Effects of Long-Term Antihistamine Use on Mandibular Bone in Children
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age8-10
SponsorRecep Tayyip Erdogan University Training and Research Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Children receiving regular H1 antihistamine therapy for at least 12 months.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Case-control
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
84 Participants
are grouped into 3 trial groupsGroup A: Children Receiving Long-Term H1 Antihistamine Therapy
Group B: Allergic Children Without Antihistamine Therapy
Group C: Healthy Controls
Trial outcomes
Primary outcomes
1
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)Secondary outcomes
1
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)2
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)Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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