Tooth CrowdingNCT06416189
Teeth Decrowding With and Without Fixed Appliances
A study testing Fixed appliances in people with Tooth Crowding, run by Samer Mheissen at 1 site in Jordan.
Trial summary
In orthodontics, the teeth tend to move to the extraction space. This tooth movement becomes of larger importance when there is a crowding. During the COVID lockdown period, It was noted that some cases have a significant improvement and almost all the crowding was relieved without appliance activation. Read more about this study
- Who is it for?
- Ages 13 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Crowding
- What is being tested?
- Fixed appliances
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteJordan
- Study dates
- 2 Feb 2024to 31 Dec 2024
- 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 13 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients with permanent dentition between age group of 13 - 30 years.
- Maxillary or mandibular crowding >4.1mm and requiring extraction of maxillary first premolars or mandibular first premolars. The crowding will be measured using a caliper one cast models.
- Fully erupted teeth from 1st molar to the 1st molar.
- Patients with periodontally sound dentition.
- Patients with good general health. No previous history of extraction or orthodontic tooth movement.
Who cannot join
- Cases requiring orthognathic surgery.
- History of systemic and medical illness.
- Contraindication of extraction.
- Previous history of orthodontic treatment.
- Poor oral hygiene.
- Nickel allergy.
Trial locations and contacts
1 site in 1 country.
Haris Khan, PhD contact
Jordan1 site, 1 recruiting
- Recruiting
Medical Services
Amman, 00962
Hanan Habarneh, DDS, +962 7 7233 6009, hna987@hotmail.com
About this study
Official title: The Decrowding Rate Post Premolar Extraction With and Without Fixed Appliance: Randomized Controlled Trial
In orthodontics, the teeth tend to move to the extraction space. This tooth movement becomes of larger importance when there is a crowding. During the COVID lockdown period, It was noted that some cases have a significant improvement and almost all the crowding was relieved without appliance activation.
Read the detailed description
In this randomized controlled trial, a sufficient number of patients would be randomly assigned into two groups; one with braces and one without fixed braces.
- Conditions
- Tooth Crowding
- Being tested
- Fixed appliances
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fixed appliancesDevice
MBT Brackets 0.022 inch
| Study group | Role | What they receive |
|---|---|---|
| Braces | Active comparator | Fixed appliance would be bonded post teeth extraction (premolars). subsequently, leveling and alignment using sequence of archwires would be followed. The measurements would be done using models each month. Receives: Device: Fixed appliances |
| Without braces | No intervention | Extraction of premolars and only observing the case over time. The measurements would be done using models each month. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anterior teeth alignment every 4 weeks at each time point.
The cumulative before extraction and space closure for 4 months (mean difference before and after)..
Measured: 6 months
Secondary outcomes (2)
Molar anchorage loss at each time point.
The anchorage loss of molars will be measured over time using the models.
Measured: 6 months
Gingival invagination
this will be measured by visual inspection intraorally.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start2 Feb 2024
- Primary completion30 Aug 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth CrowdingStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups; one with fixed braces and one without fixed braces.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samer Mheissen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samer Mheissen, Samer Mheissen
- Investigators
- Samer Mheissen, DDS, Principal investigator, Private Practice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06416189
- Sponsor's protocol ID
- Ortho-0001
- Status last verified
- May 2024
- First submitted
- 26 Jan 2024
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Decrowding Rate Post Premolar Extraction With and Without Fixed Appliance: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06416189
- Acronym / sponsor ID
- Ortho-0001
- Conditions
- Tooth Crowding
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Samer MheissenUniversity, hospital or other
- Study start
- 2 Feb 2024 (actual)
- Primary completion
- 30 Aug 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 16 May 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.
In orthodontics, the teeth tend to move to the extraction space. This tooth movement becomes of larger importance when there is a crowding. During the COVID lockdown period, It was noted that some cases have a significant improvement and almost all the crowding was relieved without appliance activation.
Detailed description
In this randomized controlled trial, a sufficient number of patients would be randomly assigned into two groups; one with braces and one without fixed braces.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Two groups; one with fixed braces and one without fixed braces.
| Arm | Type | Receives |
|---|---|---|
| Braces | Active comparator | Device: Fixed appliancesFixed appliance would be bonded post teeth extraction (premolars). subsequently, leveling and alignment using sequence of archwires would be followed. The measurements would be done using models each month. |
| Without braces | No intervention | –Extraction of premolars and only observing the case over time. The measurements would be done using models each month. |
Who may qualify
- Ages
- 13 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Patients with permanent dentition between age group of 13 - 30 years.
- Maxillary or mandibular crowding >4.1mm and requiring extraction of maxillary first premolars or mandibular first premolars. The crowding will be measured using a caliper one cast models.
- Fully erupted teeth from 1st molar to the 1st molar.
- Patients with periodontally sound dentition.
- Patients with good general health. No previous history of extraction or orthodontic tooth movement.
Key exclusion criteria (6 listed)
- Cases requiring orthognathic surgery.
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 |
|---|---|---|
| Fixed appliancesMBT Brackets 0.022 inch | Device | Braces |
Primary outcome
Anterior teeth alignment every 4 weeks at each time point.
Time frame: 6 months
The cumulative before extraction and space closure for 4 months (mean difference before and after)..
2 secondary outcomes
Molar anchorage loss at each time point.
Time frame: 6 months
Gingival invagination
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Individual participant dataSharing planned: Yes
Related trials for Tooth Crowding
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Bracketless Orthodontic Treatment (3D-BOT) Versus Conventional Fixed Braces for Mild-to-Moderate Lower Front Tooth Crowding in Adults
Mild-to-Moderate Mandibular Anterior Crowding
Recruiting
Evaluating the Efficacy of Micro-Osteoperforations Technique on the Orthodontic Tooth Movement Acceleration in Moderate Mandibular Anterior Crowding Cases Treated With Clear Aligners
Crowding of Anterior Mandibular Teeth
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Exploration of the Utility of Dental-dedicated MRI for Dentistry
Dental Crowding, Dental Occlusion, Traumatic
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Efficiency, Efficacy, Periodontal & Occlusal Outcomes for Aligners Versus Fixed Orthodontic Appliances in Crowded Incisor Treatment
Crowding of Anterior Mandibular Teeth
Not yet recruiting
Effect of Different Adhesive Systems on White Spot Lesions During Fixed Orthodontic Treatment
Malaligned Teeth, Crowding of Teeth
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.
Haris Khan, PhD contact
Samer Mheissen, DDS principal investigator
Private Practice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fixed appliances in people with Tooth Crowding, run by Samer Mheissen at 1 site in Jordan.
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 6 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 16 May 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 Jordan. 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?
Contact Samer Mheissen, orthodontics (00962795710426, mheissen@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anterior teeth alignment every 4 weeks at each time point. (time frame: 6 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 16 May 2024.