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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03130855
Other study ID # articaine
Secondary ID
Status Not yet recruiting
Phase N/A
First received April 2, 2017
Last updated May 8, 2017
Start date May 15, 2017
Est. completion date August 1, 2017

Study information

Verified date May 2017
Source Cairo University
Contact omar sherif abo el abbas, bachelor
Phone 01210965669
Email omarsherif15@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 48
Est. completion date August 1, 2017
Est. primary completion date July 1, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 8 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
inferior alveolar nerve block with 4% articaine
an anesthetic technique using 4% articaine anesthetic solution
buccal infiltration with 4% articaine
anesthetic technique using 4% articaine anesthetic solution

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Outcome

Type Measure Description Time frame Safety issue
Primary pain experienced by child during pulpal treatment sound-eye-motor one week
Secondary time needed for numbness stop watch one week
Secondary pain experienced by the child due to needle prick Wong Baker facial pain scale one week
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