Anterior Functional ShiftWSLNCT06798870
White Spot Lesions Development in Mixed Dentition Patients
A study testing removable appliances in people with Anterior Functional Shift, run by Mansoura University at 1 site in Egypt.
Trial summary
36 patient will be divided into two equal groups. one for removable inclined plane while the other will be treated using clear aligner appliances. evaluation of the white spot lesion will be accumplished for all patients clinically before anr after completion of treatment. Read more about this study
- Who is it for?
- Ages 9 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Anterior Functional Shift
- What is being tested?
- removable appliances
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Jul 2024to 15 Mar 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 9 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients with the age range of 9 to 12 years with anterior crossbite will be selected for the study
Who cannot join
- periodontal diseases, bone resorption cleft lip and palate deformities, orofacial syndrome, hypoplastic enamel defects, and multiple restorations on the facial surfaces or unable to maintain good oral hygiene
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of White Spot Lesions Development During Management of Mixed Dentition Patients with Anterior Functional Shift
36 patient will be divided into two equal groups. one for removable inclined plane while the other will be treated using clear aligner appliances. evaluation of the white spot lesion will be accumplished for all patients clinically before anr after completion of treatment.
Read the detailed description
The sample size was calculated using G*Power (Version 3.1.9.4; Germany) and designed to have a power of 82% assuming type I statistical error of 5% and one-tailed statistical test based on Azeem and Hamid.13 The calculated sample was 15 patients in each group. The sample will be increased to include 36 patients: 18 patients per group for a 20% expected loss.
Patients with the age range of 9 to 12 years will be selected for the study. All patients and their parents will be informed of the procedures and will sign the informed consent. Patients who had periodontal diseases, bone resorption cleft lip and palate deformities, orofacial syndrome, hypoplastic enamel defects, and multiple restorations on the facial surfaces or unable to maintain good oral hygiene will be excluded from the study.
All patients will be randomly allocated into two groups according to the management protocol: inclined plane and clear aligner. The patients will be examined for any white spot lesion on the labial surface of the teeth in the upper and lower jaws clinically and using lateral and frontal intraoral photographs immediately before treatment and monthly along the treatment procedures. Each tooth will be evaluated, and the total lesions count will be recorded for each patient. All patients will be instructed to maintain good oral hygiene using fluoridated toothpaste daily.
Statistical analysis:
The incidence of the WSL in each tooth and the total lesions count will be calculated for each patient. These data will be collected and subjected to the appropriate statistical tests using the SPSS version 20.0 software for Windows (IBM, USA).
- Conditions
- Anterior Functional Shift
- Being tested
- removable appliances
- Keywords
- white spot lesion, mixed dentition patients, clear aligner, anterior functional shift
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
removable appliancesDevice
removable appliances; clear aligner and removable inclined plane, for correcting anterior crossbite vin mixed dentition patient
| Study group | Role | What they receive |
|---|---|---|
| Removable inclined plane group | Active comparator | removable appliance for correcting anterior crossbite Receives: Device: removable appliances |
| clear aligner | Active comparator | clear aligner appliance for correcting anterior crossbite Receives: Device: removable appliances |
What is being measured
The primary outcome is the main question the study is designed to answer.
development of white spot lesion
examination of the teeth clinically for detecting white spot lesion
Measured: 4 months
Secondary outcomes (1)
the highly incidence of white spot lesion in upper and lower teeth
counting the mostly affected teeth by white spot lesion
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start2 Jul 2024
- Primary completion30 Jan 2025 (estimated)
- Study completion15 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Functional ShiftStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- NEHAL F Albelasy, PhD, Principal investigator, Egypt, Mansoura university, faculty of Dentistry, orthodontic department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06798870
- Sponsor's protocol ID
- A0207024OR
- Other IDs
- A0207024OR
- Acronym
- WSL
- Status last verified
- Dec 2024
- First submitted
- 30 Dec 2024
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of White Spot Lesions Development During Management of Mixed Dentition Patients with Anterior Functional Shift
- ClinicalTrials.gov ID
- NCT06798870
- Acronym / sponsor ID
- WSL / A0207024OR
- Conditions
- Anterior Functional Shift
- Keywords
- white spot lesion, mixed dentition patients, clear aligner, anterior functional shift
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 2 Jul 2024 (actual)
- Primary completion
- 30 Jan 2025 (estimated)
- Study completion
- 15 Mar 2025 (estimated)
- First posted
- 29 Jan 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.
36 patient will be divided into two equal groups. one for removable inclined plane while the other will be treated using clear aligner appliances. evaluation of the white spot lesion will be accumplished for all patients clinically before anr after completion of treatment.
Detailed description
The sample size was calculated using G*Power (Version 3.1.9.4; Germany) and designed to have a power of 82% assuming type I statistical error of 5% and one-tailed statistical test based on Azeem and Hamid.13 The calculated sample was 15 patients in each group. The sample will be increased to include 36 patients: 18 patients per group for a 20% expected loss.
Patients with the age range of 9 to 12 years will be selected for the study. All patients and their parents will be informed of the procedures and will sign the informed consent. Patients who had periodontal diseases, bone resorption cleft lip and palate deformities, orofacial syndrome, hypoplastic enamel defects, and multiple restorations on the facial surfaces or unable to maintain good oral hygiene will be excluded from the study.
All patients will be randomly allocated into two groups according to the management protocol: inclined plane and clear aligner. The patients will be examined for any white spot lesion on the labial surface of the teeth in the upper and lower jaws clinically and using lateral and frontal intraoral photographs immediately before treatment and monthly along the treatment procedures. Each tooth will be evaluated, and the total lesions count will be recorded for each patient. All patients will be instructed to maintain good oral hygiene using fluoridated toothpaste daily.
Statistical analysis:
The incidence of the WSL in each tooth and the total lesions count will be calculated for each patient. These data will be collected and subjected to the appropriate statistical tests using the SPSS version 20.0 software for Windows (IBM, USA).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Removable inclined plane group | Active comparator | Device: removable appliancesremovable appliance for correcting anterior crossbite |
| clear aligner | Active comparator | Device: removable appliancesclear aligner appliance for correcting anterior crossbite |
Who may qualify
- Ages
- 9 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Patients with the age range of 9 to 12 years with anterior crossbite will be selected for the study
Key exclusion criteria (1 listed)
- periodontal diseases, bone resorption cleft lip and palate deformities, orofacial syndrome, hypoplastic enamel defects, and multiple restorations on the facial surfaces or unable to maintain good oral hygiene
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 |
|---|---|---|
| removable appliancesremovable appliances; clear aligner and removable inclined plane, for correcting anterior crossbite vin mixed dentition patient | Device | Removable inclined plane group, clear aligner |
Primary outcome
development of white spot lesion
Time frame: 4 months
examination of the teeth clinically for detecting white spot lesion
1 secondary outcome
the highly incidence of white spot lesion in upper and lower teeth
Time frame: 4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
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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.
NEHAL F Albelasy, PhD principal investigator
Egypt, Mansoura university, faculty of Dentistry, orthodontic department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing removable appliances in people with Anterior Functional Shift, run by Mansoura 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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 29 Jan 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 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?
This study is still under way. Results are not available in the source record yet.
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?
development of white spot lesion (time frame: 4 months). 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 29 Jan 2025.