Class II MalocclusionNCT06024382
The Effect of Low-level Laser Therapy on Functional Treatment of Skeletal Class II Patients
A study testing twin block and twin block combined with low level laser in people with Class II Malocclusion, run by Mansoura University at 1 site in Egypt.
Trial summary
this is a controlled clinical trial with 2 groups of patients of class II skeletal discrepancy due to mandibular retrusion one group is treated with twin block functional appliance and the other with twin block combined with low level laser therapy ,the study aims to detect the effect of low level laser on the… Read more about this study
- Who is it for?
- Ages 9 to 14 years
- Conditions the study is for
- Class II Malocclusion
- What is being tested?
- twin block and twin block combined with low level laser
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 26 Oct 2022to 28 Feb 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 9 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age (early permanent dentition)
- Cervical maturation stage CS 3-4
- Skeletal class II due to mandibular retrusion.
- Overjet more than 4mm.
Who cannot join
- Cleft lip or palate.
- Systemic diseases.
- Previous orthodontic treatment or abnormal habits.
- Congenital craniofacial deformity.
- poor oral hygiene
Trial locations and contacts
1 site in 1 country.
About this study
this is a controlled clinical trial with 2 groups of patients of class II skeletal discrepancy due to mandibular retrusion one group is treated with twin block functional appliance and the other with twin block combined with low level laser therapy ,the study aims to detect the effect of low level laser on the skeletal outcomes , dentoalveolar outcomes, rate of correction and pain during treatment
- Conditions
- Class II Malocclusion
- Being tested
- twin block, twin block combined with low level laser
- Keywords
- twin block , functional appliance , low level laser , photobiomodulation
- Medical subject headings
- Overbite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
twin blockOther
2 parallel groups one is treated with twin block and the other is treated with twin block combined with low level laser therapy
twin block combined with low level laserOther
2 parallel groups one is treated with twin block and the other is treated with twin block combined with low level laser therapy
| Study group | Role | What they receive |
|---|---|---|
| twin block | Experimental | group treated with twin block only Receives: Other: twin block |
| twin block combined with low level laser | Experimental | group treated with twin block combined with low level laser therapy Receives: Other: twin block combined with low level laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
treatment time
comparison of treatment between the 2 different groups
Measured: 8 months
Secondary outcomes (3)
cephalometric measurements
digital tracing of pre and post treatment cephalograms of both groups and comparison of linear and angular measurements
Measured: 8 months
study cast analysis
cast analysis of both groups measuring arch perimeter , intercanine wisth and intermolar width
Measured: 8 months
the short form McGill pain questionnaire
comparison of questionnaire results between the 2 groups
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2023
- Study start26 Oct 2022
- Primary completion30 Dec 2023
- Study completion28 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Class II MalocclusionStudies 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nada Gaballah, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06024382
- Sponsor's protocol ID
- dentist.1995
- Status last verified
- Mar 2024
- First submitted
- 23 Aug 2023
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Low-level Laser Therapy on Functional Treatment of Skeletal Class II Patients
- ClinicalTrials.gov ID
- NCT06024382
- Acronym / sponsor ID
- dentist.1995
- Conditions
- Class II Malocclusion
- Keywords
- twin block , functional appliance , low level laser , photobiomodulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 26 Oct 2022 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 6 Sep 2023 (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.
this is a controlled clinical trial with 2 groups of patients of class II skeletal discrepancy due to mandibular retrusion one group is treated with twin block functional appliance and the other with twin block combined with low level laser therapy ,the study aims to detect the effect of low level laser on the skeletal outcomes , dentoalveolar outcomes, rate of correction and pain during treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| twin block | Experimental | Other: twin blockgroup treated with twin block only |
| twin block combined with low level laser | Experimental | Other: twin block combined with low level lasergroup treated with twin block combined with low level laser therapy |
Who may qualify
- Ages
- 9 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age (early permanent dentition)
- Cervical maturation stage CS 3-4
- Skeletal class II due to mandibular retrusion.
- Overjet more than 4mm.
Key exclusion criteria (5 listed)
- Cleft lip or palate.
- Systemic diseases.
- Previous orthodontic treatment or abnormal habits.
- Congenital craniofacial deformity.
- poor 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 |
|---|---|---|
| twin block2 parallel groups one is treated with twin block and the other is treated with twin block combined with low level laser therapy | Other | twin block |
| twin block combined with low level laser2 parallel groups one is treated with twin block and the other is treated with twin block combined with low level laser therapy | Other | twin block combined with low level laser |
Primary outcome
treatment time
Time frame: 8 months
comparison of treatment between the 2 different groups
3 secondary outcomes
cephalometric measurements
Time frame: 8 months
study cast analysis
Time frame: 8 months
the short form McGill pain questionnaire
Time frame: 1 month
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 13 Mar 2024.
- Individual participant dataSharing planned: No
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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?
A study testing twin block and twin block combined with low level laser in people with Class II Malocclusion, 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 4 inclusion and 5 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 13 Mar 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?
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?
treatment time (time frame: 8 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 13 Mar 2024.