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OpenTrials
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NCT Number: NCT07303647

Genes Associated With Bone Metabolism in the Saliva During Orthodontic Treatment

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Gene Expression Profiling Orthodentic Appliances

Age range

15 year–25 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hawler teaching hospital

Erbil, Ervil, 44001, Iraq

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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. -

Treatment and study plan

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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Kurdistan Higher Council of Medical Specialties

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 26, 2025
Registry last updated
Dec 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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