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Compares treatment options for Pulpitis
Official title Buffered Versus Conventional Local Anesthesia for Pain and Anxiety Reduction in School-Aged Children With Pulpitis
ClinicalTrials.gov ID: NCT07638254
What this study is testing
What is Buffered Lidocaine with Epinephrine?
Buffered Lidocaine with Epinephrine is an investigational medicine, being studied as a potential treatment for pulpitis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 12. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- San Luis Potosí City, San Luis Potosí, Mexico
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 years to 12 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Luis Potosí City, San Luis Potosí, Mexico. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.