Intraosseous Anaesthesia for Dental Fillings in Children With Haemophilia
Tests intraosseous anaesthesia for molar fillings in children with haemophilia A or B.
Plain-language title generated from the registry record
Registry title: Safety of Intraosseous Anaesthesia in Children With Haemophilia
Key facts
- Where
- Ankara, TürkiyeSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for children aged 4-12 years with haemophilia A or B who need a tooth filling on a molar under local anaesthesia. It tests intraosseous anaesthesia (an injection into the bone next to the tooth).
- Age
- 4 to 12 years
- Sex
- All sexes can join.
- Disease stage
- Confirmed haemophilia A or B. At least one molar (milk or permanent) with a cavity in the dentine that needs a filling, with no involvement of the tooth pulp (CAST score 4 or 5).
- Earlier treatment
- No factor replacement or antifibrinolytic treatment (by mouth, injection or applied locally) before the procedure. The usual preventive treatment must not have been stopped. A children's blood specialist must confirm that no extra clotting treatment is needed.
Main reasons for not taking part
- Acute tooth infection at the planned injection site
- Known allergy to the local anaesthetic or its ingredients
- Needs extra clotting treatment at home before the procedure
- No informed consent
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 4 and 12 years old?
Source: NCT07916467, who can take part
Where in Türkiye
- Ankara Bilkent City HospitalAnkara, TürkiyeContact: Gökçe Hilal ERDOĞAN, Research AssistantNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Ankara Yildirim Beyazıt University
- Trial code
- NCT07916467
- Record updated
- 4 November 2026
- Original description
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.Read full original descriptionShow less
Safety and Clinical Effectiveness of Intraosseous Anesthesia for Restorative Treatment of Molars in Children With Hemophilia
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.
**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.