๐ฌIn plain words
What the trial is, and whether it could suit you
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:
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๐ Eligibility rules (as published)
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.
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What it tests
- Inferior Alveolar Nerve Block Anesthesia
- Computer-Controlled Intraosseous Anesthesia
Afyonkarahisar Health Sciences University, Faculty of Dentistry
Afyonkarahisar, Turkey (Tรผrkiye)
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.