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

NCT04837781 | Completed

• 1 other identifier: 178420
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tooth Position Anomalies

Keywords

Orthodontic, tooth movement, acceleration

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• Alignment efficiency

  4 weeks

• Alignment efficiency

  8 weeks

• Alignment efficiency

  12 weeks

• Root resorption

  12 weeks

• pain perception

  7 days

Study Arms (3)

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

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.

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

Procedure: Micro-osteoperforation

Interventions

Micro-osteoperforation PROCEDURE

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.

Also known as: MOP

Control; Normal vitamin D; Vitamin D deficiency

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Pregnant women.
• Patient with renal or liver disease.
• Patient taking corticosteroid or anticonvulsant drugs.
• Patient with thyroid or parathyroid problems.

Sponsors & Collaborators

• University of Baghdad: lead

Study Sites (1)

College of Dentisry-University of Baghdad

Baghdad, Al-Rusafa, Iraq

Location

Related Publications (1)

• 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.

  PMID: 35198025 DERIVED

Study Officials

• Mushriq Abid, MSc, PhD

  University of Baghdad

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Blinding to treatment allocation was possible only for the investigator and data analyst because the clinicians could know the intervention as osteo-perforation can be obviously seen clearly. Masking the intervention for the participants were not possible because micro-osteoperforation is a surgical procedure. All the trial documents were labeled with the study ID number, which was used for participant identification and data collection without unmasking the allocation group. This allowed the investigator to complete data collection and measurements blindly.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 6, 2021
• First Posted: April 8, 2021
• Study Start: February 23, 2019
• Primary Completion: February 2, 2021
• Study Completion: March 8, 2021
• Last Updated: April 12, 2021

Record last verified: 2021-04

Locations

IR (1)