Class III MalocclusionNCT04229797
Mandibular First Molar Distalization
A study testing Mandibular distalization using extra-radicular miniscrews in people with Class III Malocclusion, run by Cairo University at 1 site in Egypt.
Trial summary
A clinical study to test the capability of the mini-screws inserted in the Mandibular buccal shelf area as an anchorage unit to distalize mandibular first molar for correction of mild to moderate Class III cases. Read more about this study
- Who is it for?
- Ages 16 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Class III Malocclusion
- What is being tested?
- Mandibular distalization using extra-radicular miniscrews
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- Dec 2024to Mar 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 24 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Class III dental incisal relation.
- Dental canine and molar relation not more than half unit Class III.
- Presence of unerupted mandibular third molars on both sides.
- Skeletal Class I or mild Class III.
- Full Permanent dentition.
- Medically free subjects.
Who cannot join
- Patients with systemic diseases or neuromuscular disorders.
- Retroclined lower incisors.
- Sever skeletal dysplasia.
- Patients with periodontal disease.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentistry, Cairo University
Cairo, Giza Governorate, 12411
Mohamed Kh Makhlouf, +201001405334, mmakhlouf@gmail.com
About this study
Official title: The Efficacy of Mandibular First Molar Distalization Using Extra Radicular Miniscrews in Class III Patients: A Randomized Clinical Trial
A clinical study to test the capability of the mini-screws inserted in the Mandibular buccal shelf area as an anchorage unit to distalize mandibular first molar for correction of mild to moderate Class III cases. The second aim was to detect if there is a difference in the amount of distalization in the presence of unerupted mandibular third molars, using the same technique.
Read the detailed description
Class III malocclusion in adults is one of the most complex malocclusions in clinical orthodontics. For adults, the ideal treatment option for Class III malocclusion is accomplished either by camouflage treatment in mild to moderate cases or orthognathic surgery in severe cases. Camouflage treatment for Class III malocclusion comprises three main techniques; Class III elastics, mandibular first molar distalization, or extraction of mandibular first premolars. Mandibular first molar distalization via the use of skeletal anchorage has the problem of increased failure rate of the inter-radicular temporary anchorage devices (TADs). Accordingly, a randomized clinical trial using extra radicular TADs in the Mandibular buccal shelf area was designed in the current research aiming to test the efficacy of such a technique in inducing mandibular molar distalization with decreased failure rate, and whether the presence of unerupted mandibular third molars will affect the distalization movement or not.
- Conditions
- Class III Malocclusion
- Being tested
- Mandibular distalization using extra-radicular miniscrews
- Keywords
- Class III malocclusion, Mandibular buccal shelf, Mini-screws, Extra-radicular mini-screws, Distalization, Temporary Anchorage device
- Medical subject headings
- Malocclusion, Angle Class III
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mandibular distalization using extra-radicular miniscrewsProcedure or surgery
Distalization of the Mandibular first molars using mandibular buccal shelf mini-screws in the presence of unerupted third molars
| Study group | Role | What they receive |
|---|---|---|
| Comparator | Active comparator | Extraction of the unerupted third molars before distalization of mandibular first molar using Mandibular buccal shelf mini-screws. Receives: Procedure: Mandibular distalization using extra-radicular miniscrews |
| Intervention | Experimental | Leaving the unerupted third molars and distalizing using Mandibular buccal shelf mini-screws. Receives: Procedure: Mandibular distalization using extra-radicular miniscrews |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dental effect
Amount of first mandibular molar distalization (mm) in the two groups, A cephalometric of pre and post distalization digital cephalograms will be traced, landmarks and reference lines will be determined; skeleto-dental and soft tissue measurements will be performed using Quick-Ceph program .
Digital models of pre and post distalization will be superimposed and measured for dental changes using Anatomage program.
Measured: 6 months
Secondary outcomes (1)
Skeletal and soft tissue effect
Skeletal and soft tissue changes post distalization, A cephalometric of pre and post distalization digital cephalograms will be traced, landmarks and reference lines will be determined; skeleto-dental and soft tissue measurements will be performed using Quick-Ceph program.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study startDec 2024 (estimated)
- Primary completionFeb 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Class III MalocclusionStudies 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
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Khaled Makhlouf, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04229797
- Sponsor's protocol ID
- MakhloufOrth
- Status last verified
- Feb 2024
- First submitted
- 10 Jan 2020
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Mandibular First Molar Distalization Using Extra Radicular Miniscrews in Class III Patients: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04229797
- Acronym / sponsor ID
- MakhloufOrth
- Conditions
- Class III Malocclusion
- Keywords
- Class III malocclusion, Mandibular buccal shelf, Mini-screws, Extra-radicular mini-screws, Distalization, Temporary Anchorage device
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Dec 2024 (estimated)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 18 Jan 2020 (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.
A clinical study to test the capability of the mini-screws inserted in the Mandibular buccal shelf area as an anchorage unit to distalize mandibular first molar for correction of mild to moderate Class III cases. The second aim was to detect if there is a difference in the amount of distalization in the presence of unerupted mandibular third molars, using the same technique.
Detailed description
Class III malocclusion in adults is one of the most complex malocclusions in clinical orthodontics. For adults, the ideal treatment option for Class III malocclusion is accomplished either by camouflage treatment in mild to moderate cases or orthognathic surgery in severe cases. Camouflage treatment for Class III malocclusion comprises three main techniques; Class III elastics, mandibular first molar distalization, or extraction of mandibular first premolars. Mandibular first molar distalization via the use of skeletal anchorage has the problem of increased failure rate of the inter-radicular temporary anchorage devices (TADs). Accordingly, a randomized clinical trial using extra radicular TADs in the Mandibular buccal shelf area was designed in the current research aiming to test the efficacy of such a technique in inducing mandibular molar distalization with decreased failure rate, and whether the presence of unerupted mandibular third molars will affect the distalization movement or not.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Comparator | Active comparator | Procedure: Mandibular distalization using extra-radicular miniscrewsExtraction of the unerupted third molars before distalization of mandibular first molar using Mandibular buccal shelf mini-screws. |
| Intervention | Experimental | Procedure: Mandibular distalization using extra-radicular miniscrewsLeaving the unerupted third molars and distalizing using Mandibular buccal shelf mini-screws. |
Who may qualify
- Ages
- 16 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Class III dental incisal relation.
- Dental canine and molar relation not more than half unit Class III.
- Presence of unerupted mandibular third molars on both sides.
- Skeletal Class I or mild Class III.
- Full Permanent dentition.
Key exclusion criteria (4 listed)
- Patients with systemic diseases or neuromuscular disorders.
- Retroclined lower incisors.
- Sever skeletal dysplasia.
- Patients with periodontal disease.
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 |
|---|---|---|
| Mandibular distalization using extra-radicular miniscrewsDistalization of the Mandibular first molars using mandibular buccal shelf mini-screws in the presence of unerupted third molars | Procedure or surgery | Comparator, Intervention |
Primary outcome
Dental effect
Time frame: 6 months
Amount of first mandibular molar distalization (mm) in the two groups, A cephalometric of pre and post distalization digital cephalograms will be traced, landmarks and reference lines will be determined; skeleto-dental and soft tissue measurements will be performed using Quick-Ceph program . Digital models of pre and post distalization will be superimposed and measured for dental changes using Anatomage program.
1 secondary outcome
Skeletal and soft tissue effect
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mandibular distalization using extra-radicular miniscrews in people with Class III Malocclusion, 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 6 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 7 Feb 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 Mohamed Kh Makhlouf (=201001405334, mmakhlouf@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dental effect (time frame: 6 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 7 Feb 2024.