Haemophilia ANCT07916467
Safety of Intraosseous Anaesthesia in Children With Haemophilia
A study testing Intraosseous Anaesthesia in people with Haemophilia A and Haemophilia B, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Haemophilia A, Haemophilia B, Dental Caries
- What is being tested?
- Intraosseous Anaesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2027to 1 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Ankara Bilkent City Hospital
Ankara, Ankara, 06800
Gökçe Hilal ERDOĞAN, Research Assistant, +0905074398006, gokceerdogan06@gmail.com
Ayşe Işıl CİHAN, Professor, +0905325095961, isilcihan@yahoo.com
About this study
Official title: 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.
Read more
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.
Read the detailed description
- 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.
- Conditions
- Haemophilia A, Haemophilia B, Dental Caries
- Being tested
- Intraosseous Anaesthesia
- Keywords
- Haemophilia, Intraosseous anaesthesia, SleeperOne®5, Bleeding disorders, Paediatric dentistry, Computer-controlled local anesthesia
- Medical subject headings
- Hemophilia A, Hemophilia B, Dental Caries, Hemostatic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraosseous AnaesthesiaProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Intraosseous Anaesthesia | Experimental | 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. Receives: Procedure: Intraosseous Anaesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Within 24 hours after the procedure, assessed by telephone follow-up at 24 hours.
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Before intraosseous anaesthesia (baseline), during intraosseous anaesthesia, during cavity preparation, during matrix placement, during restorative material placement, and during finishing and polishing.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start1 Jan 2027 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Haemophilia AStudies of the same condition, open and under way.
- More trials run by Ankara Yildirim Beyazıt UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All enrolled children receive protocol-assigned intraosseous anaesthesia for restorative treatment of eligible molars. There is no comparison arm.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Collaborators
- Ankara City Hospital Bilkent
- Responsible party
- Principal investigator, AYŞE IŞIL CİHAN, Ankara Yildirim Beyazıt University
- Investigators
- Ayşe Işıl Cihan, Professor, Principal investigator, Department of Paediatric Dentistry, Faculty of Dentistry, Ankara Yıldırım Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07916467
- Sponsor's protocol ID
- TABED 2-26-2856
- Status last verified
- Oct 2026
- First submitted
- 30 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kuhnisch J, Daublander M, Klingberg G, Dougall A, Spyridonos Loizides M, Stratigaki E, Amar JL, Anttonen V, Duggal M, Gizani S. Best clinical practice guidance for local analgesia in paediatric dentistry: an EAPD policy document. Eur Arch Paediatr Dent. 2017 Oct;18(5):313-321. doi: 10.1007/s40368-017-0311-y. Epub 2017 Oct 11.
PubMed 29022286Srivastava A, Santagostino E, Dougall A, Kitchen S, Sutherland M, Pipe SW, Carcao M, Mahlangu J, Ragni MV, Windyga J, Llinas A, Goddard NJ, Mohan R, Poonnoose PM, Feldman BM, Lewis SZ, van den Berg HM, Pierce GF; WFH Guidelines for the Management of Hemophilia panelists and co-authors. WFH Guidelines for the Management of Hemophilia, 3rd edition. Haemophilia. 2020 Aug;26 Suppl 6:1-158. doi: 10.1111/hae.14046. Epub 2020 Aug 3. No abstract available.
PubMed 32744769Dougall A, Apperley O, Smith G, Madden L, Parkinson L, Daly B. Safety of buccal infiltration local anaesthesia for dental procedures. Haemophilia. 2019 Mar;25(2):270-275. doi: 10.1111/hae.13695. Epub 2019 Feb 28.
PubMed 30817070
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Clinical Effectiveness of Intraosseous Anesthesia for Restorative Treatment of Molars in Children With Hemophilia
- ClinicalTrials.gov ID
- NCT07916467
- Acronym / sponsor ID
- TABED 2-26-2856
- Conditions
- Haemophilia A, Haemophilia B, Dental Caries
- Keywords
- Haemophilia, Intraosseous anaesthesia, SleeperOne®5, Bleeding disorders, Paediatric dentistry, Computer-controlled local anesthesia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Collaborators
- Ankara City Hospital Bilkent
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 4 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All enrolled children receive protocol-assigned intraosseous anaesthesia for restorative treatment of eligible molars. There is no comparison arm.
| Arm | Type | Receives |
|---|---|---|
| Intraosseous Anaesthesia | Experimental | Procedure: Intraosseous AnaesthesiaChildren 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. |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraosseous AnaesthesiaIntraosseous 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. | Procedure or surgery | Intraosseous Anaesthesia |
Primary outcome
Injection-Site Bleeding Following Intraosseous Anaesthesia
Time frame: 1, 2, 4, and 10 minutes after administration of 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.
Injection-Site Haematoma Occurrence Following Intraosseous Anaesthesia
Time frame: 1, 2, 4, and 10 minutes after administration of 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.
Maximum Diameter of Injection-Site Haematoma Following Intraosseous Anaesthesia
Time frame: 1, 2, 4, and 10 minutes after administration of 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.
Participants With Postoperative Adverse Events Within 24 Hours After Intraosseous Anaesthesia
Time frame: Within 24 hours after the procedure, assessed by telephone follow-up at 24 hours.
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.
3 secondary outcomes
Anaesthetic Success During Restorative Treatment
Time frame: During restorative treatment, assessed immediately after completion of the procedure.
Wong-Baker FACES Pain Scores During Intraosseous Anaesthesia and Restorative Treatment
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
Time frame: Before intraosseous anaesthesia (baseline), during intraosseous anaesthesia, during cavity preparation, during matrix placement, during restorative material placement, and during finishing and polishing.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Background: PubMed 29022286Kuhnisch J, Daublander M, Klingberg G, Dougall A, Spyridonos Loizides M, Stratigaki E, Amar JL, Anttonen V, Duggal M, Gizani S. Best clinical practice guidance for local analgesia in paediatric dentistry: an EAPD policy document. Eur Arch Paediatr Dent. 2017 Oct;18(5):313-321. doi: 10.1007/s40368-017-0311-y. Epub 2017 Oct 11.
- Background: PubMed 32744769Srivastava A, Santagostino E, Dougall A, Kitchen S, Sutherland M, Pipe SW, Carcao M, Mahlangu J, Ragni MV, Windyga J, Llinas A, Goddard NJ, Mohan R, Poonnoose PM, Feldman BM, Lewis SZ, van den Berg HM, Pierce GF; WFH Guidelines for the Management of Hemophilia panelists and co-authors. WFH Guidelines for the Management of Hemophilia, 3rd edition. Haemophilia. 2020 Aug;26 Suppl 6:1-158. doi: 10.1111/hae.14046. Epub 2020 Aug 3. No abstract available.
- Background: PubMed 30817070Dougall A, Apperley O, Smith G, Madden L, Parkinson L, Daly B. Safety of buccal infiltration local anaesthesia for dental procedures. Haemophilia. 2019 Mar;25(2):270-275. doi: 10.1111/hae.13695. Epub 2019 Feb 28.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ayşe Işıl Cihan, Professor principal investigator
Department of Paediatric Dentistry, Faculty of Dentistry, Ankara Yıldırım Beyazıt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraosseous Anaesthesia in people with Haemophilia A and Haemophilia B, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ayşe Işıl Cihan, Professor (+0905325095961, isilcihan@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Injection-Site Bleeding Following Intraosseous Anaesthesia (time frame: 1, 2, 4, and 10 minutes after administration of intraosseous anaesthesia.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07916467, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.