FractalsNCT07752485
Effects of Long-Term Antihistamine Use on Mandibular Bone in Children
An observational study of Fractals and Panoramic Radiography, run by Recep Tayyip Erdogan University Training and Research Hospital.
Trial summary
The purpose of this retrospective radiographic study is to evaluate the effects of long-term H1 antihistamine use on mandibular trabecular bone structure in children aged 8-10 years. Read more about this study
- Who is it for?
- Ages 8 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Fractals, Panoramic Radiography
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- 3 Aug 2026to 3 Sep 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 8 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: The study population will consist of children aged 8 to 10 years who attended the Department of Oral and Maxillofacial Radiology at Recep Tayyip Erdoğan University Faculty of Dentistry and had diagnostic-quality digital panoramic radiographs obtained as part of routine dental care. Participants will include children receiving long-term H1 antihistamine therapy, allergic children without antihistamine therapy, and age- and sex-matched healthy controls.
Who may be able to join
- Children aged 8 to 10 years.
- Availability of a diagnostic-quality digital panoramic radiograph obtained as part of routine dental care.
- Presence of complete mandibular permanent first molars and permanent incisors.
- Belonging to one of the following study groups:
- Children receiving regular H1 antihistamine therapy for at least 12 months.
- Children diagnosed with an allergic disease who have not received H1 antihistamine therapy during the previous 12 months.
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- Healthy children without allergic disease or long-term antihistamine use.
- Availability of complete medical and dental records. Exclusion Criteria
- History of systemic diseases or conditions known to affect bone metabolism.
- Use of medications affecting bone metabolism (other than H1 antihistamines in the antihistamine group).
- Craniofacial anomalies or syndromes.
- History of orthodontic treatment.
- Previous mandibular trauma or surgery.
- Presence of radiographic pathology affecting the mandibular regions of interest (e.g., cysts, tumors, fractures, or extensive bone lesions).
- Poor-quality panoramic radiographs with positioning errors or artifacts that interfere with image analysis.
- Missing permanent first molars or incomplete eruption of teeth required for the analysis.
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effects of Long-Term H1 Antihistamine Use on Mandibular Trabecular Bone Structure and Panoramic Mandibular Index in Children: A Retrospective Radiographic Study
The purpose of this retrospective radiographic study is to evaluate the effects of long-term H1 antihistamine use on mandibular trabecular bone structure in children aged 8-10 years. Mandibular trabecular bone will be assessed using fractal dimension analysis and the panoramic mandibular index on digital panoramic radiographs. Three groups will be compared: children receiving long-term H1 antihistamine therapy, allergic children without antihistamine use, and age- and sex-matched healthy controls. The findings will provide information on whether long-term antihistamine therapy is associated with alterations in mandibular bone microarchitecture.
- Conditions
- Fractals, Panoramic Radiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Children Receiving Long-Term H1 Antihistamine Therapy | Children aged 8-10 years who have been receiving H1 antihistamine therapy regularly for at least one year. | |
| Allergic Children Without Antihistamine Therapy | Children aged 8-10 years diagnosed with allergic disease who have not received H1 antihistamine therapy during the previous year. | |
| Healthy Controls | Age- and sex-matched healthy children without allergic disease or long-term antihistamine use. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mandibular Trabecular Bone Structure Assessed by Fractal Dimension Analysis
Mandibular trabecular bone structure will be evaluated on digital panoramic radiographs using fractal dimension analysis based on the box-counting method. Fractal dimension measurements will be performed bilaterally in three mandibular regions of interest: the subcortical region of the mandibular condyle, the supracortical region above the mandibular angle, and the dentate alveolar region distal to the mental foramen and superior to the mandibular canal. The right and left measurements for each region will be averaged to obtain one fractal dimension value per participant for each region. Fractal dimension values range from 1 to 2, with higher values indicating greater trabecular bone complexity. Values will be compared among children receiving long-term H1 antihistamine therapy, allergic children without antihistamine use, and healthy controls.
Measured: Baseline (retrospective panoramic radiographic assessment)
Secondary outcomes (2)
Panoramic Mandibular Index (PMI)
The panoramic mandibular index (PMI) will be calculated on digital panoramic radiographs as the ratio of mandibular cortical width to the distance between the inferior border of the mandible and the inferior margin of the mental foramen. Measurements will be performed bilaterally, and the mean value of the right and left sides will be used for statistical analysis. Higher PMI values indicate relatively greater mandibular cortical thickness. Values will be compared among children receiving long-term H1 antihistamine therapy, allergic children without antihistamine use, and healthy controls.
Measured: Baseline (retrospective panoramic radiographic assessment)
Klemetti Index (Mandibular Cortical Index, MCI)
The Klemetti Index (Mandibular Cortical Index, MCI) will be assessed on digital panoramic radiographs by evaluating the endosteal margin of the mandibular cortex distal to the mental foramen. The mandibular cortex will be classified into three categories: C1 (normal cortex), C2 (moderately eroded cortex), and C3 (severely eroded and porous cortex). Higher categories indicate greater cortical erosion and reduced mandibular cortical integrity. The distribution of MCI categories will be compared among children receiving long-term H1 antihistamine therapy, allergic children without antihistamine use, and healthy controls.
Measured: Baseline (retrospective panoramic radiographic assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start3 Aug 2026 (estimated)
- Primary completion30 Aug 2026 (estimated)
- Study completion3 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FractalsStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DİLARA NİL GÜNAÇAR, Recep Tayyip Erdogan University Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07752485
- Sponsor's protocol ID
- 2026/19
- Status last verified
- Aug 2026
- First submitted
- 3 Aug 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Long-Term H1 Antihistamine Use on Mandibular Trabecular Bone Structure and Panoramic Mandibular Index in Children: A Retrospective Radiographic Study
- ClinicalTrials.gov ID
- NCT07752485
- Acronym / sponsor ID
- 2026/19
- Conditions
- Fractals, Panoramic Radiography
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research HospitalUniversity, hospital or other
- Study start
- 3 Aug 2026 (estimated)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 3 Sep 2026 (estimated)
- First posted
- 7 Aug 2026 (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.
The purpose of this retrospective radiographic study is to evaluate the effects of long-term H1 antihistamine use on mandibular trabecular bone structure in children aged 8-10 years. Mandibular trabecular bone will be assessed using fractal dimension analysis and the panoramic mandibular index on digital panoramic radiographs. Three groups will be compared: children receiving long-term H1 antihistamine therapy, allergic children without antihistamine use, and age- and sex-matched healthy controls. The findings will provide information on whether long-term antihistamine therapy is associated with alterations in mandibular bone microarchitecture.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Children Receiving Long-Term H1 Antihistamine Therapy | – | –Children aged 8-10 years who have been receiving H1 antihistamine therapy regularly for at least one year. |
| Allergic Children Without Antihistamine Therapy | – | –Children aged 8-10 years diagnosed with allergic disease who have not received H1 antihistamine therapy during the previous year. |
| Healthy Controls | – | –Age- and sex-matched healthy children without allergic disease or long-term antihistamine use. |
Who may qualify
- Ages
- 8 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The study population will consist of children aged 8 to 10 years who attended the Department of Oral and Maxillofacial Radiology at Recep Tayyip Erdoğan University Faculty of Dentistry and had diagnostic-quality digital panoramic radiographs obtained as part of routine dental care. Participants will include children receiving long-term H1 antihistamine therapy, allergic children without antihistamine therapy, and age- and sex-matched healthy controls.
Key inclusion criteria (16 listed)
- Children aged 8 to 10 years.
- Availability of a diagnostic-quality digital panoramic radiograph obtained as part of routine dental care.
- Presence of complete mandibular permanent first molars and permanent incisors.
- Belonging to one of the following study groups:
- Children receiving regular H1 antihistamine therapy for at least 12 months.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mandibular Trabecular Bone Structure Assessed by Fractal Dimension Analysis
Time frame: Baseline (retrospective panoramic radiographic assessment)
Mandibular trabecular bone structure will be evaluated on digital panoramic radiographs using fractal dimension analysis based on the box-counting method. Fractal dimension measurements will be performed bilaterally in three mandibular regions of interest: the subcortical region of the mandibular condyle, the supracortical region above the mandibular angle, and the dentate alveolar region distal to the mental foramen and superior to the mandibular canal. The right and left measurements for each region will be averaged to obtain one fractal dimension value per participant for each region. Fractal dimension values range from 1 to 2, with higher values indicating greater trabecular bone complexity. Values will be compared among children receiving long-term H1 antihistamine therapy, allergic children without antihistamine use, and healthy controls.
2 secondary outcomes
Panoramic Mandibular Index (PMI)
Time frame: Baseline (retrospective panoramic radiographic assessment)
Klemetti Index (Mandibular Cortical Index, MCI)
Time frame: Baseline (retrospective panoramic radiographic assessment)
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 7 Aug 2026.
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Fractals and Panoramic Radiography, run by Recep Tayyip Erdogan University Training and Research Hospital.
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 16 inclusion and 0 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: opening soon, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact dilara nil günaçar (05412940104, dilaranil.tomrukcu@erdogan.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mandibular Trabecular Bone Structure Assessed by Fractal Dimension Analysis (time frame: Baseline (retrospective panoramic radiographic assessment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Aug 2026; AzTrials last refreshed its copy on 7 Nov 2026.