Acceleration of Orthodontic Tooth Movement

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Mild to Moderate Anterior Mandibular Segment Crowdind

Intervention / Treatment
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* Drug: Dihydroxycholecalciferols
* Other: dimethyl sulfoxide
* Other: serum


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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
Interventional Model Description: Parallel Assignment, A randomized, controlled, parallel, double-blind clinical study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Six participants were bonded with 0.022 × 0.028 inch slot brackets (Ortho Smile) using pre-adjusted edgewise appliance with 0.022 MBT prescriptions. Local periodontal injection of 1,25 DHC at weekly interval (3 times). The gingival fluid volume will measured befor and after 1-1.5 hours after first injection. the same is done visit at the second and third visits. Pain during injection and treatment will be assessed using the FLACC scale and face scale | Drug: Dihydroxycholecalciferols<br>* Injection of Dihydroxycholecalciferols solution in the periodontal ligament for lower anterior segment teeth.<br>|
| Experimental: Group 2<br>Six participants were bonded with 0.022 × 0.028 inch slot brackets (Ortho Smile) using pre-adjusted edgewise appliance with 0.022 MBT prescriptions. Local periodontal injection of dimethylsulfoxide at weekly interval (3 times). The gingival fluid volume will measured befor and after 1-1.5 hours after first injection. the same is done visit at the second and third visits. Pain during injection and treatment will be assessed using the FLACC scale and face scale. | Other: dimethyl sulfoxide<br>* Injection of dimethyl sulfoxide in the periodontal ligament for lower anterior segment teeth.<br>|
| Experimental: Group 3<br>Six participants were bonded with 0.022 × 0.028 inch slot brackets (Ortho Smile) using pre-adjusted edgewise appliance with 0.022 MBT prescriptions. ocal periodontal injection of serum at weekly interval (3 times). The gingival fluid volume will measured once. Pain during treatment will be assessed using the FLACC scale and face scale. | Other: serum<br>* Injection of serum in the periodontal ligament for lower anterior segment teeth.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Outcome Measure was the overall time needed to complete leveling and aligning (OLAT) the mandible dental arch | 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Second Outcome Measure was leveling and alignment improvement percentage (LAIP) of the Mandible teeth throughout the leveling and alignment stage. | 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. | 6 months | 
| VAS scale | to measure patient pain or discomfort | 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Orthodontic, Calcitriol, Local injection, OTM Randomized controlled trial, Vitamin D,.