Acceleration of Orthodontic Tooth Movement

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

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.

Study Overview

• Status: Completed
• Conditions: Mild to Moderate Anterior Mandibular Segment Crowdind
• Intervention / Treatment: Drug: Dihydroxycholecalciferols; Other: dimethyl sulfoxide; Other: serum

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Syrian Arab Republic
  • Latakia, Syrian Arab Republic
    • Tishreen University - faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 25 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1; 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; Injection of Dihydroxycholecalciferols solution in the periodontal ligament for lower anterior segment teeth.
Experimental: Group 2; 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; Injection of dimethyl sulfoxide in the periodontal ligament for lower anterior segment teeth.
Experimental: Group 3; 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; Injection of serum in the periodontal ligament for lower anterior segment teeth.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Tishreen University

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2021
• Primary Completion (Actual): April 30, 2022
• Study Completion (Actual): June 25, 2022

Study Registration Dates

• First Submitted: September 26, 2022
• First Submitted That Met QC Criteria: September 26, 2022
• First Posted (Actual): September 30, 2022

Study Record Updates

• Last Update Posted (Actual): September 30, 2022
• Last Update Submitted That Met QC Criteria: September 26, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Orthodontic, Calcitriol, Local injection, OTM Randomized controlled trial, Vitamin D,.
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Micronutrients; Vitamins; Bone Density Conservation Agents; Antioxidants; Free Radical Scavengers; Cryoprotective Agents; Dimethyl Sulfoxide; Dihydroxycholecalciferols
• Other Study ID Numbers: Tishreen U _Orthodontics

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Study Protocol, Informed Consent Form
• IPD Sharing Time Frame: 8 months
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

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