Comparison of Articaine and Prilocaine for Extraction of Maxillary Teeth

• ClinicalTrials.gov Identifier: NCT04236115
• Recruitment Status: Completed
• First Posted: January 22, 2020
• Last Update Posted: January 22, 2020
• Sponsor: Taibah University
• Information provided by (Responsible Party): Giath Gazal, Taibah University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Overcoming the Failure of Anaesthesia; Maxillary Teeth; Dental Extraction	Drug: Articaine 4%; Drug: Prilocain 3%; Drug: Adrenalin; Drug: Felypressin	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 95 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: double blinded randomised trial
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Does Articaine, Rather Than Prilocaine, Increase the Success Rate of Anaesthesia for Extraction of Maxillary Teeth
• Actual Study Start Date: September 20, 2017
• Actual Primary Completion Date: April 20, 2018
• Actual Study Completion Date: June 20, 2018

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Articaine 4% with 1:00.000 Adrenaline; 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.	Drug: Articaine 4%; Articaine 4% is dental local anaesthetic agent; Drug: Adrenalin; adrenaline is a vasoconstrictor
Active Comparator: Prilocaine with 3% Felypressin (0.03 I.U. per ml); 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.	Drug: Prilocain 3%; prilocaine is dental local anaesthetic agent; Drug: Felypressin; Felypressin is a vasoconstrictor

Outcome Measures

Primary Outcome Measures :

1. Does articaine, rather than prilocaine, increase the success rate of anaesthesia for extraction of maxillary teeth [ Time Frame: 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

Eligibility Criteria

• Ages Eligible for Study: 16 Years to 70 Years (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

Saudi Arabia

Taibah University

Medina, Saudi Arabia, 41311

Sponsors and Collaborators

Taibah University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Gazal G. Does articaine, rather than prilocaine, increase the success rate of anaesthesia for extraction of maxillary teeth. Saudi J Anaesth. 2020 Jul-Sep;14(3):297-301. doi: 10.4103/sja.SJA_94_20. Epub 2020 May 30.

• Responsible Party: Giath Gazal, Associate Professor, Taibah University
• ClinicalTrials.gov Identifier: NCT04236115
• Other Study ID Numbers: Taibah dental College
• First Posted: January 22, 2020
• Last Update Posted: January 22, 2020
• Last Verified: January 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: it will be provided on demand
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by Giath Gazal, Taibah University:

Carticaine; dental extraction; injections; prilocaine

Additional relevant MeSH terms:

Felypressin; Carticaine; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents; Vasoconstrictor Agents