Class II Division 1 MalocclusionNCT05465473
Effect of Low-level Laser Therapy During Maxillary Molar Distalization Using a Skeletally Anchored Appliance
A study testing Distalization in people with Class II Division 1 Malocclusion, run by Al-Azhar University at 1 site in Egypt.
Trial summary
study will be directed to evaluate the effect of low-level laser therapy during maxillary molar distalization using a skeletally anchored appliance Read more about this study
- Who is it for?
- Ages 14 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Class II Division 1 Malocclusion
- What is being tested?
- Distalization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Dec 2021to 12 Dec 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 14 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 1- An age range from 14-17 years old. 2- All permanent teeth are present (except for third molars). 3- Bilateral dental Class II malocclusion. 4- Skeletal Class I or mild Class II relationship. 5- Normal or reduced vertical face height. 6- No posterior crowding or spaces.
Who cannot join
- Patients who required surgery to correct skeletal discrepancies.
- Patients with congenital dentoskeletal disorders.
- Missed or mutilated teeth in maxillary arch.
- Patients with poor oral hygiene and/or periodontally compromised patients.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Al Azhar university
Cairo
Ahmed T Ali, Ass. lecturer, 01008748904 ext. +20, ahmedAli.209@azhar.edu.eg
About this study
Official title: Effect of Low-level Laser Therapy During Maxillary Molar Distalization Using a Skeletally Anchored Appliance: A Prospective Clinical Study
study will be directed to evaluate the effect of low-level laser therapy during maxillary molar distalization using a skeletally anchored appliance
Read the detailed description
Effect of low-level laser therapy during maxillary molar distalization using a skeletally anchored appliance
- Conditions
- Class II Division 1 Malocclusion
- Being tested
- Distalization
- Medical subject headings
- Malocclusion, Angle Class II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DistalizationOther
Group I: will include 10 patients undergo distalization according to a standardized protocol. Group II: will include 10 patients undergo distalization assisted with low level laser therapy according to a standardized protocol.
| Study group | Role | What they receive |
|---|---|---|
| Group I | Active comparator | will include 10 patients undergo distalization according to a standardized protocol Receives: Other: Distalization |
| Group II | Active comparator | will include 10 patients undergo distalization assisted with low level laser therapy according to a standardized protocol Receives: Other: Distalization |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of molar distalization
rate of distalization of the maxillary first molars will be evaluated using direct clinical assessment and cast analysis according to standardized methods.
Measured: from start of treatment until study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2022
- Study start12 Dec 2021
- Primary completion12 Aug 2022 (estimated)
- Study completion12 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Class II Division 1 MalocclusionStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Talaat Hussein Ali, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05465473
- Sponsor's protocol ID
- 647/1760
- Status last verified
- Jul 2022
- First submitted
- 8 Jul 2022
- Last updated
- 19 Jul 2022
- Results posted
- No
- 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 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low-level Laser Therapy During Maxillary Molar Distalization Using a Skeletally Anchored Appliance: A Prospective Clinical Study
- ClinicalTrials.gov ID
- NCT05465473
- Acronym / sponsor ID
- 647/1760
- Conditions
- Class II Division 1 Malocclusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 12 Dec 2021 (actual)
- Primary completion
- 12 Aug 2022 (estimated)
- Study completion
- 12 Dec 2022 (estimated)
- First posted
- 19 Jul 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.
study will be directed to evaluate the effect of low-level laser therapy during maxillary molar distalization using a skeletally anchored appliance
Detailed description
Effect of low-level laser therapy during maxillary molar distalization using a skeletally anchored appliance
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | Active comparator | Other: Distalizationwill include 10 patients undergo distalization according to a standardized protocol |
| Group II | Active comparator | Other: Distalizationwill include 10 patients undergo distalization assisted with low level laser therapy according to a standardized protocol |
Who may qualify
- Ages
- 14 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 1- An age range from 14-17 years old. 2- All permanent teeth are present (except for third molars). 3- Bilateral dental Class II malocclusion. 4- Skeletal Class I or mild Class II relationship. 5- Normal or reduced vertical face height. 6- No posterior crowding or spaces.
Key exclusion criteria (4 listed)
- Patients who required surgery to correct skeletal discrepancies.
- Patients with congenital dentoskeletal disorders.
- Missed or mutilated teeth in maxillary arch.
- Patients with poor oral hygiene and/or periodontally compromised patients.
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 |
|---|---|---|
| DistalizationGroup I: will include 10 patients undergo distalization according to a standardized protocol. Group II: will include 10 patients undergo distalization assisted with low level laser therapy according to a standardized protocol. | Other | Group I, Group II |
Primary outcome
rate of molar distalization
Time frame: from start of treatment until study completion, an average of 1 year
rate of distalization of the maxillary first molars will be evaluated using direct clinical assessment and cast analysis according to standardized methods.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Distalization in people with Class II Division 1 Malocclusion, run by Al-Azhar 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 4 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: status not confirmed, as of the sponsor's last update on 19 Jul 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed T Hussein, doctoraa (01008748904, AhmedAli.209@azhar.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of molar distalization (time frame: from start of treatment until study completion, an average of 1 year). 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 19 Jul 2022.