Gene Expression ProfilingNCT07303647
Genes Associated With Bone Metabolism in the Saliva During Orthodontic Treatment
An observational study of Gene Expression Profiling and Orthodentic Appliances, run by Kurdistan Higher Council of Medical Specialties at 1 site in Iraq.
Trial summary
Understanding the biological events during fixed orthodontic treatment is essential for optimizing treatment strategies, predicting patient response, and minimizing adverse effects. Read more about this study
- Who is it for?
- Ages 15 to 25 years
- Conditions the study is for
- Gene Expression Profiling, Orthodentic Appliances
- What is being tested?
- PCR
- How many people
- 24 participants
- Where
- 1 siteIraq
- Study dates
- 12 Oct 2025to Feb 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Twenty-four patients (mean age 18.5 ± 3.2 years) who were receiving fixed orthodontic care were enrolled in this investigation.
Who may be able to join
- 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.
Who cannot join
- 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. -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Gene Expression Profiling, Orthodentic Appliances
- Being tested
- PCR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCRDiagnostic 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study start12 Oct 2025
- Primary completionFeb 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gene Expression ProfilingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kurdistan Higher Council of Medical Specialties
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shehab Ahmed Hamad, Kurdistan Higher Council of Medical Specialties
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07303647
- Sponsor's protocol ID
- 2561
- Status last verified
- Dec 2025
- First submitted
- 7 Dec 2025
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 38028229
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expression of Genes Related to Bone Metabolism in Saliva of Patients During Early Fixed Orthodontic Treatment: a Prospective Clinical Study
- ClinicalTrials.gov ID
- NCT07303647
- Acronym / sponsor ID
- 2561
- Conditions
- Gene Expression Profiling, Orthodentic Appliances
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Kurdistan Higher Council of Medical SpecialtiesUniversity, hospital or other
- Study start
- 12 Oct 2025 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 26 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Twenty-four patients (mean age 18.5 ± 3.2 years) who were receiving fixed orthodontic care were enrolled in this investigation.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (6 listed)
- periodontal disease
- smoking or any form of tobacco use
- pregnancy or lactation
- prior orthodontic treatment
- craniofacial syndromes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PCRUnstimulated 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. | Diagnostic test | – |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
- Background: PubMed 38028229Nugraha 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gene Expression Profiling and Orthodentic Appliances, run by Kurdistan Higher Council of Medical Specialties at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
salivary genes of bone metabolism (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07303647, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2025.