Effects of Long-Term Antihistamine Use on Mandibular Bone in Children
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Fractals, Panoramic Radiography. Basic parameters: 8 years — 10 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effects of Long-Term H1 Antihistamine Use on Mandibular Trabecular Bone Structure and Panoramic Mandibular Index in Children: A Retrospective Radiographic Study
Overview
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.
Primary outcome measures
- Mandibular Trabecular Bone Structure Assessed by Fractal Dimension Analysis [Time frame: Baseline (retrospective panoramic radiographic assessment)]
Secondary outcome measures (2)
- Panoramic Mandibular Index (PMI) [Time frame: Baseline (retrospective panoramic radiographic assessment)]
- Klemetti Index (Mandibular Cortical Index, MCI) [Time frame: Baseline (retrospective panoramic radiographic assessment)]
Eligibility criteria
Inclusion criteria
- 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.
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07752485 · 2026/19