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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04236115
Other study ID # Taibah dental College
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date September 20, 2017
Est. completion date June 20, 2018

Study information

Verified date January 2020
Source Taibah University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Ninety-five patients, aged between 16 and 70 years old, were included in this study. Patients were divided into two groups. Group one received Articaine 4% with 1:00.000 Adrenalines. Group two received Prilocaine with 3% Felypressin (0.03 I.U. per ml). Onset time of anaesthesia was objectively evaluated by using electronic pulp testing.


Description:

85 patients in this study had successful local anaesthetic followed by extraction within the study duration time (10 minutes). However, there were six patients with failure anaesthesia (5 in prilocaine group and 1 in articaine group). By application Person's Chi-square test (x2), there were no significant differences in the number of the episodes of the anaesthetic success between articaine and prilocaine groups at time intervals (P-value = 0.5). T- test showed there have been no important variations within the mean onset time of anaesthesia for articaine and prilocaine buccal infiltrations (P-value =0.1).


Recruitment information / eligibility

Status Completed
Enrollment 95
Est. completion date June 20, 2018
Est. primary completion date April 20, 2018
Accepts healthy volunteers No
Gender All
Age group 16 Years to 70 Years
Eligibility Inclusion Criteria:

- Patients have one or two upper teeth for extraction, subject tooth or its adjacent must be vital, healthy patient or patient with mild systemic diseases (class I or II according to American Society of Anesthesiology).

Exclusion Criteria:

- Patients excluded from this study if they have allergy to local anaesthetic agents or need surgical, or multiple teeth extraction.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Articaine 4%
Articaine 4% is dental local anaesthetic agent
Prilocain 3%
prilocaine is dental local anaesthetic agent
Adrenalin
adrenaline is a vasoconstrictor
Felypressin
Felypressin is a vasoconstrictor

Locations

Country Name City State
Saudi Arabia Taibah University Medina

Sponsors (1)

Lead Sponsor Collaborator
Taibah University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Does articaine, rather than prilocaine, increase the success rate of anaesthesia for extraction of maxillary teeth to compare the anaesthetic performances of 3% prilocaine (the safest local anaesthetic) with 4 % articaine (the local anaesthetic with fastest onset time of action) when used for maxillary teeth extraction 6 months
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