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NCT Number: NCT07810452

Effect of Local Anesthesia Techniques on Pulp Hemostasis in Primary Molars

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.

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Key information

Conditions

Pulpotomies Primary Teeth

Age range

6 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Afyonkarahisar Health Sciences University, Faculty of Dentistry

Afyonkarahisar, 03030, Turkey (Türkiye)

Location status: Recruiting

Location contact

Ayça Hande Sari

CONTACT

[email protected]

+905065143594

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Inferior Alveolar Nerve Block Anesthesia

Procedure

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

Procedure

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Pain Intensity

    Time frame: Immediately after local anesthesia administration and immediately after completion of the pulpotomy procedure, during each treatment visit

    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.

  2. Heart Rate

    Time frame: Immediately before local anesthesia administration and immediately after local anesthesia administration, during each treatment visit

    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.

  3. Peripheral Oxygen Saturation (SpO₂)

    Time frame: Immediately before local anesthesia administration

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ayça Hande Sari

CONTACT

[email protected]

+905065143594

Sponsors and collaborators

Lead sponsor

Afyonkarahisar Health Sciences University

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 9, 2026
Registry last updated
Sep 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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