Palatally Impacted CaninesmesotherapyNCT03260829
Efficacy of Injectable Vitamin C on Accelerating Canine Movement: A Clinical Study
A study testing vitamin C in people with Palatally Impacted Canines, run by Cairo University at 1 site in Egypt.
Trial summary
efficacy of the injectable vitamin C to reduce the time of canine traction Read more about this study
- Who is it for?
- Ages 15 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Palatally Impacted Canines
- What is being tested?
- vitamin C
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2014to Feb 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- systemic diseases especially diabetes and bone diseases
- pregnant and lactating mothers
- Local causes (smoking, mouth breathing, local trauma and periodontitis).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effect of Local Injected Vitamin C on Accelerating the Orthodontic Movement of Maxillary Canine Impaction: A Clinical Trial
efficacy of the injectable vitamin C to reduce the time of canine traction
Read the 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.
- Conditions
- Palatally Impacted Canines
- Being tested
- vitamin C
- Keywords
- vitamin C, palatally impacted canines, intraepidermal injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitamin CDrug
Also called ascorbic acid
25 IU of vitamin C injected intraepidermally for 6-8 visits till eruption achieved
| Study group | Role | What they receive |
|---|---|---|
| vitamin C injection | Active comparator | orthodontic traction with vitamin C injection Receives: Drug: vitamin C |
| orthodontic traction | Placebo comparator | orthodontic traction without vitamin C injection Receives: Drug: vitamin C |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of tooth movement
the achieved movement in millimeters in one year
Measured: 12 months
Secondary outcomes (1)
level of alveolar bone
the level of the interproximal and facial alveolar bone after orthodontic treatment with or without injection
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2017
- Study startJan 2014
- Primary completionJan 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Palatally Impacted CaninesStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, nermin mohammed ahmed yussif, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03260829
- Sponsor's protocol ID
- oral and dental medicine
- Other IDs
- no conflict of interest
- Acronym
- mesotherapy
- Status last verified
- Aug 2017
- First submitted
- 11 Jan 2017
- Last updated
- 29 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 1
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Local Injected Vitamin C on Accelerating the Orthodontic Movement of Maxillary Canine Impaction: A Clinical Trial
- ClinicalTrials.gov ID
- NCT03260829
- Acronym / sponsor ID
- mesotherapy / oral and dental medicine
- Conditions
- Palatally Impacted Canines
- Keywords
- vitamin C, palatally impacted canines, intraepidermal injection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 24 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vitamin C injection | Active comparator | Drug: vitamin Corthodontic traction with vitamin C injection |
| orthodontic traction | Placebo comparator | Drug: vitamin Corthodontic traction without vitamin C injection |
Who may qualify
- Ages
- 15 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- systemic diseases especially diabetes and bone diseases
- pregnant and lactating mothers
- Local causes (smoking, mouth breathing, local trauma and periodontitis).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vitamin CAlso: ascorbic acid25 IU of vitamin C injected intraepidermally for 6-8 visits till eruption achieved | Drug | orthodontic traction, vitamin C injection |
Primary outcome
rate of tooth movement
Time frame: 12 months
the achieved movement in millimeters in one year
1 secondary outcome
level of alveolar bone
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2017.
- Results publication: PubMed 1Makar 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.
Related trials for Palatally Impacted Canines
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vitamin C in people with Palatally Impacted Canines, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of tooth movement (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03260829, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2017.