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Acceleration of Orthodontic Tooth Movement

NCT ID: NCT05560919

Last Updated: 2022-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-20

Study Completion Date

2022-06-25

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.

Conditions

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Mild to Moderate Anterior Mandibular Segment Crowdind

Keywords

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Orthodontic, Calcitriol, Local injection, OTM Randomized controlled trial, Vitamin D,.

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel Assignment, A randomized, controlled, parallel, double-blind clinical study
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
The participant will be blinded, the drug administrator will be blinded too, and the investigator who will give the treatment and explain the pain scale to the participant and ask him\\her to point to the face that fits the degree of his pain that associated with the drug administration will also be blinded.

Study Groups

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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

Group Type EXPERIMENTAL

Dihydroxycholecalciferols

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

dimethyl sulfoxide

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

serum

Intervention Type OTHER

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

Interventions

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Dihydroxycholecalciferols

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

Intervention Type DRUG

dimethyl sulfoxide

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

Intervention Type OTHER

serum

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

Intervention Type OTHER

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.
Minimum Eligible Age

15 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tishreen University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Tishreen University - Faculty of dentistry

Latakia, , Syria

Site Status

Countries

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Syria

Other Identifiers

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Tishreen U _Orthodontics

Identifier Type: -

Identifier Source: org_study_id