Genes Associated With Bone Metabolism in the Saliva During Orthodontic Treatment

NCT07303647 | Active Not Recruiting DMC

• 1 other identifier: 2561
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Gene Expression Profiling; Orthodentic Appliances

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

PCR DIAGNOSTIC_TEST

Unstimulated whole saliva collection SOP (time of day, fasting, avoid toothbrushing immediately prior). RNA stabilization and extraction (saliva RNA kits). cDNA synthesis and quantitative RT-PCR (or RNA-seq if budget allows). Housekeeping genes for normalization (e.g., GAPDH, ACTB - validate stability in saliva). Analysis method: ΔΔCt → fold change.

Eligibility Criteria

• Age: 15 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Kurdistan Higher Council of Medical Specialties: lead

Study Sites (1)

Hawler teaching hospital

Erbil, Ervil, 44001, Iraq

Location

Related Publications (1)

• 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.

  PMID: 38028229 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: December 7, 2025
• First Posted: December 26, 2025
• Study Start: October 12, 2025
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: December 26, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)