Comparison of Articaine and Prilocaine for Extraction of Maxillary Teeth

Phase 4

Completed

• Conditions: Overcoming the Failure of Anaesthesia; Maxillary Teeth; Dental Extraction
• Interventions: Drug: Articaine 4%; Drug: Prilocain 3%; Drug: Adrenalin; Drug: Felypressin

• Registration Number: NCT04236115
• Lead Sponsor: Taibah University

Brief 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.

Detailed 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).

Study Timeline

• Study Start: 2017-09-20
• Primary Completion: 2018-04-20
• Study Completion: 2018-06-20
• Status Verified: 2020-01
• Study First Submitted: 2020-01-15
• Study First Submitted QC: 2020-01-21
• Last Update Submitted: 2020-01-21
• Study First Posted: 2020-01-22
• Last Update Posted: 2020-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 95

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Articaine 4% with 1:00.000 Adrenaline	Articaine 4%	if the patient was in articaine group, buccal infiltration technique was applied by inserting a short needle at the height of buccal sulcus along the long axis of the subject tooth for extraction.
Prilocaine with 3% Felypressin (0.03 I.U. per ml)	Prilocain 3%	if the patient was in prelocaine group, buccal infiltration technique was applied by inserting a short needle at the height of buccal sulcus along the long axis of the subject tooth for extraction.
Articaine 4% with 1:00.000 Adrenaline	Adrenalin	if the patient was in articaine group, buccal infiltration technique was applied by inserting a short needle at the height of buccal sulcus along the long axis of the subject tooth for extraction.
Prilocaine with 3% Felypressin (0.03 I.U. per ml)	Felypressin	if the patient was in prelocaine group, buccal infiltration technique was applied by inserting a short needle at the height of buccal sulcus along the long axis of the subject tooth for extraction.

Primary Outcome Measures

Name	Time	Method
Does articaine, rather than prilocaine, increase the success rate of anaesthesia for extraction of maxillary teeth	6 months	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

Trial Locations

Locations (1)

Taibah University; 🇸🇦 Medina, Saudi Arabia