Efficacy of Injectable Vitamin C on Accelerating Canine M... | NCT03260829

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

NCT03260829

Sponsor

Cairo University

Status

Completed

Last Update Posted

Aug 29, 2017Actual

Enrollment

12Actual

Phase

Not Applicable

Conditions

Palatally Impacted Canines

Interventions

vitamin C

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
no conflict of interest	Other Identifier

Status Module

Record Verification Date

Aug 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2014

Primary Completion Date

Jan 2015Actual

Completion Date

Feb 2015Actual

First Submitted Date

Jan 11, 2017

First Submission Date that Met QC Criteria

Aug 23, 2017

First Posted Date

Aug 24, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 25, 2017

Last Update Posted Date

Aug 29, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
vitamin C	Drug	25 IU of vitamin C injected intraepidermally for 6-8 visits till eruption achieved	orthodontic traction vitamin C injection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
rate of tooth movement	the achieved movement in millimeters in one year	12 months

Secondary Outcomes

Measure	Description	Time Frame
level of alveolar bone	the level of the interproximal and facial alveolar bone after orthodontic treatment with or without injection	12 months

Other Outcomes

Not provided

Eligibility Module

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).

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

40 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Oral and Dental Medicine		Giza	Giza Governorate	11311	Egypt

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
1	Result	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.

ID	Term
D013400	Sugar Acids
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals