longitudinally to the contralateral side. Then start palatal scanning by moving the scanner tip with circular movement in a clockwise direction across the palatal vault from the right-side second molar then along the palate to the contralateral second molar. Then the same circular scanning but in the counterclockwise direction to record the remaining part of the palate staring from the left second molar to the contralateral one. The buccal scan will follow starting from the right second molar then run longitudinally to the contralateral side.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 15 to 20 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Adolescent patients with Fully erupted permanent dentition from second molar to the contra lateral second molar in both jaws.
Key inclusion criteria (2 listed)
- Adolescent patients.
- Fully erupted permanent dentition from second molar to the contra lateral second molar in both jaws.
Key exclusion criteria (6 listed)
- Severe degree of malocclusion that prevent full arch bracket positioning
- Dento-facial deformity such as cleft lip/ palate or cranio-facial syndrome.
- Severe Skeletal discrepancy in any of the three planes of space.
- TMD problem
- Limited mouth opening
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 arch scanningScanning of the maxillary and mandibular dental arch will be performed for the same group of patients twice. The first time is before bracket positioning using two different scanners and the three different techniques. The second time is after brackets positioning using the same two different scanners and the same three different scanning techniques. Then these scans will be compared to by superimposition techniques and linear measurement techniques. | Other | – |
Primary outcome
Comparison of repeatability between in-vivo and ex-vivo scans
Time frame: 2 to 3 weeks
2 secondary outcomes
The effect of the type of the scanner on the scanning quality.
Time frame: 2 to 3 weeks
The effect of the bracket presence on the scanning quality.
Time frame: 2 to 3 weeks
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 25 May 2022.
- 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?
An observational study of Digital Orthodontics, run by Cairo University at 1 site in Egypt.
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 2 inclusion and 6 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 25 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 Egypt. 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 repeatability between in-vivo and ex-vivo scans (time frame: 2 to 3 weeks). 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 25 May 2022.