Effects of Long-Term Antihistamine Use on Mandibular Bone in Children

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.

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Key information

Conditions

Fractals Panoramic Radiography

Age range

8 year–10 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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.

Secondary outcomes

Panoramic Mandibular Index (PMI)

Time frame: Baseline (retrospective panoramic radiographic assessment)

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.
Klemetti Index (Mandibular Cortical Index, MCI)

Time frame: Baseline (retrospective panoramic radiographic assessment)

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.

Study contacts

Contact information is provided by the study sponsor or research team.

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CONTACT

[email protected]

05412940104

Sponsors and collaborators

Lead sponsor

Recep Tayyip Erdogan University Training and Research Hospital

Other

Registry information

Official study title

Effects of Long-Term H1 Antihistamine Use on Mandibular Trabecular Bone Structure and Panoramic Mandibular Index in Children: A Retrospective Radiographic Study

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: Aug 7, 2026
Registry last updated: Aug 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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