Effects of Long-Term H1 Antihistamine Use on Mandibular Trabecular Bone Structure and Panoramic Mandibular Index in Children: A Retrospective Radiographic Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 84
- 主要终点
- Mandibular Trabecular Bone Structure Assessed by Fractal Dimension Analysis
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 8 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
结局指标
主要结局
Mandibular Trabecular Bone Structure Assessed by Fractal Dimension Analysis
时间窗: 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.
次要结局
- Panoramic Mandibular Index (PMI)(Baseline (retrospective panoramic radiographic assessment))
- Klemetti Index (Mandibular Cortical Index, MCI)(Baseline (retrospective panoramic radiographic assessment))
研究者
DİLARA NİL GÜNAÇAR
Associate Professor
Recep Tayyip Erdogan University Training and Research Hospital