Class II MalocclusionNCT05592977
Effect of Bilateral Distalization of Upper First Molars in a Group of Patients After Extraction of Maxillary Second Molars
A study testing Intra-Oral Distalizing Device in people with Class II Malocclusion, run by Future University in Egypt at 1 site in Egypt.
Trial summary
There is a scarcity in the current literature regarding such appliance and its effect on distalizing the first maxillary molar in absence of the second molar. Therefore, this study was made to evaluate the effect of bilateral distalization of upper first molars in a group of patients after extraction of maxillary… Read more about this study
- Who is it for?
- Ages 16 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Class II Malocclusion
- What is being tested?
- Intra-Oral Distalizing Device
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 9 Nov 2020to 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 16 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Female Patients with cervical vertebra maturation index (CVMI) 5 \& 6.
- From quarter unit to 3\4-unit class II molar relationship.
- An overjet of an average 6mm.
- Full Set of permanent dentition except for the maxillary second molar.
- Favorable path of eruption for the maxillary third molar.
Who cannot join
- Medically compromised Patients.
- Patients under long term medications.
- Patients having sever periodontal disease.
- CVMI 3 or less
- Full unit class II cases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Bilateral Distalization of Upper First Molars in a Group of Patients After Extraction of Maxillary Second Molars Using Infra Zygomatic Mini Implants: A Prospective Clinical Trial
There is a scarcity in the current literature regarding such appliance and its effect on distalizing the first maxillary molar in absence of the second molar. Therefore, this study was made to evaluate the effect of bilateral distalization of upper first molars in a group of patients after extraction of maxillary second Molars using infra zygomatic mini implants.
Read the detailed description
The appliances available for distalization used to be mainly extraoral distalizing appliances which depended entirely on patient cooperation and compliance. Even after the emergence of intra-oral distalizing appliances they had adverse dentoalveolar effect such as anchorage loss and flaring of the upper anterior teeth. Thus, this study was made in order to evaluate the efficiency of our proposed appliance in the treatment of Class II patients while avoiding the adverse effects mentioned above.
- Conditions
- Class II Malocclusion
- Being tested
- Intra-Oral Distalizing Device
- Keywords
- Intermolar Width, Molar Inclination, Intra-oral Appliance, Infrazygomatic Mini-screws, Distalization
- Medical subject headings
- Overbite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-Oral Distalizing DeviceDevice
The inner bow (1.2mm) is a modified version of the inner part of a conventional face bow. Two hooks were soldered onto the inner bow distal to the lateral incisor teeth regions, and U loop at 1st premolar region, and bends acting as mesial stop will be bent in front of the maxillary first molars. The anterior component of the inner bow is 3 mm free from the labial surface of anterior teeth
| Study group | Role | What they receive |
|---|---|---|
| Intra-oral Distalizing Appliance | Experimental | Two infra zygomatic mini-implants will be placed Bands will be cemented to upper first molars. The inner bow (1.2mm) is a modified version of the inner part of a conventional face bow. Two hooks were soldered onto the inner bow distal to the lateral incisor teeth regions, and U loop at 1st premolar region, and bends acting as mesial stop will be bent in front of the maxillary first molars.
Orthodontic force 300 mg per side Will be delivered by Niti closed coil spring which is attached from infra zygomatic mini screw to the hook soldered to the wire framework. Receives: Device: Intra-Oral Distalizing Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
linear distalization of maxillary 1st molar.
Efficiency of the proposed appliance to induce distalization of the upper 1st molar measured on Scanned dental casts as well as cone-beam computed tomography (CBCT) in millimetres.
Measured: Up until Class I Molar Relation (a maximum of 8 months regardless)
Rate of maxillary 1st molar Distalization in mm/ month.
Efficiency of the proposed appliance to induce distalization of the upper 1st molar measured on Scanned dental casts with a monthly follow up in millimetres.
Measured: Up until Class I Molar Relation (a maximum of 8 months regardless)
Secondary outcomes (2)
Changes in Intermolar width in mm.
Effect of the proposed appliance on the transverse Dental changes in the upper buccal segment through scanned dental cast in millimetres
Measured: Up until Class I Molar Relation (a maximum of 8 months regardless)
Changes of Molar inclination in degrees.
Effect of the proposed appliance on the angulation of the first permanent molar through scanned dental cast and cone-beam computed tomography (CBCT) in degrees.
Measured: Up until Class I Molar Relation (a maximum of 8 months regardless)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2022
- Study start9 Nov 2020
- Primary completion1 Nov 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Class II MalocclusionStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Future University in Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hosam Abdullah Mohamed Zaza, Future University in Egypt
- Investigators
- Yehia Mostafa, Professr and Chairman, Study director, Future University in Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05592977
- Sponsor's protocol ID
- FUE.REC(23)/11-2020
- Status last verified
- Feb 2023
- First submitted
- 5 Jun 2021
- Last updated
- 17 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected individual participant data (IPD)
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Bilateral Distalization of Upper First Molars in a Group of Patients After Extraction of Maxillary Second Molars Using Infra Zygomatic Mini Implants: A Prospective Clinical Trial
- ClinicalTrials.gov ID
- NCT05592977
- Acronym / sponsor ID
- FUE.REC(23)/11-2020
- Conditions
- Class II Malocclusion
- Keywords
- Intermolar Width, Molar Inclination, Intra-oral Appliance, Infrazygomatic Mini-screws, Distalization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Future University in EgyptUniversity, hospital or other
- Study start
- 9 Nov 2020 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 25 Oct 2022 (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.
There is a scarcity in the current literature regarding such appliance and its effect on distalizing the first maxillary molar in absence of the second molar. Therefore, this study was made to evaluate the effect of bilateral distalization of upper first molars in a group of patients after extraction of maxillary second Molars using infra zygomatic mini implants.
Detailed description
The appliances available for distalization used to be mainly extraoral distalizing appliances which depended entirely on patient cooperation and compliance. Even after the emergence of intra-oral distalizing appliances they had adverse dentoalveolar effect such as anchorage loss and flaring of the upper anterior teeth. Thus, this study was made in order to evaluate the efficiency of our proposed appliance in the treatment of Class II patients while avoiding the adverse effects mentioned above.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intra-oral Distalizing Appliance | Experimental | Device: Intra-Oral Distalizing DeviceTwo infra zygomatic mini-implants will be placed Bands will be cemented to upper first molars. The inner bow (1.2mm) is a modified version of the inner part of a conventional face bow. Two hooks were soldered onto the inner bow distal to the lateral incisor teeth regions, and U loop at 1st premolar region, and bends acting as mesial stop will be bent in front of the maxillary first molars. Orthodontic force 300 mg per side Will be delivered by Niti closed coil spring which is attached from infra zygomatic mini screw to the hook soldered to the wire framework. |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Female Patients with cervical vertebra maturation index (CVMI) 5 \& 6.
- From quarter unit to 3\4-unit class II molar relationship.
- An overjet of an average 6mm.
- Full Set of permanent dentition except for the maxillary second molar.
- Favorable path of eruption for the maxillary third molar.
Key exclusion criteria (5 listed)
- Medically compromised Patients.
- Patients under long term medications.
- Patients having sever periodontal disease.
- CVMI 3 or less
- Full unit class II cases
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 |
|---|---|---|
| Intra-Oral Distalizing DeviceThe inner bow (1.2mm) is a modified version of the inner part of a conventional face bow. Two hooks were soldered onto the inner bow distal to the lateral incisor teeth regions, and U loop at 1st premolar region, and bends acting as mesial stop will be bent in front of the maxillary first molars. The anterior component of the inner bow is 3 mm free from the labial surface of anterior teeth | Device | Intra-oral Distalizing Appliance |
Primary outcome
linear distalization of maxillary 1st molar.
Time frame: Up until Class I Molar Relation (a maximum of 8 months regardless)
Efficiency of the proposed appliance to induce distalization of the upper 1st molar measured on Scanned dental casts as well as cone-beam computed tomography (CBCT) in millimetres.
Rate of maxillary 1st molar Distalization in mm/ month.
Time frame: Up until Class I Molar Relation (a maximum of 8 months regardless)
Efficiency of the proposed appliance to induce distalization of the upper 1st molar measured on Scanned dental casts with a monthly follow up in millimetres.
2 secondary outcomes
Changes in Intermolar width in mm.
Time frame: Up until Class I Molar Relation (a maximum of 8 months regardless)
Changes of Molar inclination in degrees.
Time frame: Up until Class I Molar Relation (a maximum of 8 months regardless)
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 17 Feb 2023.
- Individual participant dataSharing planned: Yes. All collected individual participant data (IPD)
Related trials for Class II Malocclusion
Enrolling by invitation
Discision as Acceleration Method in Canine Retraction in Orthodontics With Aligner and Fixed Appliances in Young Adults a Split Mouth Study
Bimaxillary Protrusion, Class II Div 1 Malocclusion
Recruiting
Maxillary Arch Distalization With Infrazygomatic Crest Miniscrews for Class II Malocclusion
Class II Malocclusion
Recruiting
Comparing 3D-Printed and Milled Titanium Plates in Jaw Surgery (Le Fort I): Accuracy and Operative Time
Malocclusion, Angle Class II, Malocclusion, Angle Class III
Recruiting
Treatment of Mild Class II Malocclusion in Adult Patients With Clear Aligners Versus Fixed Multibracket Therapy
Malocclusion, Class II Malocclusion
Recruiting
Patient-Reported Outcomes for Different Orthodontic Thermoplastics Used in Clear Aligners
Malocclusion of Anterior Teeth, Malocclusion in Children
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.
Yehia Mostafa, Professr and Chairman study director
Future University in Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intra-Oral Distalizing Device in people with Class II Malocclusion, run by Future University in Egypt 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 5 inclusion and 5 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 17 Feb 2023. 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?
linear distalization of maxillary 1st molar. (time frame: Up until Class I Molar Relation (a maximum of 8 months regardless)). 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 17 Feb 2023.