Comparison Between Efficiency of Inferior Alveolar Nerve Block and Buccal Infiltration Techniques Using Articaine 4% 1:100000

May 8, 2017 updated by: Omar Sherif Ahmed Abo El Abbas, Cairo University

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.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 8 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

A-Inclusion Criteria:

  1. first dental visit.
  2. 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.
  3. Restorable molars with stainless steel crowns.

B-Exclusion Criteria:

  1. medically compromised patients. uncooperative children (rating 1 or 2 on the Frankl behavior scale)needing special line of treatment through general anesthesia.
  2. signs and symptoms of irreversible pulpitis, spontaneous pain, necrosis or any signs or symptoms of any infection.
  3. presence of any radiographic signs of abcess, bone loss, internal or external root resorption.
  4. parents or guardians who refuse participating in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: inferior alveolar nerve block with 4% articaine
inferior alveolar nerve block using 4% articaine anesthetic solution
Drug: inferior alveolar nerve block with 4% articaine
an anesthetic technique using 4% articaine anesthetic solution
Active Comparator: buccal infiltration with 4% articaine
buccal infiltration using 4% articaine anesthetic solution
Drug: buccal infiltration with 4% articaine
anesthetic technique using 4% articaine anesthetic solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain experienced by child during pulpal treatment
Time Frame: one week
sound-eye-motor
one week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
time needed for numbness
Time Frame: one week
stop watch
one week
pain experienced by the child due to needle prick
Time Frame: one week
Wong Baker facial pain scale
one week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 15, 2017

Primary Completion (Anticipated)

July 1, 2017

Study Completion (Anticipated)

August 1, 2017

Study Registration Dates

First Submitted

April 2, 2017

First Submitted That Met QC Criteria

April 25, 2017

First Posted (Actual)

April 27, 2017

Study Record Updates

Last Update Posted (Actual)

May 10, 2017

Last Update Submitted That Met QC Criteria

May 8, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • articaine

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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