Malocclusion, Angle Class IINCT06240923
"Three Dimensional Assessment of Maxillary Molars Following Distalization Using Two Different Approaches"
A study testing Maxillary molars distalization in people with Malocclusion, Angle Class II, run by Ain Shams University at 1 site in Egypt.
Trial summary
The goal of this controlled clinical trial is to compare the effects of two distalization methods supported by inter-radicular mini-screw for maxillary molars distalization in 20 adult patients with skeletal class I or moderate skeletal class II malocclusion, dental class II molar relationship, and full permanent… Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Malocclusion, Angle Class II
- What is being tested?
- Maxillary molars distalization
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Jan 2017to 23 Jun 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 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- All subjects are free from any dental anomalies as well as periodontal and systemic diseases that may influence orthodontic treatment.
- Adult patients with age ranging from 18 to 25 years.
- Full permanent dentition with exclusion of third molars.
- Both first and second maxillary molars are in occlusion.
- Skeletal class I, mild or moderate skeletal class II malocclusion.
- Full cusp or end to end class II molar relationship.
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- Mild to moderate crowding in the upper dental arch and / or increased overjet.
- Normal or horizontal growth pattern.
- Non-extraction treatment plan.
Who cannot join
- Previous orthodontic treatment.
- Treatment planning requiring orthognathic surgery.
- Severe molar rotation.
- Poor oral hygiene.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this controlled clinical trial is to compare the effects of two distalization methods supported by inter-radicular mini-screw for maxillary molars distalization in 20 adult patients with skeletal class I or moderate skeletal class II malocclusion, dental class II molar relationship, and full permanent dentition. The participants were randomly selected according to inclusion / exclusion criteria from the outpatient clinic of the Department of Orthodontics and Dentofacial Orthopedics, Faculty of dentistry, Ain Shams University, Cairo, Egypt. Selectees age was ranging from 18 to 25 years old.
An informed consent has been signed by each patient before his / her enrollment in this study, where the aim , methodology, and possible complications were been clearly described in details. This research has been thoroughly reviewed by the Research Ethics Committee of the Faculty of dentistry, Ain Shams University.
Read the detailed description
This study is a two-arm, parallel group, prospective randomized clinical trial with the allocation ratio of 1:1. The Consolidated Standards of Reporting Trials (CONSORT statement) were used as a guide for this study.
After reviewing the study protocol, the ethical committee at the Faculty of Dentistry, Ain-Shams University approved the study.
Before treatment was carried out, a detailed written Arabic consent was signed by all the subjects of both groups after full explanation of the aim of the study and the procedures.
This prospective clinical study was conducted on a total of 24 maxillary first molars.
No financial competing interests: This study was part of a Masters' degree in Orthodontics, Faculty of Dentistry, Ain-Shams University.
No financial conflicts of interest were declared. The study was self- funded by the principal investigator.
A sample size of 24 distalizing sites was selected and divided into two groups twelve each:
Group 1: Single coil spring. Group 2: Double coil spring.
- Conditions
- Malocclusion, Angle Class II
- Being tested
- Maxillary molars distalization
- Keywords
- Dental malocclusion
- Medical subject headings
- Malocclusion, Angle Class II, Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maxillary molars distalizationDevice
Also called Posterior displacement of maxillary molars
Maxillary molars distalization by using a nickel titanium open coil spring as an posterior displacement device.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Single coil spring | Experimental | A single open coil spring was inserted between the maxillary second premolar and the maxillary first molar with a distalizing force 300 gm. Receives: Device: Maxillary molars distalization |
| Group 2: Double coil spring | Experimental | Two open coil springs were inserted. The first coil spring was inserted between the maxillary second premolar and the maxillary first molar with a distalization force 300gm, and the second coil spring was inserted between the maxillary first and maxillary second molar with a distalization force 200 gm. Receives: Device: Maxillary molars distalization |
What is being measured
The primary outcome is the main question the study is designed to answer.
The amount of maxillary molars distalization
Primary outcome of this study is to determine the amount of maxillary molars linear distal movement distance measured in millimeters.
Measured: 8-10 months
The type of maxillary molars distalization
Molar tipping measured by the degree of the angle of tipping.
Measured: 8-10 months
Secondary outcomes (1)
Loss of anchorage
Anterior linear displacement of the premolars measured in millimeters.
Measured: 8-10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start2 Jan 2017
- Primary completion16 Mar 2022
- Study completion23 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malocclusion, Angle Class IIStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Model description
- A sample size of 24 maxillary dental distalizing sites were selected and divided into two groups twelve in each: Group 1: Single coil spring. Group 2: Double coil spring.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gihan Mohamed Anwar Mohamed Khattab, Ain Shams University
- Investigators
- Noha I Abdelrahman, Assoc. Prof., Study director, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06240923
- Sponsor's protocol ID
- ORD 16-6M
- Status last verified
- Feb 2024
- First submitted
- 12 Dec 2023
- Last updated
- 5 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF)
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Three Dimensional Assessment of Maxillary Molars Following Distalization Using Two Different Approaches"
- ClinicalTrials.gov ID
- NCT06240923
- Acronym / sponsor ID
- ORD 16-6M
- Conditions
- Malocclusion, Angle Class II
- Keywords
- Dental malocclusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 2 Jan 2017 (actual)
- Primary completion
- 16 Mar 2022 (actual)
- Study completion
- 23 Jun 2022 (actual)
- First posted
- 5 Feb 2024 (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 goal of this controlled clinical trial is to compare the effects of two distalization methods supported by inter-radicular mini-screw for maxillary molars distalization in 20 adult patients with skeletal class I or moderate skeletal class II malocclusion, dental class II molar relationship, and full permanent dentition. The participants were randomly selected according to inclusion / exclusion criteria from the outpatient clinic of the Department of Orthodontics and Dentofacial Orthopedics, Faculty of dentistry, Ain Shams University, Cairo, Egypt. Selectees age was ranging from 18 to 25 years old.
An informed consent has been signed by each patient before his / her enrollment in this study, where the aim , methodology, and possible complications were been clearly described in details. This research has been thoroughly reviewed by the Research Ethics Committee of the Faculty of dentistry, Ain Shams University.
Detailed description
This study is a two-arm, parallel group, prospective randomized clinical trial with the allocation ratio of 1:1. The Consolidated Standards of Reporting Trials (CONSORT statement) were used as a guide for this study.
After reviewing the study protocol, the ethical committee at the Faculty of Dentistry, Ain-Shams University approved the study.
Before treatment was carried out, a detailed written Arabic consent was signed by all the subjects of both groups after full explanation of the aim of the study and the procedures.
This prospective clinical study was conducted on a total of 24 maxillary first molars.
No financial competing interests: This study was part of a Masters' degree in Orthodontics, Faculty of Dentistry, Ain-Shams University.
No financial conflicts of interest were declared. The study was self- funded by the principal investigator.
A sample size of 24 distalizing sites was selected and divided into two groups twelve each:
Group 1: Single coil spring. Group 2: Double coil spring.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A sample size of 24 maxillary dental distalizing sites were selected and divided into two groups twelve in each: Group 1: Single coil spring. Group 2: Double coil spring.
| Arm | Type | Receives |
|---|---|---|
| Group 1: Single coil spring | Experimental | Device: Maxillary molars distalizationA single open coil spring was inserted between the maxillary second premolar and the maxillary first molar with a distalizing force 300 gm. |
| Group 2: Double coil spring | Experimental | Device: Maxillary molars distalizationTwo open coil springs were inserted. The first coil spring was inserted between the maxillary second premolar and the maxillary first molar with a distalization force 300gm, and the second coil spring was inserted between the maxillary first and maxillary second molar with a distalization force 200 gm. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- All subjects are free from any dental anomalies as well as periodontal and systemic diseases that may influence orthodontic treatment.
- Adult patients with age ranging from 18 to 25 years.
- Full permanent dentition with exclusion of third molars.
- Both first and second maxillary molars are in occlusion.
- Skeletal class I, mild or moderate skeletal class II malocclusion.
Key exclusion criteria (4 listed)
- Previous orthodontic treatment.
- Treatment planning requiring orthognathic surgery.
- Severe molar rotation.
- Poor oral hygiene.
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 |
|---|---|---|
| Maxillary molars distalizationAlso: Posterior displacement of maxillary molarsMaxillary molars distalization by using a nickel titanium open coil spring as an posterior displacement device. | Device | Group 1: Single coil spring, Group 2: Double coil spring |
Primary outcome
The amount of maxillary molars distalization
Time frame: 8-10 months
Primary outcome of this study is to determine the amount of maxillary molars linear distal movement distance measured in millimeters.
The type of maxillary molars distalization
Time frame: 8-10 months
Molar tipping measured by the degree of the angle of tipping.
1 secondary outcome
Loss of anchorage
Time frame: 8-10 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 5 Feb 2024.
- Individual participant dataSharing planned: No. Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF)
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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.
Noha I Abdelrahman, Assoc. Prof. study director
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maxillary molars distalization in people with Malocclusion, Angle Class II, run by Ain Shams 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 9 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 5 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?
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?
The amount of maxillary molars distalization (time frame: 8-10 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 5 Feb 2024.