NCT06146296

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2023

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2023

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

November 17, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 24, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

November 24, 2023

Status Verified

November 1, 2023

Enrollment Period

7 months

First QC Date

November 17, 2023

Last Update Submit

November 17, 2023

Conditions

Orthodontic Relapse

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    up to 8 months

Study Arms (3)

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

Interventions

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.

Intra-epidermal Vitamin C injection
Oral Vitamin C supplementBIOLOGICAL

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

Oral Vit-C supplement

Eligibility Criteria

Age19 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Alexandria University

Alexandria, Egypt

RECRUITING

Study Officials

  • Samar M Adel, PhD

    Alexandria University

    PRINCIPAL INVESTIGATOR

  • Farah Y Eid, PhD

    Alexandria University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Samar M Adel, PhD

CONTACT

1099911526orthosamar@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Lecturer of Dental Public Health

Study Record Dates

First Submitted

November 17, 2023

First Posted

November 24, 2023

Study Start

November 1, 2023

Primary Completion

June 1, 2024

Study Completion

June 1, 2024

Last Updated

November 24, 2023

Record last verified: 2023-11

Locations

EG(1)