Genes Associated With Bone Metabolism in the Saliva During Orthodontic Treatment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

24 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-10-12

Study Completion Date

2026-02-28

Brief Summary

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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

Detailed Description

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Conditions

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Gene Expression Profiling Orthodentic Appliances

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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PCR

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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. -

Minimum Eligible Age

15 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Shehab Ahmed Hamad

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hawler teaching hospital

Erbil, Ervil, Iraq

Site Status

Countries

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Iraq

References

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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.

Reference Type BACKGROUND

PMID: 38028229 (View on PubMed)

Other Identifiers

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2561

Identifier Type: -

Identifier Source: org_study_id