Comparison Between Efficiency of Inferior Alveolar Nerve Block and Buccal Infiltration Techniques Using Articaine 4% 1:100000
Buccal Infiltration Technique Compared to Inferior Alveolar Nerve Block Technique for Alleviation of Intraoperative Pain During Pulpal Treatment of Mandibular Primary Molars: A Randomized Controlled Clinical Trial.
1 other identifier
interventional
48
0 countries
N/A
Brief Summary
This split mouth randomized control trial is designed as to compare the effectiveness of the buccal infiltration technique with the gold standard inferior alveolar nerve block in anesthetizing mandibular second primary molars to undergoing pulpal treatment. patient will be videotaped during pulpal treatment of their teeth and an accessing pain will be through an objective pain scale (SEM scale), (sound-eye-motor scale). the patient will be asked to fill in a subjective Wong Baker pain scale for the pain suffered during injecting the local anesthetic agent in both techniques.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2017
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 2, 2017
CompletedFirst Posted
Study publicly available on registry
April 27, 2017
CompletedStudy Start
First participant enrolled
May 15, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2017
CompletedMay 10, 2017
May 1, 2017
2 months
April 2, 2017
May 8, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
pain experienced by child during pulpal treatment
sound-eye-motor
one week
Secondary Outcomes (2)
time needed for numbness
one week
pain experienced by the child due to needle prick
one week
Study Arms (2)
inferior alveolar nerve block with 4% articaine
EXPERIMENTALinferior alveolar nerve block using 4% articaine anesthetic solution
buccal infiltration with 4% articaine
ACTIVE COMPARATORbuccal infiltration using 4% articaine anesthetic solution
Interventions
an anesthetic technique using 4% articaine anesthetic solution
anesthetic technique using 4% articaine anesthetic solution
Eligibility Criteria
You may qualify if:
- first dental visit.
- cooperative children (rating 4 or 3 based on Frankl behavior scale) aging from 6 to 8 years suffering from one or more deep carious lesions in their primary molars seeking treatment.
- Restorable molars with stainless steel crowns.
You may not qualify if:
- medically compromised patients. uncooperative children (rating 1 or 2 on the Frankl behavior scale)needing special line of treatment through general anesthesia.
- signs and symptoms of irreversible pulpitis, spontaneous pain, necrosis or any signs or symptoms of any infection.
- presence of any radiographic signs of abcess, bone loss, internal or external root resorption.
- parents or guardians who refuse participating in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- resident at pediatric dentistry and public health faculty of oral and dental medicine cairo university
Study Record Dates
First Submitted
April 2, 2017
First Posted
April 27, 2017
Study Start
May 15, 2017
Primary Completion
July 1, 2017
Study Completion
August 1, 2017
Last Updated
May 10, 2017
Record last verified: 2017-05
Data Sharing
- IPD Sharing
- Will not share