How two local anesthesia techniques affect pulp hemostasis during pulpotomy in primary molars

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, split-mouth study compares two local anesthesia techniques in children undergoing pulpotomy for mandibular primary molars. Each participant receives both anesthesia methods in random order to assess their effect on pulp hemostasis time, as well as pain, heart rate, and oxygen saturation during the procedure. The conventional inferior alveolar nerve block is contrasted with computer-controlled intraosseous anesthesia using the QuickSleeper 5 system. Outcomes include time to hemostasis and secondary clinical measures to determine if one technique offers advantages in pediatric dental procedures. Eligible participants are ASA I-II children aged 6–9 with indications for pulpotomy in both mandibular primary second molars, recruited at Afyonkarahisar Health Sciences University in Turkey.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Where it's running

• Afyonkarahisar Health Sciences University, Faculty of Dentistry
  Afyonkarahisar, Afyonkarahisar, Turkey (Türkiye) Recruiting

Study contacts

• Study coordinator: Ayça Hande Sari
• Email: aycahande94@gmail.com
• Phone: +905065143594

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.