OrthodonticsNCT02901678
The Effect of Different Force Magnitudes on Maxillary Posterior Segment Intrusion
A study testing Intrusion by 400 g in people with Orthodontics, run by Cairo University at 1 site in Egypt.
Trial summary
A Randomized clinical trial comparing two different force magnitudes in maxillary posterior segment intrusion in adult patients with skeletal open bite malocclusion Read more about this study
- Who is it for?
- Ages 15 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Orthodontics
- What is being tested?
- Intrusion by 400 g
- 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
- Nov 2015to Apr 2018
- 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 15 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Adult patients with an age range from 17 to 25.
- Skeletal open bite.
- Dental open bite that is due to overgrowth of maxillary posterior segment as seen clinically and that can be corrected without surgical intervention (a minimum of 3 mm and a maximum of 8 mm).
- Skeletal class I or mild to moderate skeletal class II that enables camouflage treatment.
- Normal incisor show on smiling (that makes the case indicated for molar intrusion and not for incisor extrusion).
- Full set of maxillary posterior dentition (first and second premolars, first molars at least).
- No previous orthodontic treatment.
Who cannot join
- Medically compromised patients.
- Patients suffering from any congenital or hereditary diseases.
- Smoking or any systemic diseases.
- Chronic use of any medications including antibiotics, phenytoin, cyclosporin, anti-inflammatory drugs, systemic corticosteroids, and calcium channel blockers.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Two Different Force Magnitudes on Maxillary Posterior Segment Intrusion in Adult Patients With Skeletal Open Bite Using Temporary Anchorage Devices- A Randomized Clinical Trial
A Randomized clinical trial comparing two different force magnitudes in maxillary posterior segment intrusion in adult patients with skeletal open bite malocclusion
Read the detailed description
This randomized controlled trial is aiming to study the effect of the different force magnitude on maxillary posterior segment intrusion. Two groups are going to be allocated and the amount and rate of intrusion will be measured and compared.
- Conditions
- Orthodontics
- Being tested
- Intrusion by 400 g
- Keywords
- skelatal open bite, posterior intrusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrusion by 400 gDevice
using miniscrews and coil springs to apply the intrusive force on maxillary posterior segment intrusion.
| Study group | Role | What they receive |
|---|---|---|
| Intrusion by 200 g | Active comparator | Applying 200 g intrusive force for the maxillary posterior segment intrusion using miniscrews Receives: Device: Intrusion by 400 g |
| Intrusion by 400 g | Experimental | Applying 400 g of Intrusive force for the maxillary posterior segment intrusion using miniscrews Receives: Device: Intrusion by 400 g |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of intrusion
The amount the upper posterior teeth have been intruded.
Measured: 6 months
Rate of bite closure
The rate by which the open bite closes as a result of posterior segment intrusion
Measured: 6 months
Secondary outcomes (3)
Average rate of intrusion
The amount of intrusion divided by the duration of intrusion
Measured: 6 months
Root resorption
The amount of root resorption as a result of the intrusive force
Measured: 6 months
Tipping
The amount of mesiodistal and buccolingual tipping of posterior teeth
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 posted15 Sep 2016 (estimated)
- Study startNov 2015
- Primary completionApr 2018
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OrthodonticsStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba El-Sayed Kamel Akl, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02901678
- Sponsor's protocol ID
- 121888
- Status last verified
- Aug 2018
- First submitted
- 10 Sep 2016
- Last updated
- 2 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: Participants data will not be exposed except for research committee
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Two Different Force Magnitudes on Maxillary Posterior Segment Intrusion in Adult Patients With Skeletal Open Bite Using Temporary Anchorage Devices- A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02901678
- Acronym / sponsor ID
- 121888
- Conditions
- Orthodontics
- Keywords
- skelatal open bite, posterior intrusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 15 Sep 2016 (estimated)
- 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 Randomized clinical trial comparing two different force magnitudes in maxillary posterior segment intrusion in adult patients with skeletal open bite malocclusion
Detailed description
This randomized controlled trial is aiming to study the effect of the different force magnitude on maxillary posterior segment intrusion. Two groups are going to be allocated and the amount and rate of intrusion will be measured and compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intrusion by 200 g | Active comparator | Device: Intrusion by 400 gApplying 200 g intrusive force for the maxillary posterior segment intrusion using miniscrews |
| Intrusion by 400 g | Experimental | Device: Intrusion by 400 gApplying 400 g of Intrusive force for the maxillary posterior segment intrusion using miniscrews |
Who may qualify
- Ages
- 15 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Adult patients with an age range from 17 to 25.
- Skeletal open bite.
- Dental open bite that is due to overgrowth of maxillary posterior segment as seen clinically and that can be corrected without surgical intervention (a minimum of 3 mm and a maximum of 8 mm).
- Skeletal class I or mild to moderate skeletal class II that enables camouflage treatment.
- Normal incisor show on smiling (that makes the case indicated for molar intrusion and not for incisor extrusion).
Key exclusion criteria (4 listed)
- Medically compromised patients.
- Patients suffering from any congenital or hereditary diseases.
- Smoking or any systemic diseases.
- Chronic use of any medications including antibiotics, phenytoin, cyclosporin, anti-inflammatory drugs, systemic corticosteroids, and calcium channel blockers.
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 |
|---|---|---|
| Intrusion by 400 gusing miniscrews and coil springs to apply the intrusive force on maxillary posterior segment intrusion. | Device | Intrusion by 200 g, Intrusion by 400 g |
Primary outcome
Amount of intrusion
Time frame: 6 months
The amount the upper posterior teeth have been intruded.
Rate of bite closure
Time frame: 6 months
The rate by which the open bite closes as a result of posterior segment intrusion
3 secondary outcomes
Average rate of intrusion
Time frame: 6 months
Root resorption
Time frame: 6 months
Tipping
Time frame: 6 months
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 2 Aug 2018.
- Individual participant dataSharing planned: No. Participants data will not be exposed except for research committee
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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 Intrusion by 400 g in people with Orthodontics, 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 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: finished, as of the sponsor's last update on 2 Aug 2018. 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?
Amount of intrusion (time frame: 6 months). The study lists 2 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 2 Aug 2018.