Buccal Infiltration Technique Compared to Inferior Alveolar Technique

NCT04812639 | Unknown

• 1 other identifier: BI vs IANB
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

This study was conducted to compare the efficacy of the buccal infiltration technique with inferior alveolar nerve block technique for alleviation of intraoperative pain during pulpal treatment of second mandibular primary molars using 4% Articaine 1:100000. The study started with 22 cooperative medically free patients aging 7 to 8 years old seeking treatment for bilateral deep carious mandibular second primary molars with no previous history of irreversible pulpitis, swelling, sinus tract or tooth mobility. Randomization was achieved when each candidate was instructed to pick an opaque and sealed envelope from two separate black and opaque boxes. First box contained two envelopes to identify the side on which the operator will perform the treatment. While the second box contained another two envelopes describing which anesthetic technique will be implemented with the previously chosen side. After clinical and radiographic examination, the patient received the pulpal treatment under the identified side and injecting technique. Videotaping of the pulpal treatment procedure was initiated after numbness was experienced by the child. A blind assessor was assigned to review the videos and fill in the SEM pain scale to identify the pain and level of discomfort experienced by the child during the pulpal treatment.

Conditions

Local Anesthetic Complication

Outcome Measures

Primary Outcomes (1)

• Pain during pulpal treatment

  Sound Eye Motor SEM Pain scale

  up to one month

Study Arms (2)

buccal infiltartion technique

EXPERIMENTAL

local anesthetic technique

Other: Inferior alveolar nerve block technique

Inferior alveolar nerve block technique

ACTIVE COMPARATOR

local anesthetic technique

Other: Buccal infiltration technique

Interventions

Buccal infiltration technique OTHER

a technique for injecting local anesthetic solution in the buccal mucobuccal fold between the roots of the targeted tooth

Inferior alveolar nerve block technique

Inferior alveolar nerve block technique OTHER

a technique for injecting local anesthetic solution to anesthetize the inferior alveolar nerve

buccal infiltartion technique

Eligibility Criteria

• Age: 7 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Cooperative children (rating 4 or 3 based on Frankl behavior scale) aging from 7 to 8.
• Medically free child ASA I or ASA II according to the American Society of anesthesiologist.
• Restorable bilateral deep carious lower primary second molars.
• Normal radiographic findings.

You may not qualify if:

• Uncooperative child (rating 1 or 2 on the Frankl behavior scale). 2- Signs and symptoms of irreversible pulpitis, spontaneous pain, necrosis or any signs and symptoms of abscess.
• Radiographic signs of abscess, bone loss, internal or external root resorption was evident.
• Parents or guardians refused participating in the study.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Manial, Egypt

RECRUITING

Study Officials

• Saber H Mohamed, Associate Professor

  Cairo U

  STUDY DIRECTOR

Central Study Contacts

abbas O Sherif, Master Degree holder

CONTACT

01210965669; omar_aboelabbas0107@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: not showing the anesthetic procedure in the video tape
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Study Record Dates

• First Submitted: March 14, 2021
• First Posted: March 23, 2021
• Study Start: March 1, 2021
• Primary Completion: October 1, 2022
• Study Completion: December 1, 2022
• Last Updated: August 2, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)