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Completed

NCT Number: NCT05560919

Acceleration of Orthodontic Tooth Movement

EVALUATION OF EFFICACY OF LOCALLY INJECTED Vitamin D3 (calcitriol or 1.25 dihidroxicolecalciferol) IN ACCELERATING ORTHODONTIC MOVEMENT Design: A randomized, controlled, crossover, double-blind clinical study including Eighteen adult , aged 15-25 years old.

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Key information

Conditions

Mild to Moderate Anterior Mandibular Segment Crowdind

Age range

15 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Tishreen University - Faculty of dentistry

Latakia, Syria

About this study

The rate of orthodontic tooth movement depends on two general factors: the forces used in order to cause orthodontic tooth movement and respectively the individual (biological) response of the body to these forces.

There are many methods for accelerating orthodontic tooth movement. but, every method has its disadvantages, such as pain and root absorption. Locally injected of vitamin d3 was proposed to accelerates tooth movement with minimal disadvantages, but there aren't enough clinical studies to prove this claim.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Mild to moderate crowding of mandible teeth. In accordance with LITTLE'S IRREGULARITY INDEX
  • Healthy patient
  • No previous orthodontic treatment
  • Vital teeth with periodental tissue without root absorption,

Exclusion criteria

  • Previous history of orthodontic or orthopedic treatment.
  • Presence of craniofacial anomalies.
  • Presence of any signs and symptoms of gingival and periodontal diseases.
  • Presence of significant medical history (including drug allergy).
  • Pregnant and lactating women.

Treatment and study plan

Dihydroxycholecalciferols

Drug

Injection of Dihydroxycholecalciferols solution in the periodontal ligament for lower anterior segment teeth.

dimethyl sulfoxide

Other

Injection of dimethyl sulfoxide in the periodontal ligament for lower anterior segment teeth.

Serum

Other

Injection of serum in the periodontal ligament for lower anterior segment teeth.

Primary outcomes

  1. Primary Outcome Measure was the overall time needed to complete leveling and aligning (OLAT) the mandible dental arch

    Time frame: 6 months

    To calculate outcome measures, a mandible alginate impression was taken to make study casts at three time points:

    before insertion of the first archwire (T0), after 1 month of treatment commencement (T1), and at the end of the leveling and alignment stage (T2), represented by final archwire insertion.

    LII was used to measure the change in tooth alignment on the casts. It involved measuring the horizontal linear distance among adjacent contact points of the six anterior teeth. The sum of these five measurements gave the value of the index. LII was measured using a digital caliper to the nearest 0.01 mm by the corresponding author.

    OLAT was calculated by the number of days between T0 and T2.

Secondary outcomes

  1. Second Outcome Measure was leveling and alignment improvement percentage (LAIP) of the Mandible teeth throughout the leveling and alignment stage.

    Time frame: 6 months

    OLAT was calculated by the number of days between T0 and T2. LAIP was calculated by dividing the amount of change in the LII value at a specific time point (T1, T2 ; calculated by subtracting the LII value at T1, T2 from the LII value at T0) by Lll value at T0. OLAT was calculated by the number of days between T0 and T2.

    LAIP was calculated by dividing the amount of change in the LII value at a specific time point (T1, T2 ; calculated by subtracting the LII value at T1, T2 from the LII value at T0) by Lll value at T0.

  2. VAS scale

    Time frame: 3 weeks

    to measure patient pain or discomfort

Sponsors and collaborators

Lead sponsor

Latakia University

Other

Registry information

Official study title

Evaluation of Clinical Efficacy of Locally Injected Vitamin D3 (Calcitriol or 1,25 Dihidroxicolecalciferol) in Accelerating Orthodontic Tooth Movement (A Randomized Controlled Trial)

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 30, 2022
Registry last updated
Sep 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.