An interventional study of Intraosseous Anaesthesia in Haemophilia A, Haemophilia B and Dental Caries, sponsored by Ankara Yildirim Beyazıt University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 4 Years to 12 Years. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Ankara Yildirim Beyazıt University · Not applicable, Interventional, and Treatment
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.
- Study Design and Participants:
The study will be conducted at the Paediatric Dental Clinic of Ankara Bilkent City Hospital in collaboration with the Department of Paediatric Dentistry, Ankara Yildirim Beyazit University.
Children aged 4-12 years with a confirmed diagnosis of haemophilia A or B will be assessed for eligibility. Participants must have at least one maxillary or mandibular primary or permanent molar requiring restorative treatment under local anaesthesia, with dentine caries without pulpal involvement (CAST score 4 or 5).
Before treatment, demographic and medical information, including haemophilia type and severity, inhibitor status, routine prophylactic regimen and emicizumab use, will be recorded. Oral health status will be assessed using the dmft/DMFT and CAST indices. A paediatric haematologist will confirm that no additional systemic haemostatic treatment is required and that the routine prophylactic regimen remains unchanged.
- Intraosseous Anaesthesia Procedure:
Intraosseous anaesthesia will be administered using the SleeperOne 5 computer-controlled local anaesthetic delivery system (Dental Hi Tec, France) with 4% articaine containing 1:100,000 epinephrine.
After radiographic assessment of the injection site, superficial gingival anaesthesia will be provided using the low-flow injection mode. Subsequently, the needle will be advanced through the cortical bone into the cancellous bone, and 1 mL of local anaesthetic solution will be administered using the slow injection mode. Pulse rate will be monitored during the procedure.
- Safety Assessment:
Following anaesthesia, pressure will be applied to the injection site for 30 seconds. Injection-site bleeding and haematoma will be assessed at 1, 2, 4 and 10 minutes after injection. If a haematoma develops, its maximum diameter will be measured using a calliper. Any requirement for additional haemostatic measures, factor replacement or antifibrinolytic treatment will be recorded.
- Restorative Treatment and Clinical Effectiveness Assessment:
Restorative treatment will be performed according to standard clinical procedures. Anaesthetic success will be defined as completion of the planned restorative treatment without supplementary local anaesthesia due to pain. Any supplementary anaesthesia required will be recorded.
Pain during anaesthesia and restorative treatment will be assessed using the Wong-Baker FACES Pain Rating Scale immediately after each procedure. Pulse rate will be recorded at baseline, during anaesthesia and at predefined stages of restorative treatment.
- Postoperative Follow-up:
Parents or legal guardians will be contacted by telephone 24 hours after treatment. Postoperative bleeding, haematoma, jaw stiffness, contact with or presentation to the treatment centre, requirements for haemostatic treatment and other adverse events will be recorded.
844 studies on the registry are indexed under Hemophilia A; 138 are open to participants now.
This study's planned enrollment of 20 is below the median of 30 across 499 interventional studies indexed under Hemophilia A.
Browse Hemophilia A studies →Ankara Yildirim Beyazıt University is the lead sponsor of 241 studies on the registry; 54 are open to participants now.
Counted across the registry records on this site, refreshed daily.
**Inclusion Criteria:**
**Exclusion Criteria:**
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Children aged 4-12 years with haemophilia A or B who require restorative treatment of eligible maxillary or mandibular primary or permanent molars receive intraosseous anaesthesia using the SleeperOne 5 system.
Procedure: Intraosseous Anaesthesia
Intraosseous anaesthesia will be delivered using the SleeperOne 5 computer-controlled local anaesthetic delivery system with a 30-gauge (0.30 x 9 mm) Effitec needle and 4% articaine with 1:100,000 epinephrine. After superficial gingival anaesthesia, the needle will be advanced through the cortical bone of the interdental septum into the cancellous bone and 1 mL of the solution administered using the slow injection mode before restorative treatment of an eligible maxillary or mandibular molar.
Injection-Site Bleeding Following Intraosseous Anaesthesia
The presence or absence of bleeding at the injection site will be assessed at 1, 2, 4, and 10 minutes after intraosseous anaesthesia. The number and percentage of participants with injection-site bleeding at each time point will be recorded. Any requirement for additional local haemostatic measures will also be documented.
Time frame: 1, 2, 4, and 10 minutes after administration of intraosseous anaesthesia.
Injection-Site Haematoma Occurrence Following Intraosseous Anaesthesia
The presence or absence of haematoma at the injection site will be assessed at 1, 2, 4, and 10 minutes after intraosseous anaesthesia. The number and percentage of participants with injection-site haematoma at each time point will be recorded.
Time frame: 1, 2, 4, and 10 minutes after administration of intraosseous anaesthesia.
Maximum Diameter of Injection-Site Haematoma Following Intraosseous Anaesthesia
In participants who develop an injection-site haematoma, the maximum diameter of the haematoma will be measured in millimetres (mm) using a calliper at 1, 2, 4, and 10 minutes after intraosseous anaesthesia. Measurements will be recorded at each time point when a haematoma is present.
Time frame: 1, 2, 4, and 10 minutes after administration of intraosseous anaesthesia.
Participants With Postoperative Adverse Events Within 24 Hours After Intraosseous Anaesthesia
Postoperative adverse events will be assessed through a telephone interview with parents or legal guardians 24 hours after the procedure. Injection-site bleeding, haematoma, jaw stiffness, and other unexpected events will be recorded. Any contact with or presentation to the treatment centre and any requirement for factor replacement therapy or antifibrinolytic treatment (systemic or topical) due to bleeding or haematoma will also be documented. The number and percentage of participants experiencing at least one postoperative adverse event will be reported.
Time frame: Within 24 hours after the procedure, assessed by telephone follow-up at 24 hours.
Anaesthetic Success During Restorative Treatment
Anaesthetic success will be defined as completion of the planned restorative treatment without the need for supplementary local anaesthesia due to pain. Cases requiring supplementary local anaesthesia because of pain will be classified as anaesthetic failures. The number and percentage of participants with successful anaesthesia will be reported. The supplementary anaesthetic technique used, if any, will also be recorded.
Time frame: During restorative treatment, assessed immediately after completion of the procedure.
Wong-Baker FACES Pain Scores During Intraosseous Anaesthesia and Restorative Treatment
Pain will be assessed using the Wong-Baker FACES Pain Rating Scale at two stages: immediately after intraosseous anaesthesia to evaluate pain experienced during injection, and immediately after restorative treatment to evaluate pain experienced during the restorative procedure. The scale consists of six faces corresponding to scores of 0, 2, 4, 6, 8, and 10, with higher scores indicating greater pain. Both pain scores will be recorded for each participant and compared.
Time frame: Immediately after intraosseous anaesthesia and immediately after completion of restorative treatment, during the same treatment visit.
Pulse Rate During Intraosseous Anaesthesia and Restorative Treatment
Pulse rate will be measured using a pulse oximeter and recorded in beats per minute (bpm) at six predefined stages: baseline (before anaesthesia), during intraosseous anaesthesia, during cavity preparation, during matrix placement, during restorative material placement, and during finishing and polishing. Changes in pulse rate across these stages will be evaluated.
Time frame: Before intraosseous anaesthesia (baseline), during intraosseous anaesthesia, during cavity preparation, during matrix placement, during restorative material placement, and during finishing and polishing.
Plan to share: No
Start is estimated for Jan 2027; primary completion for Jul 2027, 6 months later.
Of 72 non-industry interventional studies with no phase under Hemophilia A, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 38. This study's planned 6 months is below that.
Counting every sponsor, half of 75 studies reached it within 11 months; a quarter within 5 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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