Posterior CrossbiteNCT03772379
Evaluation of Rapid Maxillary Expansion Facilitated by Micro-osteoperforation in Adolescent Patients With Skeletal Maxillary Constriction
A study testing tooth borne hyrax expander and microosteoperforation in people with Posterior Crossbite, run by Cairo University.
Trial summary
The aim of this study is to evaluate and compare the effect of rapid maxillary expansion with and without microosteoperforation in patients with skeletal maxillary constriction.Theoretically, the force generated by the activation of the Hyrax expander leads initially to the compression of the periodontal ligament… Read more about this study
- Who is it for?
- Ages 11 to 14 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Posterior Crossbite
- What is being tested?
- tooth borne hyrax expander and microosteoperforation
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- Feb 2019to May 2020
- 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 14 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- Female adolescent patients with an age range 11- 14 years.
- Having apical constricted maxillary arch reflected by posterior cross-bite and verified through Howe's analysis on the dental study models.
- Normal vertical growth pattern.
- Fully erupted maxillary first premolars and first permanent molars.
Who cannot join
- Previous orthodontic treatment.
- Any congenital anomalies, systemic disease, or asymmetries that might have an influence on tooth movement.
- Active periodontal affection or severe gingival inflammation.
About this study
The aim of this study is to evaluate and compare the effect of rapid maxillary expansion with and without microosteoperforation in patients with skeletal maxillary constriction.Theoretically, the force generated by the activation of the Hyrax expander leads initially to the compression of the periodontal ligament, bending of the alveolar bone, and tipping of the anchor teeth. This in turn contributes to the unfavorable changes in the supporting tissues; such as root resorption, buccal crown tipping, reduction of buccal bone thickness, marginal bone loss and alveolar bone fenestration and dehiscence. In this trial, it is assumed that by reducing the cortical bone resistance, using micro-osteoperforation (MOP), the alveolar bone bending and buccal tipping that usually occur during expansion will be reduced and thus facilitating the bone expansion.
Read the detailed description
The study consists of 2 groups that are divided divided equally and randomly.The first group will receive a tooth borne Hyrax expander supported on first premolar and first permanent molar , whereas the second group will receive the same appliance associated with microosteoperforation(MOP). The MOP will be performed on the buccal segment bilaterally along the maxilla starting from the distal of the canine till the distal of the first permanent molar. The assessment will be done using CBCT scans immediately after expansion and 6 months postretention.
- Conditions
- Posterior Crossbite
- Being tested
- tooth borne hyrax expander, microosteoperforation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tooth borne hyrax expanderDevice
ready made four stainless steel bands will be supported on the first premolars and first permanent molars and to which the palatal expander will be soldered to form the Hyrax,.The appliance will be activated one quarter turn per day untill reaching maximum amount of lateral expansion of the jack screw. the patients will be recalled twice per week to evaluate the progress of treatment.
microosteoperforationProcedure or surgery
ready made four stainless steel bands supported on the first premolars and first permanent molars and to which the palatal expander will be soldered to form the Hyrax.No activation will be provided to the hyrax expander before the micro-osteoperforation is performed.
Microosteoperforation will applied bilaterally on the buccal surface between the roots of teeth at the level of mucoginival junction, starting from the distal of canine till the distal of the first permanent molar using a small sized surgical bur mounted on a hand piece .
| Study group | Role | What they receive |
|---|---|---|
| tooth borne hyrax expander group | Experimental | patients of this group will receive a tooth borne hyrax expander anchored to the first premolars and first permanent molars . Receives: Device: tooth borne hyrax expander |
| tooth borne hyrax expander with microosteoperforation | Experimental | patients of this group will receive a tooth borne hyrax expander anchored to the first premolars and first permanent molars and microosteoperforation . Receives: Procedure: microosteoperforation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dental tipping.
it will be measured in degree on Cone beam computed tomography image using a software
Measured: an average1 year
Alveolar bending
it will be measured in degree on Cone beam computed tomography image using a software
Measured: an average1 year
Dental changes(transverse).
it will be measured in mm on Cone beam computed tomography image using a software
Measured: an average1 year
Skeletal changes(transverse, anteroposterior and vertical)
it will be measured in mm on Cone beam computed tomography image using a software
Measured: an average1 year
Secondary outcomes (1)
Pattern of expansion
it will be assessed on Cone beam computed tomography image and in mm clinically with boley gauge.
Measured: an average1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2018
- Study startFeb 2019 (estimated)
- Primary completionFeb 2020 (estimated)
- Study completionMay 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posterior CrossbiteStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mennatallah Ihab Elsayed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03772379
- Sponsor's protocol ID
- PhD Protocol
- Status last verified
- Dec 2018
- First submitted
- 27 Nov 2018
- Last updated
- 11 Dec 2018
- 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 11 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Rapid Maxillary Expansion Facilitated by Micro-osteoperforation in Adolescent Patients With Skeletal Maxillary Constriction
- ClinicalTrials.gov ID
- NCT03772379
- Acronym / sponsor ID
- PhD Protocol
- Conditions
- Posterior Crossbite
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Feb 2019 (estimated)
- Primary completion
- Feb 2020 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 11 Dec 2018 (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.
The aim of this study is to evaluate and compare the effect of rapid maxillary expansion with and without microosteoperforation in patients with skeletal maxillary constriction.Theoretically, the force generated by the activation of the Hyrax expander leads initially to the compression of the periodontal ligament, bending of the alveolar bone, and tipping of the anchor teeth. This in turn contributes to the unfavorable changes in the supporting tissues; such as root resorption, buccal crown tipping, reduction of buccal bone thickness, marginal bone loss and alveolar bone fenestration and dehiscence. In this trial, it is assumed that by reducing the cortical bone resistance, using micro-osteoperforation (MOP), the alveolar bone bending and buccal tipping that usually occur during expansion will be reduced and thus facilitating the bone expansion.
Detailed description
The study consists of 2 groups that are divided divided equally and randomly.The first group will receive a tooth borne Hyrax expander supported on first premolar and first permanent molar , whereas the second group will receive the same appliance associated with microosteoperforation(MOP). The MOP will be performed on the buccal segment bilaterally along the maxilla starting from the distal of the canine till the distal of the first permanent molar. The assessment will be done using CBCT scans immediately after expansion and 6 months postretention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tooth borne hyrax expander group | Experimental | Device: tooth borne hyrax expanderpatients of this group will receive a tooth borne hyrax expander anchored to the first premolars and first permanent molars . |
| tooth borne hyrax expander with microosteoperforation | Experimental | Procedure: microosteoperforationpatients of this group will receive a tooth borne hyrax expander anchored to the first premolars and first permanent molars and microosteoperforation . |
Who may qualify
- Ages
- 11 to 14 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Female adolescent patients with an age range 11- 14 years.
- Having apical constricted maxillary arch reflected by posterior cross-bite and verified through Howe's analysis on the dental study models.
- Normal vertical growth pattern.
- Fully erupted maxillary first premolars and first permanent molars.
Key exclusion criteria (3 listed)
- Previous orthodontic treatment.
- Any congenital anomalies, systemic disease, or asymmetries that might have an influence on tooth movement.
- Active periodontal affection or severe gingival inflammation.
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 |
|---|---|---|
| tooth borne hyrax expanderready made four stainless steel bands will be supported on the first premolars and first permanent molars and to which the palatal expander will be soldered to form the Hyrax,.The appliance will be activated one quarter turn per day untill reaching maximum amount of lateral expansion of the jack screw. the patients will be recalled twice per week to evaluate the progress of treatment. | Device | tooth borne hyrax expander group |
| microosteoperforationready made four stainless steel bands supported on the first premolars and first permanent molars and to which the palatal expander will be soldered to form the Hyrax.No activation will be provided to the hyrax expander before the micro-osteoperforation is performed. Microosteoperforation will applied bilaterally on the buccal surface between the roots of teeth at the level of mucoginival junction, starting from the distal of canine till the distal of the first permanent molar using a small sized surgical bur mounted on a hand piece . | Procedure or surgery | tooth borne hyrax expander with microosteoperforation |
Primary outcome
Dental tipping.
Time frame: an average1 year
it will be measured in degree on Cone beam computed tomography image using a software
Alveolar bending
Time frame: an average1 year
it will be measured in degree on Cone beam computed tomography image using a software
Dental changes(transverse).
Time frame: an average1 year
it will be measured in mm on Cone beam computed tomography image using a software
Skeletal changes(transverse, anteroposterior and vertical)
Time frame: an average1 year
it will be measured in mm on Cone beam computed tomography image using a software
1 secondary outcome
Pattern of expansion
Time frame: an average1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2018.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing tooth borne hyrax expander and microosteoperforation in people with Posterior Crossbite, run by Cairo University.
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 3 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 11 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Dental tipping. (time frame: an average1 year). The study lists 4 primary outcomes in all. 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 11 Dec 2018.