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Efficacy of Injectable Vitamin C on Accelerating Canine Movement: A Clinical Study (mesotherapy)

Primary Purpose

Palatally Impacted Canines

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

vitamin C

About this trial

This is an interventional treatment trial for Palatally Impacted Canines focused on measuring vitamin C, palatally impacted canines, intraepidermal injection

Eligibility Criteria

15 Years - 40 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

medically free
patient with good to fair oral hygiene (gingivitis may be included)
both sexes were included
unilateral palatally positioned permenant canines
absence of previous orthodontic treatment
absence of supernumerary teeth, odontoms, cysts, traumatic injuries
the α angle within grade II to III

Exclusion Criteria:

systemic diseases especially diabetes and bone diseases
pregnant and lactating mothers
Local causes (smoking, mouth breathing, local trauma and periodontitis).

Sites / Locations

Faculty of Oral and Dental Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

vitamin C injection

orthodontic traction

Arm Description

orthodontic traction with vitamin C injection

orthodontic traction without vitamin C injection

Outcomes

Primary Outcome Measures

rate of tooth movement

the achieved movement in millimeters in one year

Secondary Outcome Measures

level of alveolar bone

the level of the interproximal and facial alveolar bone after orthodontic treatment with or without injection

Full Information

NCT ID

NCT03260829

First Posted

January 11, 2017

Last Updated

August 25, 2017

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT03260829

Brief Title

Efficacy of Injectable Vitamin C on Accelerating Canine Movement: A Clinical Study

Acronym

mesotherapy

Official Title

Evaluation of the Effect of Local Injected Vitamin C on Accelerating the Orthodontic Movement of Maxillary Canine Impaction: A Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Completed

Study Start Date

January 2014 (undefined)

Primary Completion Date

January 2015 (Actual)

Study Completion Date

February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

efficacy of the injectable vitamin C to reduce the time of canine traction

Detailed Description

Objective. The purpose of this study is to investigate the role and efficiency of the locally injected vitamin C in the enhancement of the palatally impacted canine movement. Design. Twelve adult patients with unilateral palatally impacted canines were included in this study. The enrolled patients were randomly allocated into the study groups; control group; orthodontic traction and he test group: orthodontic traction enhanced by intraepidermic vitamin C injection. The study duration was 12 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Palatally Impacted Canines

Keywords

vitamin C, palatally impacted canines, intraepidermal injection

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Non-Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

vitamin C injection

Arm Type

Active Comparator

Arm Description

orthodontic traction with vitamin C injection

Arm Title

orthodontic traction

Arm Type

Placebo Comparator

Arm Description

orthodontic traction without vitamin C injection

Intervention Type

Drug

Intervention Name(s)

vitamin C

Other Intervention Name(s)

ascorbic acid

Intervention Description

25 IU of vitamin C injected intraepidermally for 6-8 visits till eruption achieved

Primary Outcome Measure Information:

Title

rate of tooth movement

Description

the achieved movement in millimeters in one year

Time Frame

12 months

Secondary Outcome Measure Information:

Title

level of alveolar bone

Description

the level of the interproximal and facial alveolar bone after orthodontic treatment with or without injection

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: medically free patient with good to fair oral hygiene (gingivitis may be included) both sexes were included unilateral palatally positioned permenant canines absence of previous orthodontic treatment absence of supernumerary teeth, odontoms, cysts, traumatic injuries the α angle within grade II to III Exclusion Criteria: systemic diseases especially diabetes and bone diseases pregnant and lactating mothers Local causes (smoking, mouth breathing, local trauma and periodontitis).

Facility Information:

Facility Name

Faculty of Oral and Dental Medicine

City

Gizah

State/Province

Giza

ZIP/Postal Code

11311

Country

Egypt

12. IPD Sharing Statement

Citations:

PubMed Identifier

Citation

Makar AB, McMartin KE, Palese M, Tephly TR. Formate assay in body fluids: application in methanol poisoning. Biochem Med. 1975 Jun;13(2):117-26. doi: 10.1016/0006-2944(75)90147-7. No abstract available.

Results Reference

result

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Efficacy of Injectable Vitamin C on Accelerating Canine Movement: A Clinical Study

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