Tooth Position AnomaliesNCT04837781
The Effect of Vitamin D3 on the Rate of Orthodontic Tooth Movement
A study testing Micro-osteoperforation in people with Tooth Position Anomalies, run by University of Baghdad at 1 site in Iraq.
Trial summary
The aim of this study is to evaluate the effect of vitamin D3 deficiency on the rate of orthodontic tooth movement in both conventional and accelerated orthodontic. Assessing both lower anterior teeth alignment and the rate of maxillary canine retraction. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Position Anomalies
- What is being tested?
- Micro-osteoperforation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteIraq
- Study dates
- 23 Feb 2019to 8 Mar 2021
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age ranged from 18 to 30 years, from both sex.
- Healthy general medical condition, healthy periodontal condition.
- Malocclusion that requires extraction of the maxillary first premolars, followed by canine retraction, with moderate lower incisor crowding (Little's irregularity index 3-6mm).
- Normal shape and structure of maxillary canine, with no history of filling or root canal treatment and normal shape and structure of maxillary first molar.
Who cannot join
- Pregnant women.
- Patient with renal or liver disease.
- Patient taking corticosteroid or anticonvulsant drugs.
- Patient with thyroid or parathyroid problems.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Vitamin D3 on the Rate of Orthodontic Tooth Movement (Conventional and Accelerated): Clinical Trial
The aim of this study is to evaluate the effect of vitamin D3 deficiency on the rate of orthodontic tooth movement in both conventional and accelerated orthodontic. Assessing both lower anterior teeth alignment and the rate of maxillary canine retraction.
Read the detailed description
To evaluate the effect of vitamin D deficiency on the rate of orthodontic tooth movement in both conventional and accelerated orthodontic, additionally find the effect of vitamin D deficiency on molar anchorage loss, canine rotation, lower incisor crowding alignment time, pain experienced by the patient during OTM and rate of orthodontically induce apical root resorption.
- Conditions
- Tooth Position Anomalies
- Being tested
- Micro-osteoperforation
- Keywords
- Orthodontic, tooth movement, acceleration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micro-osteoperforationProcedure or surgery
Also called MOP
Micro-osteoperforation Mini-implant facilitated micro-osteoperforation (MOPs) were placed in the experimental side before canine retraction. Three MOPs were placed distal to canine on experimental sides in all group.
| Study group | Role | What they receive |
|---|---|---|
| Normal vitamin D | Experimental | Include patients with normal vitamin D level (above 30ng/ml). Vitamin D level will be measured at the beginning of treatment if there is deficiency then the patient refer to specialized physician to be supplied with vitamin D supplement to optimized the level to normal then start orthodontic treatment Receives: Procedure: Micro-osteoperforation |
| Vitamin D deficiency | Experimental | Include patients with unknown vitamin D level until time of canine retraction where we measure level if deficiency exist (below 30ng/ml) then the patient will be referred to specialized physician to be supplied with vitamin D supplement. Receives: Procedure: Micro-osteoperforation |
| Control | Experimental | includes patients with unknown vitamin D level until the completion of canine retraction where we measure level. If deficiency exists (below 30ng/ml) then we will refer the patient to specialized physician to be supplied with vitamin D supplement Receives: Procedure: Micro-osteoperforation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Canine retraction rate
Maxillary study model will be 3D scan using optical 3D scanner(Smart Optic,Germany) then measurement done on digital model using 3D program( DentalCad,Galway,3.0,2021),to measure distance from tip of canine to 3rd palatal raguea on both side
Measured: 4 weeks
Canine retraction rate
Maxillary study model will be 3D scan using optical 3D scanner(Smart Optic,Germany) then measurement done on digital model using 3D program( DentalCad,Galway,3.0,2021),to measure distance from tip of canine to 3rd palatal raguea on both side
Measured: 8 weeks
Canine retraction rate
Maxillary study model will be 3D scan using optical 3D scanner(Smart Optic,Germany) then measurement done on digital model using 3D program( DentalCad,Galway,3.0,2021),to measure distance from tip of canine to 3rd palatal raguea on both side
Measured: 12 weeks
Canine retraction rate
Maxillary study model will be 3D scan using optical 3D scanner(Smart Optic,Germany) then measurement done on digital model using 3D program( DentalCad,Galway,3.0,2021),to measure distance from tip of canine to 3rd palatal raguea on both side
Measured: 16 weeks
Secondary outcomes (5)
Alignment efficiency
3D scanned study models were used to measure the amount of crowding in the mandibular anterior teeth using 3Dprogram (DentalCad,Galway,3.0,2021). If Little's irregularity index is less than 1mm and alignment improvement not above 0.5 mm between two successive visits, then treatment is regarded as finished.
Measured: 4 weeks
Alignment efficiency
3D scanned study models were used to measure the amount of crowding in the mandibular anterior teeth using 3Dprogram (DentalCad,Galway,3.0,2021). If Little's irregularity index is less than 1mm and alignment improvement not above 0.5 mm between two successive visits, then treatment is regarded as finished.
Measured: 8 weeks
Alignment efficiency
3D scanned study models were used to measure the amount of crowding in the mandibular anterior teeth using 3Dprogram (DentalCad,Galway,3.0,2021). If Little's irregularity index is less than 1mm and alignment improvement not above 0.5 mm between two successive visits, then treatment is regarded as finished.
Measured: 12 weeks
Root resorption
The amount of root resorption was measured at the start of treatment and after 12 weeks, the length of the root was recoded at these time intervals. Radiographic films were positioned using a customized sensor holder for the lower anterior teeth with a 7cm film-cone distance using long cone paralleling technique. The radiographs were made at 70kV and 8mA DC with an exposure of 0.25 seconds.
Measured: 12 weeks
pain perception
Evaluations of pain/discomfort was made in the evening on a daily basis over the first 7 days after bonding using a 10- point visual analog scale (VAS) of 10cm length. The highest pain level experienced should be reported by each patient.
The recording sheet was received by all the patients on the day of bonding, it included seven visual analog scales (one for each day) and the patients were given oral instructions on how to finish the VAS by marking the point on the line which supposed to represent the maximum pain that they felt per day, with 0 refers to "no pain" and 10 refers to "intolerable pain". Patients were reminded daily by a phone call or a text message to mark the recording sheet and to bring it on their next appointment
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start23 Feb 2019
- Primary completion2 Feb 2021
- Study completion8 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tooth Position AnomaliesStudies of the same condition, open and under way.
- More trials run by University of BaghdadThe 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
- Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mushriq F. Abid, University of Baghdad
- Investigators
- Mushriq Abid, MSc, PhD, Principal investigator, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04837781
- Sponsor's protocol ID
- 178420
- Status last verified
- Apr 2021
- First submitted
- 6 Apr 2021
- Last updated
- 12 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Al-Attar A, Abid M. The Effect of Vitamin D3 on the Alignment of Mandibular Anterior Teeth: A Randomized Controlled Clinical Trial. Int J Dent. 2022 Feb 14;2022:6555883. doi: 10.1155/2022/6555883. eCollection 2022.
PubMed 35198025
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Vitamin D3 on the Rate of Orthodontic Tooth Movement (Conventional and Accelerated): Clinical Trial
- ClinicalTrials.gov ID
- NCT04837781
- Acronym / sponsor ID
- 178420
- Conditions
- Tooth Position Anomalies
- Keywords
- Orthodontic, tooth movement, acceleration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 23 Feb 2019 (actual)
- Primary completion
- 2 Feb 2021 (actual)
- Study completion
- 8 Mar 2021 (actual)
- First posted
- 8 Apr 2021 (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 aim of this study is to evaluate the effect of vitamin D3 deficiency on the rate of orthodontic tooth movement in both conventional and accelerated orthodontic. Assessing both lower anterior teeth alignment and the rate of maxillary canine retraction.
Detailed description
To evaluate the effect of vitamin D deficiency on the rate of orthodontic tooth movement in both conventional and accelerated orthodontic, additionally find the effect of vitamin D deficiency on molar anchorage loss, canine rotation, lower incisor crowding alignment time, pain experienced by the patient during OTM and rate of orthodontically induce apical root resorption.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal vitamin D | Experimental | Procedure: Micro-osteoperforationInclude patients with normal vitamin D level (above 30ng/ml). Vitamin D level will be measured at the beginning of treatment if there is deficiency then the patient refer to specialized physician to be supplied with vitamin D supplement to optimized the level to normal then start orthodontic treatment |
| Vitamin D deficiency | Experimental | Procedure: Micro-osteoperforationInclude patients with unknown vitamin D level until time of canine retraction where we measure level if deficiency exist (below 30ng/ml) then the patient will be referred to specialized physician to be supplied with vitamin D supplement. |
| Control | Experimental | Procedure: Micro-osteoperforationincludes patients with unknown vitamin D level until the completion of canine retraction where we measure level. If deficiency exists (below 30ng/ml) then we will refer the patient to specialized physician to be supplied with vitamin D supplement |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age ranged from 18 to 30 years, from both sex.
- Healthy general medical condition, healthy periodontal condition.
- Malocclusion that requires extraction of the maxillary first premolars, followed by canine retraction, with moderate lower incisor crowding (Little's irregularity index 3-6mm).
- Normal shape and structure of maxillary canine, with no history of filling or root canal treatment and normal shape and structure of maxillary first molar.
Key exclusion criteria (4 listed)
- Pregnant women.
- Patient with renal or liver disease.
- Patient taking corticosteroid or anticonvulsant drugs.
- Patient with thyroid or parathyroid problems.
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 |
|---|---|---|
| Micro-osteoperforationAlso: MOPMicro-osteoperforation Mini-implant facilitated micro-osteoperforation (MOPs) were placed in the experimental side before canine retraction. Three MOPs were placed distal to canine on experimental sides in all group. | Procedure or surgery | Control, Normal vitamin D, Vitamin D deficiency |
Primary outcome
Canine retraction rate
Time frame: 4 weeks
Maxillary study model will be 3D scan using optical 3D scanner(Smart Optic,Germany) then measurement done on digital model using 3D program( DentalCad,Galway,3.0,2021),to measure distance from tip of canine to 3rd palatal raguea on both side
Canine retraction rate
Time frame: 8 weeks
Maxillary study model will be 3D scan using optical 3D scanner(Smart Optic,Germany) then measurement done on digital model using 3D program( DentalCad,Galway,3.0,2021),to measure distance from tip of canine to 3rd palatal raguea on both side
Canine retraction rate
Time frame: 12 weeks
Maxillary study model will be 3D scan using optical 3D scanner(Smart Optic,Germany) then measurement done on digital model using 3D program( DentalCad,Galway,3.0,2021),to measure distance from tip of canine to 3rd palatal raguea on both side
Canine retraction rate
Time frame: 16 weeks
Maxillary study model will be 3D scan using optical 3D scanner(Smart Optic,Germany) then measurement done on digital model using 3D program( DentalCad,Galway,3.0,2021),to measure distance from tip of canine to 3rd palatal raguea on both side
5 secondary outcomes
Alignment efficiency
Time frame: 4 weeks
Alignment efficiency
Time frame: 8 weeks
Alignment efficiency
Time frame: 12 weeks
Root resorption
Time frame: 12 weeks
pain perception
Time frame: 7 days
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 12 Apr 2021.
- Derived from this study: PubMed 35198025Al-Attar A, Abid M. The Effect of Vitamin D3 on the Alignment of Mandibular Anterior Teeth: A Randomized Controlled Clinical Trial. Int J Dent. 2022 Feb 14;2022:6555883. doi: 10.1155/2022/6555883. eCollection 2022.
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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.
Mushriq Abid, MSc, PhD principal investigator
University of Baghdad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Micro-osteoperforation in people with Tooth Position Anomalies, run by University of Baghdad at 1 site in Iraq.
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 4 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 12 Apr 2021. 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 Iraq. 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?
Canine retraction rate (time frame: 4 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04837781, which also lists 1 linked publication.
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 12 Apr 2021.