NCT07916467Not yet recruiting
Safety of Intraosseous Anaesthesia in Children With Haemophilia
Safety and Clinical Effectiveness of Intraosseous Anesthesia for Restorative Treatment of Molars in Children With Hemophilia
Source: ClinicalTrials.gov · Last updated 4 Nov 2026
Brief summary (registry, in English)
Effective local anaesthesia is essential for safe and comfortable dental treatment in children with haemophilia. However, conventional nerve block techniques, particularly inferior alveolar nerve block, carry an increased risk of bleeding and haematoma formation because of their administration into deep tissues. Therefore, alternative local anaesthetic techniques that may reduce the need for deep nerve blocks are of particular importance in this patient population. Intraosseous anaesthesia has been proposed as a potential alternative to conventional nerve block techniques. Although previous clinical studies have demonstrated promising results in healthy children, its safety and clinical effectiveness in children with haemophilia have not yet been established. This prospective, single-group, open-label interventional clinical study aims to evaluate the safety and clinical effectiveness of intraosseous anaesthesia during restorative treatment of maxillary and mandibular primary and permanent molars in children aged 4-12 years with haemophilia A or B. Intraosseous anaesthesia will be administered using the SleeperOne 5 computer-controlled local anaesthetic delivery system, without additional systemic haemostatic treatment in children who do not require such treatment following preoperative haematological assessment. Routine prophylactic regimens will remain unchanged. Safety will be assessed through injection-site bleeding and haematoma evaluations at 1, 2, 4 and 10 minutes and monitoring of adverse events up to 24 hours after the procedure. Clinical effectiveness will be evaluated based on anaesthetic success, pain scores and pulse rate measurements.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 30 Oct 2026
- Start date
- 1 Jan 2027
- Primary completion date
- 1 Jul 2027
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Diseases
- Haemophilia
- NCT number
- NCT07916467
What you commit to
- Study type: Interventional
- Planned participants: 20
- From 1 Jan 2027 to the primary completion date, 1 Jul 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- **Inclusion Criteria:**
- Children aged 4-12 years.
- Confirmed diagnosis of haemophilia A or B.
- Presence of at least one maxillary or mandibular primary or permanent molar with a dentine caries lesion requiring restorative treatment under local anaesthesia, without pulpal involvement (CAST score 4 or 5).
- Preoperative assessment by a paediatric haematologist confirming that no additional systemic haemostatic treatment is required and that the routine prophylactic regimen has not been interrupted.
- No preoperative factor replacement or antifibrinolytic treatment (systemic or topical), regardless of baseline factor levels.
- Written informed consent from the parent or legal guardian and age-appropriate written assent from the child.
- **Exclusion Criteria:**
- Presence of acute odontogenic infection at the planned intraosseous injection site.
- Known history of allergy to the local anaesthetic solution or any of its components.
- Requirement for additional systemic haemostatic treatment at home before the procedure.
- Lack of informed consent for participation in the study.
Age in the registry: 4 years to 12 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ankara Bilkent City Hospital Coordinator of this site? Confirm its status | Ankara | Türkiye | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.