Genes Associated With Bone Metabolism in the Saliva During Orthodontic Treatment

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: Gene Expression Profiling; Orthodentic Appliances
• Intervention / Treatment: Diagnostic test: PCR

• Study Type: Observational
• Enrollment (Actual): 24

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
salivary genes of bone metabolism	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

• Sponsor: Kurdistan Higher Council of Medical Specialties

Publications and helpful links

General Publications

• Nugraha AP, Ernawati DS, Narmada IB, Bramantoro T, Riawan W, Situmorang PC, Nam HY. RANK-RANKL-OPG expression after gingival mesenchymal stem cell hypoxia preconditioned application in an orthodontic tooth movement animal model. J Oral Biol Craniofac Res. 2023 Nov-Dec;13(6):781-790. doi: 10.1016/j.jobcr.2023.10.009. Epub 2023 Nov 8.

Study record dates

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