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Comparison of Articaine and Prilocaine for Extraction of Maxillary Teeth

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

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).

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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

Resource links provided by the National Library of Medicine


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




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



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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04236115


Locations
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Saudi Arabia
Taibah University
Medina, Saudi Arabia, 41311
Sponsors and Collaborators
Taibah University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Giath Gazal, Associate Professor, Taibah University
ClinicalTrials.gov Identifier: NCT04236115    
Other Study ID Numbers: Taibah dental College
First Posted: January 22, 2020    Key Record Dates
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)

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