OrthodonticsNCT06380790
Effect of Laser-aided Csf on the Rate of Leveling and Alignment of Mandibular Anterior Crowding
A study testing Laser-aided csf in people with Orthodontics, run by Cairo University at 1 site in Egypt.
Trial summary
To test the effect of laser-aided circumferential supracrestal fiberotomy on the rate of leveling and alignment Read more about this study
- Who is it for?
- Ages 18 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Orthodontics
- What is being tested?
- Laser-aided csf
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2023to Oct 2024
- 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 18 to 25 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients indicated for orthodontic treatment 18-25 years
- full permanent dentition (not necessarily third molars)
- mandibular anterior crowding
- no visible anomaly of enamel
- good oral hygiene
Who cannot join
- patients with mandibular anterior teeth with advanced caries, prosthetic restorations or dental anomalies
- patients with dentofacial deformities or medical problems
- patients indicated for extractions as a part of orthodontic treatment
- patients with severe mandibular gingival inflammation/periodontitis
- pregnant female patients
- patients with previous orthodontic treatment
Show all 9Show fewer
- patients with previous mandibular extractions except third molars
- patients taking medications that could alter orthodontic treatment
- patients with clefts,syndromes, systemic diseases
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of dentistry cairo university
Cairo
Cairo University, 0223638755, ortho@dentistry.cu.edu.eg
About this study
Official title: Effect of Laser-aided Circumferential Supracrestal Fiberotomy on the Rate of Leveling and Alignment of Mandibular Anterior Crowding: A Randomized Controlled Clinical Trial
To test the effect of laser-aided circumferential supracrestal fiberotomy on the rate of leveling and alignment
- Conditions
- Orthodontics
- Being tested
- Laser-aided csf, placebo laser-aided csf
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser-aided csfProcedure or surgery
Laser-aided csf before leveling and alignment
placebo laser-aided csfOther
placebo laser-aided csf before leveling and alignment
| Study group | Role | What they receive |
|---|---|---|
| Control | Other | Placebo laser-aided csf Receives: Other: placebo laser-aided csf |
| Intervention | Other | Laser-aided csf before leveling and alignment Receives: Procedure: Laser-aided csf |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of tooth movement
Rate of leveling and alignment of mandibular incisors
Measured: 4 months
Secondary outcomes (2)
Pain level
Visual Analogue Scale
Measured: 1 week
Periodontal health
Gingival index
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 posted24 Apr 2024
- Study start1 May 2023
- Primary completionMay 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Khaled Mohamed Hamed Abdelkader, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06380790
- Sponsor's protocol ID
- 8423
- Status last verified
- Apr 2024
- First submitted
- 24 Mar 2024
- Last updated
- 24 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Laser-aided Circumferential Supracrestal Fiberotomy on the Rate of Leveling and Alignment of Mandibular Anterior Crowding: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06380790
- Acronym / sponsor ID
- 8423
- Conditions
- Orthodontics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- May 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 24 Apr 2024 (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.
To test the effect of laser-aided circumferential supracrestal fiberotomy on the rate of leveling and alignment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Other: placebo laser-aided csfPlacebo laser-aided csf |
| Intervention | Other | Procedure: Laser-aided csfLaser-aided csf before leveling and alignment |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients indicated for orthodontic treatment 18-25 years
- full permanent dentition (not necessarily third molars)
- mandibular anterior crowding
- no visible anomaly of enamel
- good oral hygiene
Key exclusion criteria (9 listed)
- patients with mandibular anterior teeth with advanced caries, prosthetic restorations or dental anomalies
- patients with dentofacial deformities or medical problems
- patients indicated for extractions as a part of orthodontic treatment
- patients with severe mandibular gingival inflammation/periodontitis
- pregnant female 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 |
|---|---|---|
| Laser-aided csfLaser-aided csf before leveling and alignment | Procedure or surgery | Intervention |
| placebo laser-aided csfplacebo laser-aided csf before leveling and alignment | Other | Control |
Primary outcome
Rate of tooth movement
Time frame: 4 months
Rate of leveling and alignment of mandibular incisors
2 secondary outcomes
Pain level
Time frame: 1 week
Periodontal health
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
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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 Laser-aided csf in people with 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 5 inclusion and 9 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 24 Apr 2024. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of tooth movement (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 24 Apr 2024.