THE EFFECT OF VITAMIN C ON POST-ORTHODONTIC TREATMENT RELAPSE

Sponsor
Nourhan M.Aly (Other)
Overall Status
Recruiting
CT.gov ID
NCT06146296
Collaborator
(none)
36
1
3
7
5.1

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Biological: Local Vitamin C injection
  • Biological: Oral Vitamin C supplement
Phase 2/Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
36 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Supportive Care
Official Title:
THE EFFECT OF VITAMIN C ON POST-ORTHODONTIC TREATMENT RELAPSE: A RANDOMIZED CONTROLLED CLINICAL TRIAL
Actual Study Start Date :
Nov 1, 2023
Anticipated Primary Completion Date :
Jun 1, 2024
Anticipated Study Completion Date :
Jun 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intra-epidermal Vitamin C injection

Biological: 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.

Active Comparator: Oral Vit-C supplement

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

No Intervention: Control group

Outcome Measures

Primary Outcome Measures

  1. Measurement of post-orthodontic relapse [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.

  2. Analysis of salivary alkaline phosphatase levels [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years to 25 Years
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of Dentistry, Alexandria University Alexandria Egypt

Sponsors and Collaborators

  • Nourhan M.Aly

Investigators

  • Principal Investigator: Samar M Adel, PhD, Alexandria University
  • Principal Investigator: Farah Y Eid, PhD, Alexandria University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nourhan M.Aly, Assistant Lecturer of Dental Public Health, University of Alexandria
ClinicalTrials.gov Identifier:
NCT06146296
Other Study ID Numbers:
  • #10/23
First Posted:
Nov 24, 2023
Last Update Posted:
Nov 24, 2023
Last Verified:
Nov 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 24, 2023