Effect of Local Anesthesia Techniques on Pulp Hemostasis in Primary Molars
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:
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 Overview
Status
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ayça Hande Sari
- Phone Number: +905065143594
- Email: aycahande94@gmail.com
Study Locations
-
-
Afyonkarahisar
-
Afyonkarahisar, Afyonkarahisar, Turkey (Türkiye), 03030
- Recruiting
- Afyonkarahisar Health Sciences University, Faculty of Dentistry
-
Contact:
- Ayça Hande Sari
- Phone Number: +905065143594
- Email: aycahande94@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: IANB Followed by Intraosseous Anesthesia
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.
|
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 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
|
|
Experimental: Intraosseous Anesthesia Followed by IANB
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.
|
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 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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
During pulpotomy, up to 5 minutes after coronal pulp removal
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Intensity
Time Frame: Immediately after local anesthesia administration and immediately after completion of pulpotomy
|
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.
|
Immediately after local anesthesia administration and immediately after completion of pulpotomy
|
|
Heart Rate
Time Frame: Immediately before and after local anesthesia administration
|
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.
|
Immediately before and after local anesthesia administration
|
|
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.
|
Immediately before local anesthesia administration
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 26.GENEL.013
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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