Articaine Infiltration in Anesthetizing Mandibular Second Primary Molars

Not Applicable

Completed

• Conditions: Anesthesia, Local
• Interventions: Other: Articaine nerve block technique; Other: Articaine infiltration technique

• Registration Number: NCT06201949
• Lead Sponsor: Hams Hamed Abdelrahman

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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-16
• Primary Completion: 2023-06-18
• Study Completion: 2023-06-30
• Status Verified: 2024-01
• Study First Submitted: 2024-01-01
• Study First Submitted QC: 2024-01-01
• Last Update Submitted: 2024-01-01
• Study First Posted: 2024-01-11
• Last Update Posted: 2024-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Articaine nerve block technique	-
Test group	Articaine infiltration technique	-

Primary Outcome Measures

Name	Time	Method
change in heart rate	During procedure	Heart rate (HR) is a physiological sign of pain.(30) It will be measured using a pulse oximeter.
change in pain level	During procedure	Sound, Eye, Motor (SEM) Scale(31) (Appendix III), will used as an ob-jective method for pain assessment during LA administration, pulpo-tomy and SSC. It comprises the following parameters: (1) Sound, (2) Eye, (3) Motor. For each child, the sounds, eye symptoms and body movements will be evaluated independently by a blind impartial ob-server using the recorded video tapes. The slightest manifestation of the sound, eyes, or motion of the patient is graded in four levels: com-fort, mild, moderate, and severe discomfort, and subsequently given grades 1, 2, 3, 4, respectively. SEM score will be calculated by sum-ming the three grades of the parameters.

Secondary Outcome Measures

Name	Time	Method
Adevrse events	After 24 hours	The presence of any adverse events including infection, oral/tooth pain, patients will be seen after 24 hours to detect any lip/cheek biting and parasethia

Trial Locations

Locations (1)

Alexandria Faculty of Dentistry; 🇪🇬 Alexandria, Egypt