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

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.

Study Overview

• Status: Completed
• Conditions: Tooth Position Anomalies
• Intervention / Treatment: Procedure: Micro-osteoperforation

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 Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iraq
  • Al-Rusafa
    • Baghdad, Al-Rusafa, Iraq
      • College of Dentisry-University of Baghdad

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age ranged from 18 to 30 years, from both sex.
2. Healthy general medical condition, healthy periodontal condition.
3. Malocclusion that requires extraction of the maxillary first premolars, followed by canine retraction, with moderate lower incisor crowding (Little's irregularity index 3-6mm).
4. 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:

1. Pregnant women.
2. Patient with renal or liver disease.
3. Patient taking corticosteroid or anticonvulsant drugs.
4. Patient with thyroid or parathyroid problems.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Normal vitamin D; 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; 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.; Other Names: MOP
EXPERIMENTAL: Vitamin D deficiency; 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; 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.; Other Names: MOP
EXPERIMENTAL: Control; 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; 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.; Other Names: MOP

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Baghdad
• Investigators: Principal Investigator: Mushriq Abid, MSc, PhD, University of Baghdad

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 23, 2019
• Primary Completion (ACTUAL): February 2, 2021
• Study Completion (ACTUAL): March 8, 2021

Study Registration Dates

• First Submitted: April 6, 2021
• First Submitted That Met QC Criteria: April 6, 2021
• First Posted (ACTUAL): April 8, 2021

Study Record Updates

• Last Update Posted (ACTUAL): April 12, 2021
• Last Update Submitted That Met QC Criteria: April 7, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Orthodontic, tooth movement, acceleration
• Other Study ID Numbers: 178420

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No