MalocclusionNCT04884022
Effectiveness of Two Skeletally Anchored Force Mechanics for Skeletal Class II Correction in Growing Patients
A study testing Miniplates in mandibular symphysis & infrazygomatic and Miniplates in external oblique ridge & anterior maxillary region in people with Malocclusion, run by Alexandria University at 1 site in Egypt.
Trial summary
Patients with skeletal Class II malocclusion due to mandibular retrognathism will be recruited and randomly allocated to three equal groups. first group will be treated by pushing orthopedic force mechanics, second group will be treated by pulling orthopedic force mechanics, and third group will be observed for 9… Read more about this study
- Who is it for?
- Ages 11 to 13 years
- Conditions the study is for
- Malocclusion
- What is being tested?
- Miniplates in mandibular symphysis & infrazygomatic and Miniplates in external oblique ridge & anterior maxillary region
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteEgypt
- Study dates
- 8 Mar 2021to 1 Dec 2022
- 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 11 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Chronological age ranges from 11 years to 13 years.
- Skeletal Class II malocclusion with a deficient mandible (SNB ≤ 76°).
- Horizontal growth pattern (MP/SN ≤ 39°).
- Angle Class II division 1 malocclusion with at least 5 mm overjet.
- Mandibular arch crowding less than 5 mm.
- The patients have to be in the prepubertal growth stage (cervical maturational stage 3 or 4) when applying orthopedic force.
- Patients with good oral hygiene, and a healthy periodontal condition.
Who cannot join
- Patients who underwent previous orthodontic treatment.
- Patients with previous craniofacial surgeries, chronic diseases, syndromes, or growth problems that may affect bone.
- Any signs or symptoms of para-functional habits or previous history of temporomandibular disorders.
- Extracted or missing upper permanent teeth (except for third molars).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Two Skeletally Anchored Force Mechanics for Correction of Skeletal Class II Malocclusion in Growing Patients (A Randomized Controlled Clinical Trial)
Patients with skeletal Class II malocclusion due to mandibular retrognathism will be recruited and randomly allocated to three equal groups. first group will be treated by pushing orthopedic force mechanics, second group will be treated by pulling orthopedic force mechanics, and third group will be observed for 9 months to detect the natural growth changes. Skeletal changes will be evaluated and the treatment changes will be compared with the natural growth changes. The study hypothesis is that use of direct bimaxillary miniplate anchorage in conjunction with fixed functional appliance (pushing orthopedic force) or closed coil spring (pulling orthopedic force) will induce statistically significant skeletal mandibular growth in comparison to natural mandibular growth changes.
Read the detailed description
A randomized controlled clinical trial will be conducted to address the aim of the study. Thirty-nine growing patients with skeletal Class II malocclusion due to mandibular retrognathism will be recruited. The sample will be randomly allocated to three equal groups, each including thirteen subjects. Group A will be treated by pushing orthopedic force mechanics using fixed functional appliance (Sabbagh Advanced Repositioning Appliance) anchored to four miniplates (two miniplates inserted in the mandibular symphysis and two infrazygomatic miniplates), and Group B, will be treated by pulling orthopedic force mechanics using Class II springs (CS Class II correction device) anchored to four miniplates (two inserted in the mandibular posterior buccal segment and two inserted in the maxillary anterior segment). In both groups, the appliances will be removed after reaching an edge-to-edge incisor relationship or after 9 months, whichever happens first. A similar third group (Group C) will be observed for 9 months to detect the natural growth changes. Skeletal changes will be evaluated using pretreatment and posttreatment cone beam computed tomography scans (CBCT). The treatment changes will be compared with the natural growth changes observed in group C. Other variables will be also examined including, the dentoalveolar effects, the soft tissue profile, and the patient's acceptance to this treatment modality.
- Conditions
- Malocclusion
- Being tested
- Miniplates in mandibular symphysis & infrazygomatic, Miniplates in external oblique ridge & anterior maxillary region
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Miniplates in mandibular symphysis & infrazygomaticProcedure or surgery
Fixed functional appliance (pushing orthopedic force) in conjunction with direct skeletal anchorage
Miniplates in external oblique ridge & anterior maxillary regionProcedure or surgery
Coil spring (pulling orthopedic force) in conjunction with direct skeletal anchorage
| Study group | Role | What they receive |
|---|---|---|
| Miniplates in mandibular symphysis & infrazygomatic | Experimental | Not described Receives: Procedure: Miniplates in mandibular symphysis & infrazygomatic |
| Miniplates in external oblique ridge & anterior maxillary region | Active comparator | Not described Receives: Procedure: Miniplates in external oblique ridge & anterior maxillary region |
| Growing skeletal Class II subjects | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in the effective mandibular length (Co-Gn)
Correction of the skeletal Class II relation. This outcome will be detected by measuring the mean change in the effective mandibular length (Co-Gn) and position on CBCT images from baseline data (T1) and after appliance removal (T2) and will be compared with the growth changes observed in the control group
Measured: at baseline and after treatment completion about 9 months
Secondary outcomes (3)
change in maxillary length (Co-A)
The effective maxillary length (Co-A) and position changes will be measured after and chin will be measured.
Measured: at baseline and after treatment completion about 9 months
Changes in the soft tissue angle of convexity
the position of the upper and lower lips, and chin will be measured.
Measured: at baseline and after treatment completion about 9 months
patient acceptance of treatment
The patient's acceptance to the treatment will be evaluated using a visual analog scale questionnaire after removal of the appliances.
Measured: After treatment completion about 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2021
- Study start8 Mar 2021
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalocclusionStudies of the same condition, open and under way.
- More trials run by Alexandria 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasmine Mohamed Sayed Mahmoud, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04884022
- Sponsor's protocol ID
- Anchored force mechanices
- Status last verified
- Jul 2022
- First submitted
- 24 Apr 2021
- Last updated
- 27 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Two Skeletally Anchored Force Mechanics for Correction of Skeletal Class II Malocclusion in Growing Patients (A Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT04884022
- Acronym / sponsor ID
- Anchored force mechanices
- Conditions
- Malocclusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 8 Mar 2021 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 12 May 2021 (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.
Patients with skeletal Class II malocclusion due to mandibular retrognathism will be recruited and randomly allocated to three equal groups. first group will be treated by pushing orthopedic force mechanics, second group will be treated by pulling orthopedic force mechanics, and third group will be observed for 9 months to detect the natural growth changes. Skeletal changes will be evaluated and the treatment changes will be compared with the natural growth changes. The study hypothesis is that use of direct bimaxillary miniplate anchorage in conjunction with fixed functional appliance (pushing orthopedic force) or closed coil spring (pulling orthopedic force) will induce statistically significant skeletal mandibular growth in comparison to natural mandibular growth changes.
Detailed description
A randomized controlled clinical trial will be conducted to address the aim of the study. Thirty-nine growing patients with skeletal Class II malocclusion due to mandibular retrognathism will be recruited. The sample will be randomly allocated to three equal groups, each including thirteen subjects. Group A will be treated by pushing orthopedic force mechanics using fixed functional appliance (Sabbagh Advanced Repositioning Appliance) anchored to four miniplates (two miniplates inserted in the mandibular symphysis and two infrazygomatic miniplates), and Group B, will be treated by pulling orthopedic force mechanics using Class II springs (CS Class II correction device) anchored to four miniplates (two inserted in the mandibular posterior buccal segment and two inserted in the maxillary anterior segment). In both groups, the appliances will be removed after reaching an edge-to-edge incisor relationship or after 9 months, whichever happens first. A similar third group (Group C) will be observed for 9 months to detect the natural growth changes. Skeletal changes will be evaluated using pretreatment and posttreatment cone beam computed tomography scans (CBCT). The treatment changes will be compared with the natural growth changes observed in group C. Other variables will be also examined including, the dentoalveolar effects, the soft tissue profile, and the patient's acceptance to this treatment modality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Miniplates in mandibular symphysis & infrazygomatic | Experimental | Procedure: Miniplates in mandibular symphysis & infrazygomatic |
| Miniplates in external oblique ridge & anterior maxillary region | Active comparator | Procedure: Miniplates in external oblique ridge & anterior maxillary region |
| Growing skeletal Class II subjects | No intervention | – |
Who may qualify
- Ages
- 11 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Chronological age ranges from 11 years to 13 years.
- Skeletal Class II malocclusion with a deficient mandible (SNB ≤ 76°).
- Horizontal growth pattern (MP/SN ≤ 39°).
- Angle Class II division 1 malocclusion with at least 5 mm overjet.
- Mandibular arch crowding less than 5 mm.
Key exclusion criteria (4 listed)
- Patients who underwent previous orthodontic treatment.
- Patients with previous craniofacial surgeries, chronic diseases, syndromes, or growth problems that may affect bone.
- Any signs or symptoms of para-functional habits or previous history of temporomandibular disorders.
- Extracted or missing upper permanent teeth (except for third molars).
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 |
|---|---|---|
| Miniplates in mandibular symphysis & infrazygomaticFixed functional appliance (pushing orthopedic force) in conjunction with direct skeletal anchorage | Procedure or surgery | Miniplates in mandibular symphysis & infrazygomatic |
| Miniplates in external oblique ridge & anterior maxillary regionCoil spring (pulling orthopedic force) in conjunction with direct skeletal anchorage | Procedure or surgery | Miniplates in external oblique ridge & anterior maxillary region |
Primary outcome
change in the effective mandibular length (Co-Gn)
Time frame: at baseline and after treatment completion about 9 months
Correction of the skeletal Class II relation. This outcome will be detected by measuring the mean change in the effective mandibular length (Co-Gn) and position on CBCT images from baseline data (T1) and after appliance removal (T2) and will be compared with the growth changes observed in the control group
3 secondary outcomes
change in maxillary length (Co-A)
Time frame: at baseline and after treatment completion about 9 months
Changes in the soft tissue angle of convexity
Time frame: at baseline and after treatment completion about 9 months
patient acceptance of treatment
Time frame: After treatment completion about 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2022.
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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 Miniplates in mandibular symphysis & infrazygomatic and Miniplates in external oblique ridge & anterior maxillary region in people with Malocclusion, run by Alexandria 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 7 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 27 Jul 2022. 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?
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?
change in the effective mandibular length (Co-Gn) (time frame: at baseline and after treatment completion about 9 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 27 Jul 2022.