Effects of Long-Term Antihistamine Use on Mandibular Bone in Children (NCT07752485) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Effects of Long-Term Antihistamine Use on Mandibular Bone in Children
84 participantsStarted 2026-08-03
Plain-language summary
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.
Who can participate
Age range
8 Years – 10 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mandibular Trabecular Bone Structure Assessed by Fractal Dimension Analysis