NCT03260829

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

January 11, 2017

Completed
8 months until next milestone

First Posted

Study publicly available on registry

August 24, 2017

Completed
Last Updated

August 29, 2017

Status Verified

August 1, 2017

Enrollment Period

1 year

First QC Date

January 11, 2017

Last Update Submit

August 25, 2017

Conditions

Palatally Impacted Canines

Keywords

vitamin Cpalatally impacted caninesintraepidermal injection

Outcome Measures

Primary Outcomes (1)

  • rate of tooth movement

    the achieved movement in millimeters in one year

    12 months

Secondary Outcomes (1)

  • level of alveolar bone

    12 months

Study Arms (2)

vitamin C injection

ACTIVE COMPARATOR

orthodontic traction with vitamin C injection

Drug: vitamin C

orthodontic traction

PLACEBO COMPARATOR

orthodontic traction without vitamin C injection

Drug: vitamin C

Interventions

vitamin CDRUG

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

Also known as: ascorbic acid
orthodontic tractionvitamin C injection

Eligibility Criteria

Age15 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Oral and Dental Medicine

Giza, Giza Governorate, 11311, Egypt

Location

Related Publications (1)

  • 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.

    PMID: 1RESULT

MeSH Terms

Interventions

Ascorbic Acid

Intervention Hierarchy (Ancestors)

Sugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsCarbohydrates

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer

Study Record Dates

First Submitted

January 11, 2017

First Posted

August 24, 2017

Study Start

January 1, 2014

Primary Completion

January 1, 2015

Study Completion

February 1, 2015

Last Updated

August 29, 2017

Record last verified: 2017-08

Locations

EG(1)