THE EFFECT OF VITAMIN C ON POST-ORTHODONTIC TREATMENT RELAPSE

NCT ID: NCT06146296

Last Updated: 2023-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-01

Study Completion Date

2024-06-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Orthodontic Relapse

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intra-epidermal Vitamin C injection

Group Type EXPERIMENTAL

Local Vitamin C injection

Intervention Type BIOLOGICAL

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 Vit-C supplement

Group Type ACTIVE_COMPARATOR

Oral Vitamin C supplement

Intervention Type BIOLOGICAL

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

Control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Local 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.

Intervention Type BIOLOGICAL

Oral Vitamin C supplement

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

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Nourhan M.Aly

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Nourhan M.Aly

Assistant Lecturer of Dental Public Health

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Samar M Adel, PhD

Role: PRINCIPAL_INVESTIGATOR

Alexandria University

Farah Y Eid, PhD

Role: PRINCIPAL_INVESTIGATOR

Alexandria University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Faculty of Dentistry, Alexandria University

Alexandria, , Egypt

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Samar M Adel, PhD

Role: CONTACT

1099911526 ext. +20

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Samar M Adel, PhD

Role: primary

109 9911526 ext. +20

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

#10/23

Identifier Type: -

Identifier Source: org_study_id