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THE EFFECT OF VITAMIN C ON POST-ORTHODONTIC TREATMENT RELAPSE

THE EFFECT OF VITAMIN C ON POST-ORTHODONTIC TREATMENT RELAPSE: A RANDOMIZED CONTROLLED CLINICAL TRIAL

Status
UNKNOWN
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06146296
Enrollment
36
Registered
2023-11-24
Start date
2023-11-01
Completion date
2024-06-01
Last updated
2023-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Orthodontic Relapse

Brief 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

Interventions

BIOLOGICALLocal Vitamin C injection

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.

Patients will be prescribed a daily oral (systemic) Vit-C supplement to be taken over the follow up period.

Sponsors

Nourhan M.Aly
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
19 Years to 25 Years
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Measurement of post-orthodontic relapseup to 8 monthsAlginate 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 levelsup to 8 monthsSalivary 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.

Countries

Egypt

Contacts

Primary ContactSamar M Adel, PhD
orthosamar@gmail.com1099911526

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026