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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07303647

Enrollment

Registered

2025-12-26

Start date

2025-10-12

Completion date

2026-02-28

Last updated

2025-12-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gene Expression Profiling, Orthodentic Appliances

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

Interventions

DIAGNOSTIC_TESTPCR

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.

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

15 Years to 25 Years

Healthy volunteers

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. -

Design outcomes

Primary

Measure	Time frame	Description
salivary genes of bone metabolism	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.

Countries

Iraq

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026