Effect of Local Anesthesia Techniques on Pulp Hemostasis in Primary Molars

NCT07810452 · tracked via the Priya Life Science Turkey tracker

Sponsor

Afyonkarahisar Health Sciences University

Phase

Not applicable

Started

2026-04-15

Last updated

2026-09-14

Condition(s) studied

Pulpotomies Primary Teeth

Investigational drug(s) / intervention(s)

Inferior Alveolar Nerve Block AnesthesiaComputer-Controlled Intraosseous Anesthesia

Inferior Alveolar Nerve Block Anesthesia: 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 Anesthesia: 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 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.

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.

Eligibility

Sex

ALL

Min age

6 Years

Max age

9 Years

Healthy volunteers

Accepted

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.

Primary outcome measure(s)

Pulp Hemostasis Time — 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.

Trial sites (1)

Facility	City	Region	Status
Afyonkarahisar Health Sciences University, Faculty of Dentistry	Afyonkarahisar	Afyonkarahisar	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07810452 on ClinicalTrials.gov ↗ ← All trials in Turkey