Orthodontic RelapsePhase 2/3NCT06146296
THE EFFECT OF VITAMIN C ON POST-ORTHODONTIC TREATMENT RELAPSE
A Phase 2/3 study testing Local Vitamin C injection and Oral Vitamin C supplement in people with Orthodontic Relapse, run by Nourhan M.Aly at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate and compare the effect of locally injected and orally administered (systemic) Vitamin C on post-orthodontic treatment relapse Read more about this study
- Who is it for?
- Ages 19 to 25 years
- Conditions the study is for
- Orthodontic Relapse
- What is being tested?
- Local Vitamin C injection and Oral Vitamin C supplement
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2023to 1 Jun 2024
- Phase
- Phase 2/3
- 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 19 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients who were indicated for non-extraction orthodontic treatment.
- Adult patients with finished orthodontic treatment, using fixed appliance therapy.
- Patients with good oral hygiene, and a healthy periodontal condition.
Who cannot join
- Patients who received sectional fixed appliance therapy.
- Patients with hypodontia requiring tooth replacement in the retainer, as a temporary measure.
- Patients requiring fixed bonded retainers.
- Pregnant and lactating women.
- Patients with hereditary hemochromatosis.
- Cancer patients, receiving chemotherapy.
- Patients with chronic diseases such as diabetes, or those receiving drugs such as corticosteroids, both of which that may affect tooth movement.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry, Alexandria University
Alexandria
Samar M Adel, PhD, 109 9911526 ext. +20, orthosamar@gmail.com
About this study
Official title: THE EFFECT OF VITAMIN C ON POST-ORTHODONTIC TREATMENT RELAPSE: A RANDOMIZED CONTROLLED CLINICAL TRIAL
The aim of this study is to evaluate and compare the effect of locally injected and orally administered (systemic) Vitamin C on post-orthodontic treatment relapse
- Conditions
- Orthodontic Relapse
- Being tested
- Local Vitamin C injection, Oral Vitamin C supplement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local Vitamin C injectionBiological
An injection of 1-1.5 ml of L-ascorbic acid, locally introduced in relation to the keratinized gingival tissues, with extension to the whole target region successively. The injected area will be massaged for equal distribution of the injected vitamin. Injections will be performed on the first day of retainer delivery (T0), after 1 month (T1), after 3 months (T2), and after 6 months (T3). Hence, a total of 4 local Vit-C injections will be performed over the study period.
Oral Vitamin C supplementBiological
Patients will be prescribed a daily oral (systemic) Vit-C supplement to be taken over the follow up period.
| Study group | Role | What they receive |
|---|---|---|
| Intra-epidermal Vitamin C injection | Experimental | Not described Receives: Biological: Local Vitamin C injection |
| Oral Vit-C supplement | Active comparator | Not described Receives: Biological: Oral Vitamin C supplement |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of post-orthodontic relapse
Alginate impressions will be taken, and dental models will then be scanned using Sirona inEos X5 CAD/CAM lab scanner, producing 3D digital images of the dental models in the form of stereolithographic (STL) files, which will be subsequently imported into a computer software. Little's Irregularity Index (LII) will be employed for the measurement and the quantitative evaluation of the lower anterior segment alignment. The horizontal linear displacement of the anatomic contact points of each mandibular incisor from the adjacent anatomic point is measured, and the 5 displacements are then summed together. The summed value represents the degree of anterior irregularity as follows: 0 = Perfect alignment. 1-3 = Minimal irregularity. 4-6 = Moderate irregularity. 7-9 = Severe irregularity. 10 = Very severe irregularity.
Measured: up to 8 months
Analysis of salivary alkaline phosphatase levels
Salivary samples will be collected and measured using chemical analysis. Rise in salivary alkaline phosphatase levels reflects inflammation and destruction of healthy tissues suggesting it as a clinical biomarker. The normal level of alkaline phosphatase is 20-140IU/L (international unit per liter) in adults.
Measured: up to 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2023
- Study start1 Nov 2023
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthodontic RelapseStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nourhan M.Aly
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nourhan M.Aly, University of Alexandria
- Investigators
- Samar M Adel, PhD, Principal investigator, Alexandria UniversityFarah Y Eid, PhD, Principal investigator, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06146296
- Sponsor's protocol ID
- #10/23
- Status last verified
- Nov 2023
- First submitted
- 17 Nov 2023
- Last updated
- 24 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECT OF VITAMIN C ON POST-ORTHODONTIC TREATMENT RELAPSE: A RANDOMIZED CONTROLLED CLINICAL TRIAL
- ClinicalTrials.gov ID
- NCT06146296
- Acronym / sponsor ID
- #10/23
- Conditions
- Orthodontic Relapse
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Nourhan M.AlyUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 24 Nov 2023 (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.
The aim of this study is to evaluate and compare the effect of locally injected and orally administered (systemic) Vitamin C on post-orthodontic treatment relapse
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intra-epidermal Vitamin C injection | Experimental | Biological: Local Vitamin C injection |
| Oral Vit-C supplement | Active comparator | Biological: Oral Vitamin C supplement |
| Control group | No intervention | – |
Who may qualify
- Ages
- 19 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients who were indicated for non-extraction orthodontic treatment.
- Adult patients with finished orthodontic treatment, using fixed appliance therapy.
- Patients with good oral hygiene, and a healthy periodontal condition.
Key exclusion criteria (7 listed)
- Patients who received sectional fixed appliance therapy.
- Patients with hypodontia requiring tooth replacement in the retainer, as a temporary measure.
- Patients requiring fixed bonded retainers.
- Pregnant and lactating women.
- Patients with hereditary hemochromatosis.
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 |
|---|---|---|
| Local Vitamin C injectionAn injection of 1-1.5 ml of L-ascorbic acid, locally introduced in relation to the keratinized gingival tissues, with extension to the whole target region successively. The injected area will be massaged for equal distribution of the injected vitamin. Injections will be performed on the first day of retainer delivery (T0), after 1 month (T1), after 3 months (T2), and after 6 months (T3). Hence, a total of 4 local Vit-C injections will be performed over the study period. | Biological | Intra-epidermal Vitamin C injection |
| Oral Vitamin C supplementPatients will be prescribed a daily oral (systemic) Vit-C supplement to be taken over the follow up period. | Biological | Oral Vit-C supplement |
Primary outcome
Measurement of post-orthodontic relapse
Time frame: up to 8 months
Alginate impressions will be taken, and dental models will then be scanned using Sirona inEos X5 CAD/CAM lab scanner, producing 3D digital images of the dental models in the form of stereolithographic (STL) files, which will be subsequently imported into a computer software. Little's Irregularity Index (LII) will be employed for the measurement and the quantitative evaluation of the lower anterior segment alignment. The horizontal linear displacement of the anatomic contact points of each mandibular incisor from the adjacent anatomic point is measured, and the 5 displacements are then summed together. The summed value represents the degree of anterior irregularity as follows: 0 = Perfect alignment. 1-3 = Minimal irregularity. 4-6 = Moderate irregularity. 7-9 = Severe irregularity. 10 = Very severe irregularity.
Analysis of salivary alkaline phosphatase levels
Time frame: up to 8 months
Salivary samples will be collected and measured using chemical analysis. Rise in salivary alkaline phosphatase levels reflects inflammation and destruction of healthy tissues suggesting it as a clinical biomarker. The normal level of alkaline phosphatase is 20-140IU/L (international unit per liter) in adults.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2023.
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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.
Samar M Adel, PhD principal investigator
Alexandria University
Farah Y Eid, PhD principal investigator
Alexandria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Local Vitamin C injection and Oral Vitamin C supplement in people with Orthodontic Relapse, run by Nourhan M.Aly 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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 24 Nov 2023. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Samar M Adel, PhD (1099911526 ext. +20, orthosamar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of post-orthodontic relapse (time frame: up to 8 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Nov 2023.