Maxillary First Molar DistalizationNCT06507319
Comparative Evaluation Of Two Bone-Anchored Maxillary Molar Distalization Appliances: Direct Versus Indirect Anchorage
A study testing Direct bone anchored pull distal slider and Indirect bone anchored dual force distalizer. in people with Maxillary First Molar Distalization, run by Mansoura University at 1 site in Egypt.
Trial summary
Aim of study: this study will be conducted for Comparative Evaluation Of Two Bone-Anchored Maxillary Molar Distalization Appliances: Direct Versus Indirect Anchorage. Material and methods: The study will consist of two groups, each group has 10 Patients. Read more about this study
- Who is it for?
- Ages 12 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Maxillary First Molar Distalization
- What is being tested?
- Direct bone anchored pull distal slider and Indirect bone anchored dual force distalizer.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 8 Jun 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 12 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Dental class II.
- No or mild to moderate maxillary teeth crowding.
- Erupted or partially erupted maxillary second molars.
- No previous orthodontic therapy.
- Absence or minimum crowding in the mandibular arch.
- Good oral hygiene.
Who cannot join
- Dental class I, III
- severe maxillary teeth crowding.
- Extracted or badly decayed maxillary first molars.
- Previous orthodontic therapy.
- Severe crowding in the mandibular arch.
- Bad oral hygiene.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry
Al Mansurah
Marwa S Shamaa, professor, marwashamaa011@gmail.com
Mohammad Hasan, Phd, mohammadhasan@mans.edu.eg
About this study
Aim of study: this study will be conducted for Comparative Evaluation Of Two Bone-Anchored Maxillary Molar Distalization Appliances: Direct Versus Indirect Anchorage.
Material and methods: The study will consist of two groups, each group has 10 Patients. The patients will be selected from the outpatient clinic of the orthodontic department at Mansoura University.
Patients will be divided into 2 groups, group 1 will be treated by direct bone anchored pull distal slider, and group 2 by indirect bone anchored dual force distalizer.
Read the detailed description
Aim of study:
this study will be conducted for Comparative Evaluation Of Two Bone-Anchored Maxillary Molar Distalization Appliances: Direct Versus Indirect Anchorage.
Participant and eligibility criteria:
The study will consist of two groups, each group has 10 Patients. The patients will be selected from the outpatient clinic of the orthodontic department at Mansoura University. pretreatment records will be taken including: intraoral and extraoral photographs, study models, panoramic radiographs, and lateral cephalometric radiographs.
Intervention:
written and informed consents will be taken from the patients.
Group 1:
- Two metal bands will be chosen and fitted on the maxillary first molars.
- Rubber base impression material will be taken with bands in place.
- Two metal bands will be placed in their relative positions in the impression and then poured up with stone.
- Send it to the LAB for appliance fabrication.
- At delivery day, the appliance will be cemented on the maxillary first molars by glass ionomer luting cement and two miniscrews will be placed in their positions.
- The appliance will be activated by closed coil spring, which apply 300g force. Patients will be monitored every 3 weeks.
Group 2:
- Four metal bands ( two for maxillary first premolars and two for maxillary first molars ) will be chosen and fitted on the teeth.
- Rubber base impression material will be taken with bands in place.
- Four metal bands will be placed in their relative positions in the impression and then poured up with stone.
- Send it to the LAB for appliance fabrication.
- At delivery day, the appliance will be cemented on the teeth by glass ionomer luting cement and two miniscrews will be placed in their positions, and activated by compressing the NiTi open coil spring, which apply 300g force. Patients will be monitored every 3 weeks.
- Conditions
- Maxillary First Molar Distalization
- Being tested
- Direct bone anchored pull distal slider, Indirect bone anchored dual force distalizer.
- Keywords
- orthodontics, miniscrews, distalization, direct anchorage, indirect anchorage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct bone anchored pull distal sliderDevice
distalization from the palatal side only.
Indirect bone anchored dual force distalizer.Device
distalization from the palatal and buccal sides.
| Study group | Role | What they receive |
|---|---|---|
| Direct bone anchored pull distal slider | Experimental | The appliance will be cemented on the maxillary first molars and two miniscrews will be placed in their positions. The appliance will be activated by closed coil spring, which apply 300g force. Receives: Device: Direct bone anchored pull distal slider |
| Indirect bone anchored dual force distalizer. | Experimental | The appliance will be cemented on the teeth and two miniscrews will be placed in their positions. Activated by compressing the NiTi open coil spring from the buccal and palatal sides. Receives: Device: Indirect bone anchored dual force distalizer. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anteroposterior skeletal measurements
From the lateral cephalometric, the maxillary and mandibular sagittal positions will be measured according to the SN plane, before and after distalization.
Measured: 8 months
Vertical skeletal measurements
From the lateral cephalometric, mandibular plane angle according to the SN plane and Frankfort horizontal plane, will be measured before and after distalization.
Measured: 8 months
Dental angular measurements
From the lateral cephalometric, the angle between teeth (maxillary central incisor, first premolar, second premolar, first molar) and the SN plane will be measured before and after distalization to measure the amount of tipping.
Measured: 8 months
Amount of distalization
From the lateral cephalometric, the distance between teeth (maxillary central incisor, first premolar, second premolar, first molar) and the pterygoid vertical (PTV) plane will be measured before and after distalization to calculate the amount of distalization in mm.
Measured: 8 months
Amount of intrusion
From the lateral cephalometric, the distance between teeth (maxillary central incisor, first premolar, second premolar, first molar) and the palatal plane (PP) will be measured before and after distalization to calculate the amount of intrusion in mm.
.
Measured: 8months
Amount of expansion
From the study model, the maxillary inter-canine, inter-first premolar, inter-second premolar, inter-first molar, and inter-second molar widths will be measured before and after distalization to calculate the amount of expansion in mm.
Measured: 8 months
Amount of rotation
From the study model, the angle between buccopalatal axis of teeth (maxillary first premolar, second premolar, first molar) and the midpalatal suture will be measured before and after distalization to calculate the amount of rotation.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2024
- Study start8 Jun 2023
- Primary completionAug 2024 (estimated)
- Study completionOct 2024 (estimated)
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 Maxillary First Molar DistalizationStudies 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
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeyad Mahmoud, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06507319
- Sponsor's protocol ID
- Doctor Zeyad Mahmoud Ali
- Status last verified
- Jul 2024
- First submitted
- 2 Jul 2024
- Last updated
- 18 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ali ZM, Shamaa MS, Mohammad MH. Comparison of direct and indirect skeletal anchorage for maxillary molar distalization in Class II malocclusion: A prospective clinical study. J World Fed Orthod. 2025 Oct;14(5):251-258. doi: 10.1016/j.ejwf.2025.05.002. Epub 2025 Jun 17.
PubMed 40533287
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation Of Two Bone-Anchored Maxillary Molar Distalization Appliances: Direct Versus Indirect Anchorage
- ClinicalTrials.gov ID
- NCT06507319
- Acronym / sponsor ID
- Doctor Zeyad Mahmoud Ali
- Conditions
- Maxillary First Molar Distalization
- Keywords
- orthodontics, miniscrews, distalization, direct anchorage, indirect anchorage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 8 Jun 2023 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 18 Jul 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.
Aim of study: this study will be conducted for Comparative Evaluation Of Two Bone-Anchored Maxillary Molar Distalization Appliances: Direct Versus Indirect Anchorage.
Material and methods: The study will consist of two groups, each group has 10 Patients. The patients will be selected from the outpatient clinic of the orthodontic department at Mansoura University.
Patients will be divided into 2 groups, group 1 will be treated by direct bone anchored pull distal slider, and group 2 by indirect bone anchored dual force distalizer.
Detailed description
Aim of study:
this study will be conducted for Comparative Evaluation Of Two Bone-Anchored Maxillary Molar Distalization Appliances: Direct Versus Indirect Anchorage.
Participant and eligibility criteria:
The study will consist of two groups, each group has 10 Patients. The patients will be selected from the outpatient clinic of the orthodontic department at Mansoura University. pretreatment records will be taken including: intraoral and extraoral photographs, study models, panoramic radiographs, and lateral cephalometric radiographs.
Intervention:
written and informed consents will be taken from the patients.
Group 1:
- Two metal bands will be chosen and fitted on the maxillary first molars.
- Rubber base impression material will be taken with bands in place.
- Two metal bands will be placed in their relative positions in the impression and then poured up with stone.
- Send it to the LAB for appliance fabrication.
- At delivery day, the appliance will be cemented on the maxillary first molars by glass ionomer luting cement and two miniscrews will be placed in their positions.
- The appliance will be activated by closed coil spring, which apply 300g force. Patients will be monitored every 3 weeks.
Group 2:
- Four metal bands ( two for maxillary first premolars and two for maxillary first molars ) will be chosen and fitted on the teeth.
- Rubber base impression material will be taken with bands in place.
- Four metal bands will be placed in their relative positions in the impression and then poured up with stone.
- Send it to the LAB for appliance fabrication.
- At delivery day, the appliance will be cemented on the teeth by glass ionomer luting cement and two miniscrews will be placed in their positions, and activated by compressing the NiTi open coil spring, which apply 300g force. Patients will be monitored every 3 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Direct bone anchored pull distal slider | Experimental | Device: Direct bone anchored pull distal sliderThe appliance will be cemented on the maxillary first molars and two miniscrews will be placed in their positions. The appliance will be activated by closed coil spring, which apply 300g force. |
| Indirect bone anchored dual force distalizer. | Experimental | Device: Indirect bone anchored dual force distalizer.The appliance will be cemented on the teeth and two miniscrews will be placed in their positions. Activated by compressing the NiTi open coil spring from the buccal and palatal sides. |
Who may qualify
- Ages
- 12 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Dental class II.
- No or mild to moderate maxillary teeth crowding.
- Erupted or partially erupted maxillary second molars.
- No previous orthodontic therapy.
- Absence or minimum crowding in the mandibular arch.
Key exclusion criteria (6 listed)
- Dental class I, III
- severe maxillary teeth crowding.
- Extracted or badly decayed maxillary first molars.
- Previous orthodontic therapy.
- Severe crowding in the mandibular arch.
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 |
|---|---|---|
| Direct bone anchored pull distal sliderdistalization from the palatal side only. | Device | Direct bone anchored pull distal slider |
| Indirect bone anchored dual force distalizer.distalization from the palatal and buccal sides. | Device | Indirect bone anchored dual force distalizer. |
Primary outcome
Anteroposterior skeletal measurements
Time frame: 8 months
From the lateral cephalometric, the maxillary and mandibular sagittal positions will be measured according to the SN plane, before and after distalization.
Vertical skeletal measurements
Time frame: 8 months
From the lateral cephalometric, mandibular plane angle according to the SN plane and Frankfort horizontal plane, will be measured before and after distalization.
Dental angular measurements
Time frame: 8 months
From the lateral cephalometric, the angle between teeth (maxillary central incisor, first premolar, second premolar, first molar) and the SN plane will be measured before and after distalization to measure the amount of tipping.
Amount of distalization
Time frame: 8 months
From the lateral cephalometric, the distance between teeth (maxillary central incisor, first premolar, second premolar, first molar) and the pterygoid vertical (PTV) plane will be measured before and after distalization to calculate the amount of distalization in mm.
Amount of intrusion
Time frame: 8months
From the lateral cephalometric, the distance between teeth (maxillary central incisor, first premolar, second premolar, first molar) and the palatal plane (PP) will be measured before and after distalization to calculate the amount of intrusion in mm. .
Amount of expansion
Time frame: 8 months
From the study model, the maxillary inter-canine, inter-first premolar, inter-second premolar, inter-first molar, and inter-second molar widths will be measured before and after distalization to calculate the amount of expansion in mm.
Amount of rotation
Time frame: 8 months
From the study model, the angle between buccopalatal axis of teeth (maxillary first premolar, second premolar, first molar) and the midpalatal suture will be measured before and after distalization to calculate the amount of rotation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2024.
- Derived from this study: PubMed 40533287Ali ZM, Shamaa MS, Mohammad MH. Comparison of direct and indirect skeletal anchorage for maxillary molar distalization in Class II malocclusion: A prospective clinical study. J World Fed Orthod. 2025 Oct;14(5):251-258. doi: 10.1016/j.ejwf.2025.05.002. Epub 2025 Jun 17.
- Individual participant dataSharing planned: No
Related trials for Maxillary First Molar Distalization
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Recruiting
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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 Direct bone anchored pull distal slider and Indirect bone anchored dual force distalizer. in people with Maxillary First Molar Distalization, 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 6 inclusion and 6 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 18 Jul 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?
Contact Zeyad M Ali, BDS (00201030172652 ext. 0020, zeyadqaddomy@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anteroposterior skeletal measurements (time frame: 8 months). The study lists 7 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 NCT06507319, 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 18 Jul 2024.