Efficacy of Buffered Versus Conventional Local Anesthesia for Reducing Pain and Anxiety During Dental Treatment in School-Aged Children Diagnosed With Pulpitis: A Randomized Controlled Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 60
- Locations
- 1
Study Overview
Brief Summary
The objective of this clinical trial is to evaluate whether buffered local anesthesia is more effective than conventional local anesthesia in reducing pain responses in school-aged children requiring dental treatment for pulpitis. The study will also assess differences in physiological and self-reported indicators of pain and anxiety, as well as anesthetic onset and duration.
The main questions it aims to answer are:
Does buffered local anesthesia reduce behavioral pain scores measured by the FLACC scale compared to conventional local anesthesia? Does buffered local anesthesia improve physiological and psychometric indicators of pain and anxiety during dental procedures?
Methodology: The researchers will compare buffered local anesthesia with conventional local anesthesia during routine dental treatment procedures such as pulpotomy or pulpectomy in primary molars.
Participants will:
Receive either buffered or conventional local anesthesia during dental treatment Undergo pulpotomy or pulpectomy depending on clinical diagnosis Be monitored for pain and anxiety using FLACC scale, heart rate, skin conductance, and Wong-Baker Faces Pain Scale at different stages of treatment Have the onset and duration of anesthesia recorded during and after the procedure Be followed until recovery of soft tissue sensation after treatment
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Participants, the treating clinician, and the outcome assessors will be blinded to group allocation. Allocation concealment will be ensured using a block randomization method.
Group assignment will be coded as Group A and Group B, and concealed in sealed, opaque containers until the end of data analysis.
Eligibility Criteria
- Ages
- 6 Years to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Children aged 6 to 12 years
- •Diagnosis of irreversible pulpitis due to dental caries in primary maxillary molars
- •American Society of Anesthesiologists (ASA) Physical Status Classification I
- •Cooperative or definitely cooperative behavior according to Frankl Behavioral Scale (Frankl III or IV)
- •Written informed consent provided by parent or legal guardian, and child assent when applicable
- •No use of analgesic or anti-inflammatory medication within 24 hours prior to the procedure
Exclusion Criteria
- •Known allergy to any component of local anesthetic solution
- •History of negative or traumatic dental experiences within the previous 12 months that may interfere with behavioral assessment
- •Radiographic evidence of periapical pathology associated with the affected tooth
- •Presence of localized abscess or acute spreading infection at the injection site
Investigators
Daniela Guzmán Uribe
Clinical Professor
Universidad Autonoma de San Luis Potosí