An observational study in Fractals and Panoramic Radiography, sponsored by Recep Tayyip Erdogan University Training and Research Hospital. Not yet recruiting. Open to participants aged 8 Years to 10 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-07.
Sponsored by Recep Tayyip Erdogan University Training and Research Hospital · Observational
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.
Recep Tayyip Erdogan University Training and Research Hospital is the lead sponsor of 88 studies on the registry; 19 are open to participants now.
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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.
Inclusion Criteria
Children aged 8-10 years who have been receiving H1 antihistamine therapy regularly for at least one year.
Children aged 8-10 years diagnosed with allergic disease who have not received H1 antihistamine therapy during the previous year.
Age- and sex-matched healthy children without allergic disease or long-term antihistamine use.
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.
Time frame: Baseline (retrospective panoramic radiographic assessment)
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.
Time frame: 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.
Time frame: Baseline (retrospective panoramic radiographic assessment)
No study locations are listed for this record.
Start is estimated for Aug 2026; primary completion for Aug 2026, 0 months later.
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Recep Tayyip Erdogan University Training and Research Hospital