Clinical trial NCT06201949: Articaine Infiltration in Anesthetizing Mandibular Second Primary Molars
Official title: Efficacy of Articaine Infiltration in Anesthetizing Mandibular Second Primary Molars During Pulpotomy Procedure (Randomized Clinical Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia, Local
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2024-01-11
Enrollment: 52
Sex: ALL
Minimum age (years): 5
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Background: Articaine hydrochloride has steadily grown in popularity, and studies have shown that articaine hydrochloride performs better than lidocaine due to an enhanced anes-thetic efficacy. The most common technique to anesthetize mandibular primary teeth is in-ferior alveolar nerve block (IANB) which induces a relatively sustained anesthesia and in turn may potentially traumatize soft-tissues. Therefore, the need of having an alternative technique of anesthesia with a shorter term but the same efficacy is reasonable.

Aim: Evaluating The effectiveness of Articaine infiltration versus conventional inferior al-veolar nerve block in anesthetizing the second primary mandibular molars during pulpoto-my procedure.

Materials and Methods: The study will be two-arm randomized controlled clinical trial, parallel design and it will be setup and reported according the CONSORT guidelines. A total of 52 healthy children aged 5-6 years, will be selected from Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Alexandria University, Egypt. Children will be selected with scores 3 or 4 according to Frankl behavioral rating scale. Each child selected will have at least one mandibular second primary molar that is indicat-ed for pulpotomy. Written informed consent will be obtained from guardian. Participants will be randomly and equally allocated to one of the two arms into two groups according to the technique of anesthesia that will be used.

Group I (Experimental group n =26) assigned to articaine infiltration anesthesia, while group II (Control group n = 26) assigned to the conventional IANB injection articaine.

Pain will be assessed by three diferent methods: physiological method using the Heart rate as vital parameter of pain, and will be recorded at base line, during injection, pulpotomy and stainless steel crown (SSC) preparation. Objective method using Sensory, Eye, Motor (SEM) scale, and subjective method where the pain will be evaluated by asking the child to express his experience using a modified face scale from the Maunuksela scale


Eligibility criteria: Inclusion Criteria:

* Positive or definitely positive behavior during preoperative assessments according to the Frankl's behavior ratings III and IV.
* Patients whose mandibular second primary molars are indicated for pulpotomy according to the AAPD.
* Patients whose parents will give their consent to participate

Exclusion Criteria:

* Children with any systemic disease or special health care.
* History of allergy to local anesthesia.
* Radiographic evidence of periapical or inter-radicular radiolucency
* Patients with previous negative dental experience.
* Presence of soft tissue lesions at the site of injection.

Primary outcomes:
measure: change in heart rate
timeFrame: During procedure
measure: change in pain level
timeFrame: During procedure
Secondary outcomes:
measure: Adevrse events
timeFrame: After 24 hours
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria Faculty of Dentistry
Study officials:
References: