Comparison of Articaine and Prilocaine for Extraction of Maxillary Teeth

NCT04236115 | Completed Phase 4

• 1 other identifier: Taibah dental College
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

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.

Conditions

Overcoming the Failure of Anaesthesia; Maxillary Teeth; Dental Extraction

Keywords

Carticaine; dental extraction; injections; prilocaine

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Articaine 4% with 1:00.000 Adrenaline

ACTIVE COMPARATOR

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%; Drug: Adrenalin

Prilocaine with 3% Felypressin (0.03 I.U. per ml)

ACTIVE COMPARATOR

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%; Drug: Felypressin

Interventions

Articaine 4% DRUG

Articaine 4% is dental local anaesthetic agent

Articaine 4% with 1:00.000 Adrenaline

Prilocain 3% DRUG

prilocaine is dental local anaesthetic agent

Prilocaine with 3% Felypressin (0.03 I.U. per ml)

Adrenalin DRUG

adrenaline is a vasoconstrictor

Articaine 4% with 1:00.000 Adrenaline

Felypressin DRUG

Felypressin is a vasoconstrictor

Prilocaine with 3% Felypressin (0.03 I.U. per ml)

Eligibility Criteria

• Age: 16 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Taibah University: lead

Study Sites (1)

Taibah University

Madinah, 41311, Saudi Arabia

Location

Related Publications (1)

• 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.

  PMID: 32934619 DERIVED

MeSH Terms

Interventions

Epinephrine; Felypressin

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Lypressin; Vasopressins; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: double blinded randomised trial

Study Record Dates

• First Submitted: January 15, 2020
• First Posted: January 22, 2020
• Study Start: September 20, 2017
• Primary Completion: April 20, 2018
• Study Completion: June 20, 2018
• Last Updated: January 22, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

SA (1)