Pulpotomies Primary TeethNCT07810452
Effect of Local Anesthesia Techniques on Pulp Hemostasis in Primary Molars
A study testing Inferior Alveolar Nerve Block Anesthesia in people with Pulpotomies Primary Teeth, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to compare the effects of two local anesthesia techniques on pulp hemostasis time during pulpotomy treatment of mandibular primary molars in children aged 6-9 years. Read more about this study
- Who is it for?
- Ages 6 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulpotomies Primary Teeth
- What is being tested?
- Inferior Alveolar Nerve Block Anesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2026to 26 Feb 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 6 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 6-9 years.
- Presence of a pulpotomy indication in both mandibular primary second molars (teeth 75 and 85).
- Systemically healthy children classified as ASA physical status I or II.
- No known coagulation disorders.
- No use of analgesic, anti-inflammatory, antithrombotic, or antipyretic medications within the previous 7 days.
- Sufficient cooperation and compliance to allow completion of the planned clinical procedures.
- Written informed consent obtained from a parent or legal guardian for participation in the study.
- No history of a serious adverse reaction or complication associated with either of the local anesthesia techniques used in the study.
Who cannot join
- Children with systemic health conditions classified as ASA physical status III or higher.
- Known allergy or hypersensitivity to the local anesthetic agents or other dental materials used in the study.
- Presence of a known coagulation disorder or use of analgesic, anti-inflammatory, antithrombotic, or antipyretic medications within the previous 7 days.
- Presence of severe infection, pulp necrosis, advanced root resorption, or any other dental condition requiring a treatment approach other than pulpotomy in the mandibular primary second molars.
- Insufficient cooperation or behavioral difficulties that would prevent completion of the planned clinical procedures.
- History of a serious adverse reaction or complication associated with either of the local anesthesia techniques used in the study.
- Inability to comply with the study protocol or attend the scheduled study visits.
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, 1 recruiting
- Recruiting
Afyonkarahisar Health Sciences University, Faculty of Dentistry
Afyonkarahisar, Afyonkarahisar, 03030
Ayça Hande Sari, +905065143594, aycahande94@gmail.com
About this study
Official title: Effect of Mandibular Anesthesia and Computer-Controlled Local Anesthesia on Pulp Hemostasis Time During Pulpotomy Treatment of Mandibular Primary Molars: A Split-Mouth Study
The goal of this clinical trial is to compare the effects of two local anesthesia techniques on pulp hemostasis time during pulpotomy treatment of mandibular primary molars in children aged 6-9 years.
The main questions it aims to answer are:
Read more
Does the local anesthesia technique affect the time required to achieve pulp hemostasis during pulpotomy? Are there differences between the two anesthesia techniques in terms of pain, heart rate, and oxygen saturation during treatment?
Researchers will compare conventional inferior alveolar nerve block anesthesia with computer-controlled intraosseous local anesthesia using the QuickSleeper 5 system to determine whether the anesthesia technique affects pulp hemostasis time and the secondary clinical outcomes.
Each participant will receive both anesthesia techniques in a randomized order using a split-mouth design. Participants will:
Receive conventional inferior alveolar nerve block anesthesia for pulpotomy treatment of one mandibular primary molar.
Receive computer-controlled intraosseous local anesthesia using the QuickSleeper 5 system for pulpotomy treatment of the contralateral mandibular primary molar at a separate treatment session.
Have pulp hemostasis time recorded during each pulpotomy procedure. Have pain, heart rate, and oxygen saturation assessed during the treatment procedures.
- Conditions
- Pulpotomies Primary Teeth
- Being tested
- Inferior Alveolar Nerve Block Anesthesia, Computer-Controlled Intraosseous Anesthesia
- Keywords
- Primary Molars, Pulp Hemostasis, Computer-Controlled Local Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inferior Alveolar Nerve Block AnesthesiaProcedure or surgery
Conventional inferior alveolar nerve block anesthesia will be administered before pulpotomy treatment of the mandibular primary molar using a standard dental syringe and an articaine-based local anesthetic solution (Ultracain D-S Forte). After adequate anesthesia is achieved, pulpotomy will be performed according to the study protocol. Pulp hemostasis time will be recorded following removal of the coronal pulp tissue.
Computer-Controlled Intraosseous AnesthesiaProcedure or surgery
Computer-controlled intraosseous local anesthesia will be administered using the QuickSleeper 5 system (Dental Hi-Tec, France) and an articaine-based local anesthetic solution (Ultracain D-S Forte) before pulpotomy treatment of the mandibular primary molar. After adequate anesthesia is achieved, pulpotomy will be performed according to the study protocol. Pulp hemostasis time will be recorded following removal of the coronal pulp tissue
| Study group | Role | What they receive |
|---|---|---|
| IANB Followed by Intraosseous Anesthesia | Experimental | Participants allocated to this sequence will receive conventional inferior alveolar nerve block (IANB) anesthesia for pulpotomy treatment of one mandibular primary molar at the first treatment session. At the second treatment session, computer-controlled intraosseous anesthesia will be administered for pulpotomy treatment of the contralateral mandibular primary molar. The time required to achieve pulp hemostasis will be recorded during both treatment sessions. Receives: Procedure: Inferior Alveolar Nerve Block Anesthesia; Procedure: Computer-Controlled Intraosseous Anesthesia |
| Intraosseous Anesthesia Followed by IANB | Experimental | Computer-controlled intraosseous local anesthesia will be administered using the QuickSleeper 5 system (Dental Hi-Tec, France) before pulpotomy treatment of the mandibular primary molar. After adequate anesthesia is achieved, pulpotomy will be performed according to the study protocol, and the time required to achieve pulp hemostasis will be recorded. Receives: Procedure: Inferior Alveolar Nerve Block Anesthesia; Procedure: Computer-Controlled Intraosseous Anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulp Hemostasis Time
The time required to achieve pulp hemostasis following removal of the coronal pulp tissue during pulpotomy will be recorded for each treatment session. Hemostasis will be assessed using standardized sterile cotton pellets and categorized according to the time required to achieve bleeding control: ≤2 minutes, >2 to 5 minutes, or failure to achieve hemostasis within 5 minutes.
Measured: During pulpotomy, up to 5 minutes after coronal pulp removal
Secondary outcomes (3)
Pain Intensity
Pain intensity will be assessed using the Wong-Baker FACES Pain Rating Scale. Participants will select the face that best represents their perceived pain. The scale ranges from 0 (no pain) to 10 (worst pain), with higher scores indicating greater pain intensity. Pain will be assessed after administration of local anesthesia and after completion of the pulpotomy procedure.
Measured: Immediately after local anesthesia administration and immediately after completion of the pulpotomy procedure, during each treatment visit
Heart Rate
Heart rate will be measured using a pulse oximeter and recorded as beats per minute (bpm) to evaluate physiological changes associated with the anesthesia and pulpotomy procedures.
Measured: Immediately before local anesthesia administration and immediately after local anesthesia administration, during each treatment visit
Peripheral Oxygen Saturation (SpO₂)
Peripheral oxygen saturation (SpO₂) will be measured using a pulse oximeter and recorded as a percentage (%) to evaluate physiological changes associated with the anesthesia and pulpotomy procedures.
Measured: Immediately before local anesthesia administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study start15 Apr 2026
- Primary completionFeb 2027 (estimated)
- Study completion26 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulpotomies Primary TeethStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Afyonkarahisar Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayça Hande Sari, Afyonkarahisar Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07810452
- Sponsor's protocol ID
- 26.GENEL.013
- Status last verified
- Sep 2026
- First submitted
- 3 Sep 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made publicly available due to participant confidentiality and privacy considerations.
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Mandibular Anesthesia and Computer-Controlled Local Anesthesia on Pulp Hemostasis Time During Pulpotomy Treatment of Mandibular Primary Molars: A Split-Mouth Study
- ClinicalTrials.gov ID
- NCT07810452
- Acronym / sponsor ID
- 26.GENEL.013
- Conditions
- Pulpotomies Primary Teeth
- Keywords
- Primary Molars, Pulp Hemostasis, Computer-Controlled Local Anesthesia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Afyonkarahisar Health Sciences UniversityUniversity, hospital or other
- Study start
- 15 Apr 2026 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- 26 Feb 2027 (estimated)
- First posted
- 9 Sep 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.
The goal of this clinical trial is to compare the effects of two local anesthesia techniques on pulp hemostasis time during pulpotomy treatment of mandibular primary molars in children aged 6-9 years.
The main questions it aims to answer are:
Does the local anesthesia technique affect the time required to achieve pulp hemostasis during pulpotomy? Are there differences between the two anesthesia techniques in terms of pain, heart rate, and oxygen saturation during treatment?
Researchers will compare conventional inferior alveolar nerve block anesthesia with computer-controlled intraosseous local anesthesia using the QuickSleeper 5 system to determine whether the anesthesia technique affects pulp hemostasis time and the secondary clinical outcomes.
Each participant will receive both anesthesia techniques in a randomized order using a split-mouth design. Participants will:
Receive conventional inferior alveolar nerve block anesthesia for pulpotomy treatment of one mandibular primary molar.
Receive computer-controlled intraosseous local anesthesia using the QuickSleeper 5 system for pulpotomy treatment of the contralateral mandibular primary molar at a separate treatment session.
Have pulp hemostasis time recorded during each pulpotomy procedure. Have pain, heart rate, and oxygen saturation assessed during the treatment procedures.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IANB Followed by Intraosseous Anesthesia | Experimental | Procedure: Inferior Alveolar Nerve Block Anesthesia, Procedure: Computer-Controlled Intraosseous AnesthesiaParticipants allocated to this sequence will receive conventional inferior alveolar nerve block (IANB) anesthesia for pulpotomy treatment of one mandibular primary molar at the first treatment session. At the second treatment session, computer-controlled intraosseous anesthesia will be administered for pulpotomy treatment of the contralateral mandibular primary molar. The time required to achieve pulp hemostasis will be recorded during both treatment sessions. |
| Intraosseous Anesthesia Followed by IANB | Experimental | Procedure: Inferior Alveolar Nerve Block Anesthesia, Procedure: Computer-Controlled Intraosseous AnesthesiaComputer-controlled intraosseous local anesthesia will be administered using the QuickSleeper 5 system (Dental Hi-Tec, France) before pulpotomy treatment of the mandibular primary molar. After adequate anesthesia is achieved, pulpotomy will be performed according to the study protocol, and the time required to achieve pulp hemostasis will be recorded. |
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Children aged 6-9 years.
- Presence of a pulpotomy indication in both mandibular primary second molars (teeth 75 and 85).
- Systemically healthy children classified as ASA physical status I or II.
- No known coagulation disorders.
- No use of analgesic, anti-inflammatory, antithrombotic, or antipyretic medications within the previous 7 days.
Key exclusion criteria (7 listed)
- Children with systemic health conditions classified as ASA physical status III or higher.
- Known allergy or hypersensitivity to the local anesthetic agents or other dental materials used in the study.
- Presence of a known coagulation disorder or use of analgesic, anti-inflammatory, antithrombotic, or antipyretic medications within the previous 7 days.
- Presence of severe infection, pulp necrosis, advanced root resorption, or any other dental condition requiring a treatment approach other than pulpotomy in the mandibular primary second molars.
- Insufficient cooperation or behavioral difficulties that would prevent completion of the planned clinical procedures.
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 |
|---|---|---|
| Inferior Alveolar Nerve Block AnesthesiaConventional inferior alveolar nerve block anesthesia will be administered before pulpotomy treatment of the mandibular primary molar using a standard dental syringe and an articaine-based local anesthetic solution (Ultracain D-S Forte). After adequate anesthesia is achieved, pulpotomy will be performed according to the study protocol. Pulp hemostasis time will be recorded following removal of the coronal pulp tissue. | Procedure or surgery | IANB Followed by Intraosseous Anesthesia, Intraosseous Anesthesia Followed by IANB |
| Computer-Controlled Intraosseous AnesthesiaComputer-controlled intraosseous local anesthesia will be administered using the QuickSleeper 5 system (Dental Hi-Tec, France) and an articaine-based local anesthetic solution (Ultracain D-S Forte) before pulpotomy treatment of the mandibular primary molar. After adequate anesthesia is achieved, pulpotomy will be performed according to the study protocol. Pulp hemostasis time will be recorded following removal of the coronal pulp tissue | Procedure or surgery | IANB Followed by Intraosseous Anesthesia, Intraosseous Anesthesia Followed by IANB |
Primary outcome
Pulp Hemostasis Time
Time frame: During pulpotomy, up to 5 minutes after coronal pulp removal
The time required to achieve pulp hemostasis following removal of the coronal pulp tissue during pulpotomy will be recorded for each treatment session. Hemostasis will be assessed using standardized sterile cotton pellets and categorized according to the time required to achieve bleeding control: ≤2 minutes, >2 to 5 minutes, or failure to achieve hemostasis within 5 minutes.
3 secondary outcomes
Pain Intensity
Time frame: Immediately after local anesthesia administration and immediately after completion of the pulpotomy procedure, during each treatment visit
Heart Rate
Time frame: Immediately before local anesthesia administration and immediately after local anesthesia administration, during each treatment visit
Peripheral Oxygen Saturation (SpO₂)
Time frame: Immediately before local anesthesia administration
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 14 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be made publicly available due to participant confidentiality and privacy considerations.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inferior Alveolar Nerve Block Anesthesia in people with Pulpotomies Primary Teeth, run by Afyonkarahisar Health Sciences 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 8 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 14 Sep 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 Ayça Hande Sari (+905065143594, aycahande94@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulp Hemostasis Time (time frame: During pulpotomy, up to 5 minutes after coronal pulp removal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Sep 2026.