The Effect of Vitamin D3 on the Rate of Orthodontic Tooth Movement

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effect of Vitamin D3 on the Rate of Orthodontic Tooth Movement (Conventional and Accelerated): Clinical Trial

Conditions
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Tooth Position Anomalies

Intervention / Treatment
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* Procedure: Micro-osteoperforation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Pregnant women. Patient with renal or liver disease. Patient taking corticosteroid or anticonvulsant drugs. Patient with thyroid or parathyroid problems.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Normal vitamin D<br>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 | Procedure: Micro-osteoperforation<br>* 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.<br>* Other names: MOP;|
| Experimental: Vitamin D deficiency<br>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. | Procedure: Micro-osteoperforation<br>* 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.<br>* Other names: MOP;|
| Experimental: Control<br>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 | Procedure: Micro-osteoperforation<br>* 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.<br>* Other names: MOP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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 | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Orthodontic, tooth movement, acceleration