Genes Associated With Bone Metabolism in the Saliva During Orthodontic Treatment

December 18, 2025 updated by: Shehab Ahmed Hamad, Kurdistan Higher Council of Medical Specialties

Expression of Genes Related to Bone Metabolism in Saliva of Patients During Early Fixed Orthodontic Treatment: a Prospective Clinical Study

Understanding the biological events during fixed orthodontic treatment is essential for optimizing treatment strategies, predicting patient response, and minimizing adverse effects. Most studies on bone remodeling have used invasive sampling methods such as tissue biopsies or serum collection; these methods cannot be used for routine clinical monitoring. Saliva is a simple medium that can reflect changes in local periodontal and bone conditions, it is also non-invasive and cheap. There is little evidence about the temporal expression of genes related to bone metabolism (RANKL, OPG, ALP, TRAP, RUNX2) in saliva during orthodontic therapy. This study will help advance the understanding of biological responses during orthodontic tooth movement and explore whether saliva can be an appropriate diagnostic medium for monitoring bone remodeling in orthodontic patients

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

24

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iraq
    • Ervil
      • Erbil, Ervil, Iraq, 44001
        • Hawler Teaching Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Twenty-four patients (mean age 18.5 ± 3.2 years) who were receiving fixed orthodontic care were enrolled in this investigation.

Description

Inclusion criteria:

1.15 to 25 years of age 2.moderate crowding (3-6 mm) 3.generally good health with no systemic conditions that could influence bone metabolism 4. no recent use of medications known to affect bone metabolism (such as bisphosphonates and corticosteroids) or any other NSAIDs.

Exclusion criteria:

  1. periodontal disease
  2. smoking or any form of tobacco use
  3. pregnancy or lactation
  4. prior orthodontic treatment
  5. craniofacial syndromes
  6. The use of antibiotics within 3 months before the study. -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
salivary genes of bone metabolism
Time Frame: 4 weeks
Change in salivary gene expression levels of key bone-metabolism genes (e.g., RANKL, OPG, RUNX2, ALPL, BMP2) from baseline (T0) to subsequent timepoints during fixed orthodontic treatment, measured as ΔCt or fold-change (ΔΔCt) using qRT-PCR.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kurdistan Higher Council of Medical Specialties

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 12, 2025

Primary Completion (Estimated)

February 1, 2026

Study Completion (Estimated)

February 1, 2026

Study Registration Dates

First Submitted

December 7, 2025

First Submitted That Met QC Criteria

December 18, 2025

First Posted (Actual)

December 26, 2025

Study Record Updates

Last Update Posted (Actual)

December 26, 2025

Last Update Submitted That Met QC Criteria

December 18, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 2561

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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