Amount of Labial Bone ThicknessNCT07320352
Assessment of Changes in Labial Bone Thickness and Root Surface After Enmasse Retraction With and Without Hard Laser Assistance
A study testing Hard laser therapy biolase device and Enmass retraction without hard laser in people with Amount of Labial Bone Thickness and Amount of Root Resorption, run by Faculty of Dental Medicine for Girls at 1 site in Egypt.
Trial summary
Assessment of Changes in Labial Bone Thickness and Root Surface After Enmasse Retraction With and Without Hard Laser Assistance:Comparative Randomized Cllinical Trial Read more about this study
- Who is it for?
- Ages 16 to 23 years, women only
- Conditions the study is for
- Amount of Labial Bone Thickness, Amount of Root Resorption
- What is being tested?
- Hard laser therapy biolase device and Enmass retraction without hard laser
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Feb 2024to 20 Oct 2025
- 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 16 to 23 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- class 2 division1 malocclusion
- Dentoalveolar bimaxillary protrusion
- Extraction of maxillary 1st premolars
- No evidence of root resorption
- cooperative patient
Who cannot join
- un cooperative patient
- Bleeding disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Changes in Labial Bone Thickness and Root Surface After Enmasse Retraction With and Without Hard Laser Assistance:Comparative Randomized Cllinical Trial
Assessment of Changes in Labial Bone Thickness and Root Surface After Enmasse Retraction With and Without Hard Laser Assistance:Comparative Randomized Cllinical Trial
- Being tested
- Hard laser therapy biolase device, Enmass retraction without hard laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hard laser therapy biolase deviceProcedure or surgery
Enmass retraction after hard laser therapy with biolase machine
Enmass retraction without hard laserDevice
with long hook and memory power chain
| Study group | Role | What they receive |
|---|---|---|
| Enmass retraction with hard laser therapy and effect on labial bone thickness and root resorption | Experimental | Not described Receives: Procedure: Hard laser therapy biolase device |
| Enmass retraction without hard laser therapy and effect on labial bone thickness and root resorption | Experimental | Not described Receives: Device: Enmass retraction without hard laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluation of labial bone thickness with and without hard laser.
Measured: 1year
evaluation of root surface changes with and without hard laser.
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start28 Feb 2024
- Primary completion20 Sep 2025
- Study completion20 Oct 2025
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 Amount of Labial Bone ThicknessStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculty of Dental Medicine for Girls
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Salma Toubar, Faculty of Dental Medicine for Girls
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07320352
- Sponsor's protocol ID
- ORTHO-108-2-K
- Status last verified
- Dec 2025
- First submitted
- 23 Nov 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Almagrami I, Albarakani AY, Almashraqi AA, Alhammadi MS, Al-Warafi LA, Almaqrami M, Qiao Y. Volumetric and tridimensional root resorption and alveolar bone changes in Class II malocclusion extraction protocol treated with clear aligners and fixed orthodontic appliances: A comparative study. Am J Orthod Dentofacial Orthop. 2025 May;167(5):539-549. doi: 10.1016/j.ajodo.2024.11.012. Epub 2025 Jan 9.
PubMed 39797866
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Changes in Labial Bone Thickness and Root Surface After Enmasse Retraction With and Without Hard Laser Assistance:Comparative Randomized Cllinical Trial
- ClinicalTrials.gov ID
- NCT07320352
- Acronym / sponsor ID
- ORTHO-108-2-K
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Faculty of Dental Medicine for GirlsOther government
- Study start
- 28 Feb 2024 (actual)
- Primary completion
- 20 Sep 2025 (actual)
- Study completion
- 20 Oct 2025 (actual)
- First posted
- 6 Jan 2026 (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.
Assessment of Changes in Labial Bone Thickness and Root Surface After Enmasse Retraction With and Without Hard Laser Assistance:Comparative Randomized Cllinical Trial
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enmass retraction with hard laser therapy and effect on labial bone thickness and root resorption | Experimental | Procedure: Hard laser therapy biolase device |
| Enmass retraction without hard laser therapy and effect on labial bone thickness and root resorption | Experimental | Device: Enmass retraction without hard laser |
Who may qualify
- Ages
- 16 to 23 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- class 2 division1 malocclusion
- Dentoalveolar bimaxillary protrusion
- Extraction of maxillary 1st premolars
- No evidence of root resorption
- cooperative patient
Key exclusion criteria (2 listed)
- un cooperative patient
- Bleeding disorders
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 |
|---|---|---|
| Hard laser therapy biolase deviceEnmass retraction after hard laser therapy with biolase machine | Procedure or surgery | Enmass retraction with hard laser therapy and effect on labial bone thickness and root resorption |
| Enmass retraction without hard laserwith long hook and memory power chain | Device | Enmass retraction without hard laser therapy and effect on labial bone thickness and root resorption |
Primary outcome
evaluation of labial bone thickness with and without hard laser.
Time frame: 1year
evaluation of root surface changes with and without hard laser.
Time frame: 1year
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 6 Jan 2026.
- Results publication: PubMed 39797866Almagrami I, Albarakani AY, Almashraqi AA, Alhammadi MS, Al-Warafi LA, Almaqrami M, Qiao Y. Volumetric and tridimensional root resorption and alveolar bone changes in Class II malocclusion extraction protocol treated with clear aligners and fixed orthodontic appliances: A comparative study. Am J Orthod Dentofacial Orthop. 2025 May;167(5):539-549. doi: 10.1016/j.ajodo.2024.11.012. Epub 2025 Jan 9.
- Volumetric and tridimensional root resorption and alveolar bone changes in Class II malocclusion extraction protocolLink provided by the sponsor.
- Individual participant dataSharing planned: No
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 Hard laser therapy biolase device and Enmass retraction without hard laser in people with Amount of Labial Bone Thickness and Amount of Root Resorption, run by Faculty of Dental Medicine for Girls 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 2 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 6 Jan 2026. 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?
evaluation of labial bone thickness with and without hard laser. (time frame: 1year). The study lists 2 primary outcomes in all. 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 NCT07320352, 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 6 Jan 2026.