Comparison of Articaine and Prilocaine for Extraction of Maxillary Teeth

Sponsor

Taibah University (Other)

Overall Status

Completed

CT.gov ID

NCT04236115

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

10.6

Patients Per Site Per Month

Study Details

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

Actual Enrollment :

95 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

double blinded randomised trialdouble 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 :

Sep 20, 2017

Actual Primary Completion Date :

Apr 20, 2018

Actual Study Completion Date :

Jun 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

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

	Site	City	State	Country	Postal Code
1	Taibah University	Medina		Saudi Arabia	41311

Sponsors and Collaborators

Taibah University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Giath Gazal, Associate Professor, Taibah University

ClinicalTrials.gov Identifier:

NCT04236115

Other Study ID Numbers:

Taibah dental College

First Posted:

Jan 22, 2020

Last Update Posted:

Jan 22, 2020

Last Verified:

Jan 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Giath Gazal, Associate Professor, Taibah University

Additional relevant MeSH terms:

Felypressin

Carticaine

Study Results

No Results Posted as of Jan 22, 2020