Lower Third Molar Removal With 2% and 4% Articaine

NCT ID: NCT02457325

Last Updated: 2020-11-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2012-12-31

Brief Summary

The present clinical trial randomized compared the clinical efficacy of the local anesthetics articaine in two concentrations, 2% and 4%, in association with 1:200,000 adrenaline, for the removal of lower third molars. Onset, duration of postoperative analgesia, duration of anesthetic action on soft tissues, intraoperative bleeding, hemodynamic parameters, postoperative mouth opening and wound healing at the 7th postoperative day were evaluated. For this purpose, 50 healthy volunteers underwent removal of symmetrically positioned lower third molars, in two separate appointments (one to two months apart), under local anesthesia with either articaine 2% or 4% (both with 1:200,000 adrenaline) in a double-blind, randomized and crossed manner.

Detailed Description

The present clinical trial randomized compared the clinical efficacy of the local anesthetics articaine in two concentrations, 2% and 4%, in association with 1:200,000 adrenaline, for the removal of lower third molars. Onset, duration of postoperative analgesia, duration of anesthetic action on soft tissues, intraoperative bleeding, hemodynamic parameters, postoperative mouth opening and wound healing at the 7th postoperative day were evaluated. This study evaluated the clinical efficacy of two concentrations (2% and 4%) of the local anesthetic articaine, a local anesthetic of moderate duration, associated with adrenalin at 1: 200,000 in 50 patients aged less than 18 years and in need of extraction of the two third molars with similar positions. Evaluated the following parameters: 1) onset of action of the anesthetic agent, 2) the total amount of anesthesia used during surgery, 3) onset and duration of surgery after the administration of the local anesthetic, 4) the incidence, type and severity of adverse reactions, 5) postoperative control of mouth opening, 6) subjective evaluation of postoperative pain, 7) postoperative duration of anesthesia, 8) Total amount of relief medication and 9) heart rate and systolic and diastolic blood pressure before during and after surgery. The comparative analysis of the data and the application of proper statistical tests provided the basis for an assessment of the efficiency of both concentrations of the local anesthetic articaine (2% and 4%) with adrenalin at 1: 200,000.

Conditions

Impacted Third Molar Tooth; Adverse Reaction to Other Local Anesthetics

Keywords

Articaine; Lower third molar; Oral Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

Surgery With 2% Articaine first, then Surgery With 4%Articaine

First Intervention (1 day - third molar surgery with infiltration of one cartridge of 2% articaíne), Washout (1-2 months), and Second Intervention (1 day - third molar surgery with infiltration of one cartridge of 4% articaíne)

Group Type: EXPERIMENTAL

Surgery with 2%Articaine first, then Surgery with 4% Articaine

Intervention Type: DRUG

First Intervention (1 day - third molar surgery with infiltration of one cartridge of 2% articaíne), Washout (1-2 months), and Second Intervention (1 day - third molar surgery with infiltration of one cartridge of 4% articaíne)

Surgery With 4%Articaine first, then Surgery With 2% Articaine

First Intervention (1 day - third molar surgery with infiltration of one cartridge of 4% articaíne), Washout (1-2 months), and Second Intervention (1 day - third molar surgery with infiltration of one cartridge of 2% articaíne)

Group Type: EXPERIMENTAL

Surgery with 4%Articaine first, then Surgery with 2% Articaine

Intervention Type: DRUG

First Intervention (1 day - third molar surgery with infiltration of one cartridge of 4% articaíne), Washout (1-2 months), and Second Intervention (1 day - third molar surgery with infiltration of one cartridge of 2% articaíne)

Interventions

Surgery with 2%Articaine first, then Surgery with 4% Articaine

First Intervention (1 day - third molar surgery with infiltration of one cartridge of 2% articaíne), Washout (1-2 months), and Second Intervention (1 day - third molar surgery with infiltration of one cartridge of 4% articaíne)

Intervention Type: DRUG

Surgery with 4%Articaine first, then Surgery with 2% Articaine

First Intervention (1 day - third molar surgery with infiltration of one cartridge of 4% articaíne), Washout (1-2 months), and Second Intervention (1 day - third molar surgery with infiltration of one cartridge of 2% articaíne)

Intervention Type: DRUG

Other Intervention Names

Lower third molar with 2% Articaine and 4% Articaine; Lower third molar with 4% Articaine and 2% Articaine

Eligibility Criteria

Inclusion Criteria

• Need of lower third molar surgeries in similar positions

Exclusion Criteria

• Presence of systemic diseases;
• Presence of local inflammation and/or infection;
• Any history of allergic reaction to local anesthetics, gastrointestinal bleeding or ulceration;
• Cardiovascular and kidney diseases;
• Asthma and allergy to aspirin, piroxicam or any other non-steroidal antiinflammatory drug;
• Regular use of any non-steroidal antiinflammatory drug, pregnancy or breast feeding.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role: collaborator

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Carlos Ferreira dos Santos

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carlos F Santos, PhD

Role: PRINCIPAL_INVESTIGATOR

Bauru School of Dentistry/University of Sao Paulo

References

Senes AM, Calvo AM, Colombini-Ishikiriama BL, Goncalves PZ, Dionisio TJ, Sant'ana E, Brozoski DT, Lauris JR, Faria FA, Santos CF. Efficacy and Safety of 2% and 4% Articaine for Lower Third Molar Surgery. J Dent Res. 2015 Sep;94(9 Suppl):166S-73S. doi: 10.1177/0022034515596313. Epub 2015 Jul 22.

Reference Type: DERIVED

PMID: 26202994 (View on PubMed)

Other Identifiers

U1111-1120-3074

Identifier Type: -

Identifier Source: org_study_id