Orthodontic Tooth MovementNCT06032702
Effect of 3 Week vs 6 Week Orthodontic Appointment Intervals on Teeth Alignment
A study testing tooth alignment in people with Orthodontic Tooth Movement and Tooth Alignment, run by Bkahtawar Amin Medical and Dental College Multan at 1 site in Pakistan.
Trial summary
Effect of 3 week vs 6 week orthodontic appointment intervals on teeth alignment in patients with moderate to severe dental crowding: a randomized clinical trial. There is still inconclusive evidence about the orthodontics treatment duration and interappointment interval. Read more about this study
- Who is it for?
- Ages 16 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Orthodontic Tooth Movement, Tooth Alignment
- What is being tested?
- tooth alignment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jun 2023to 1 Dec 2023
- 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 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients aged 16-30
- Little's irregularity index from 5mm to 12mm
- Healthy periodontium
- No systemic disease
- Patients giving consent for inclusion
Who cannot join
- Little's irregularity index less than 5mm and more than 12mm
- Blocked out incisors needing push coil
- Ankylosed teeth
- Active periodontal disease
- Systemic bone disease
- Non-compliant patients
- Patients with frequent breakages
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Bakhtawar Amin Medical And Dental College
Multan, Punjab Province, 66000
Waqar Jeelani, BDS,FCPS, MOrth-Edin UK, 00923457936578, wjeelani@gmail.com
Maheen Ahmed, BDS,FCPS, MOrth-Edin UK, 00923002799443, a_maheen01@hotmail.com
About this study
Official title: Effect of 3 Week vs 6 Week Orthodontic Appointment Intervals on Teeth Alignment in Patients With Moderate to Severe Dental Crowding: a Randomized Clinical Trial
Effect of 3 week vs 6 week orthodontic appointment intervals on teeth alignment in patients with moderate to severe dental crowding: a randomized clinical trial.
There is still inconclusive evidence about the orthodontics treatment duration and interappointment interval.
Read the detailed description
Patients with moderate to severe crowding will be divided randomly into two groups (Group A and Group B). Group A includes patients with an interval of 3 weeks between their appointments while Group B includes the patients with an interval of 6 weeks between their appointments.
- To determine the mean changes in the tooth irregularity index of a patient with mild to moderate crowding activated every 3rd week
- To determine the mean changes in the tooth irregularity index of a patient with mild to moderate crowding activated every 6th week
- To compare the difference between the two modalities in percentage
- Conditions
- Orthodontic Tooth Movement, Tooth Alignment
- Being tested
- tooth alignment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tooth alignmentProcedure or surgery
Alignment will be assessed by Little's Irregularity Index
| Study group | Role | What they receive |
|---|---|---|
| 3 week interval | Experimental | 3 week orthodontic interappointment interval Receives: Procedure: tooth alignment |
| 6 week interval | Experimental | 6 week orthodontic interappointment interval Receives: Procedure: tooth alignment |
What is being measured
The primary outcome is the main question the study is designed to answer.
alignment efficiency and interappointment interval
Changes in Little's Irregularity Index between arm 1 and arm 2 and comparison of both interventions.
Measured: Time frame for measurement of (Little's Irregularity Index) was every 6th week over a period of 6 months, giving a total of 5 measurements
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start1 Jun 2023
- Primary completion1 Nov 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthodontic Tooth MovementStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bkahtawar Amin Medical and Dental College Multan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06032702
- Sponsor's protocol ID
- BAMDC 0001
- Status last verified
- Sep 2023
- First submitted
- 5 Sep 2023
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of 3 Week vs 6 Week Orthodontic Appointment Intervals on Teeth Alignment in Patients With Moderate to Severe Dental Crowding: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06032702
- Acronym / sponsor ID
- BAMDC 0001
- Conditions
- Orthodontic Tooth Movement, Tooth Alignment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Bkahtawar Amin Medical and Dental College MultanUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Nov 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 13 Sep 2023 (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.
Effect of 3 week vs 6 week orthodontic appointment intervals on teeth alignment in patients with moderate to severe dental crowding: a randomized clinical trial.
There is still inconclusive evidence about the orthodontics treatment duration and interappointment interval.
Detailed description
Patients with moderate to severe crowding will be divided randomly into two groups (Group A and Group B). Group A includes patients with an interval of 3 weeks between their appointments while Group B includes the patients with an interval of 6 weeks between their appointments.
- To determine the mean changes in the tooth irregularity index of a patient with mild to moderate crowding activated every 3rd week
- To determine the mean changes in the tooth irregularity index of a patient with mild to moderate crowding activated every 6th week
- To compare the difference between the two modalities in percentage
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3 week interval | Experimental | Procedure: tooth alignment3 week orthodontic interappointment interval |
| 6 week interval | Experimental | Procedure: tooth alignment6 week orthodontic interappointment interval |
Who may qualify
- Ages
- 16 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Patients aged 16-30
- Little's irregularity index from 5mm to 12mm
- Healthy periodontium
- No systemic disease
- Patients giving consent for inclusion
Key exclusion criteria (7 listed)
- Little's irregularity index less than 5mm and more than 12mm
- Blocked out incisors needing push coil
- Ankylosed teeth
- Active periodontal disease
- Systemic bone disease
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 alignmentAlignment will be assessed by Little's Irregularity Index | Procedure or surgery | 3 week interval, 6 week interval |
Primary outcome
alignment efficiency and interappointment interval
Time frame: Time frame for measurement of (Little's Irregularity Index) was every 6th week over a period of 6 months, giving a total of 5 measurements
Changes in Little's Irregularity Index between arm 1 and arm 2 and comparison of both interventions.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Individual participant dataSharing planned: Undecided. Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tooth alignment in people with Orthodontic Tooth Movement and Tooth Alignment, run by Bkahtawar Amin Medical and Dental College Multan at 1 site in Pakistan.
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 7 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 13 Sep 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 Pakistan. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
alignment efficiency and interappointment interval (time frame: Time frame for measurement of (Little's Irregularity Index) was every 6th week over a period of 6 months, giving a total of 5 measurements). 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 13 Sep 2023.