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Comparison of the anesthetic efficacy of alkalized lidocaine with non-alkalized lidocaine in infiltration injection of maxillary primary molars

Comparison of the anesthetic efficacy of alkalized lidocaine with non-alkalized lidocaine in infiltration injection of maxillary primary molars: a randomized clinical trial.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20240511061732N1
Enrollment
25
Registered
2024-05-18
Start date
2024-06-13
Completion date
Unknown
Last updated
2024-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Introducing and proposing a more effective anesthetic solution with less pain to relieve pain during the pulp treatment of children's teeth.

Interventions

Intervention 1: Intervention group: Alkalized lidocaine is used in the intervention group. To alkalize lidocaine 2% (Daropakhsh-Iran) together with adrenaline 80000: 1, with sodium bicarbonate, 0.18 m

Sponsors

Yazd University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
7 Years to 11 Years

Inclusion criteria

Inclusion criteria: 7-11-year-old children referred to the children's department of the Faculty of Dentistry who need pulp treatment of primary molar teeth on both sides of the maxilla. According to the report of the parents, the children are healthy and do not have systemic diseases (hepatic, blood, kidney and digestive). Children have not used analgesics on the day of treatment. Children do not have learning disabilities and understand Persian language well.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Onset of action of anesthesia. Timepoint: After injection of anesthesia. Method of measurement: The onset of the effect of local anesthesia with the elapsed time in seconds will be recorded by the performing dentist. From the time the local anesthesia is administered until the child feels tingling or numbness of the lips, tongue and corner of the lips (subjective symptoms) and does not feel pain during the probe (objective symptoms) will be recorded as the time of the onset of anesthesia effectiveness.

Secondary

MeasureTime frame
Intensity of pain during anesthesia injection. Timepoint: During anesthetic injection. Method of measurement: For the objective evaluation of pain during anesthetic injection using the Wong-Baker FACES pain rating scale, for the subjective evaluation of pain during injection using the Sound scale; Eyes; Motor is used.;Average blood oxygen level. Timepoint: Immediately before injection and five minutes after injection. Method of measurement: By pulse oximeter.;Average number of pulse beats. Timepoint: Immediately before injection and five minutes after injection. Method of measurement: By pulse oximeter.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactZahra Amiri Simkooei

Yazd University of Medical Sciences

z.amirisimkooei@stu.ssu.ac.ir+98 939 249 2726

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026