Lower Third Molar Removal With 2% and 4% Articaine

NCT02457325 | Completed Phase 4 Results DMC

• 1 other identifier: U1111-1120-3074
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Impacted Third Molar Tooth; Adverse Reaction to Other Local Anesthetics

Keywords

Articaine; Lower third molar; Oral Surgery

Outcome Measures

Primary Outcomes (6)

• Onset of Anesthetic

  Onset of anesthetic agent action, as determined by the loss of sensibility of the inferior lip, the corresponding half of the tongue, and the mucosa as reported by the patient.

  During the surgical procedure, an average of 30 minutes

• Quality of Anesthesia

  Quality of anesthesia during surgery based on a category 3-point scale: 1) the patient reported no discomfort; 2) the patient reported discomfort, without the need to supplement the anesthesia; 3) reported some discomfort by the patient, requiring anesthesia complementation. Intraoral bleeding that will be evaluated by the surgeon according to a 3-point scale (1: minimal, 2: normal and 3: Maximum), immediately after the following steps: injection of the first cartridge anesthesia, incision, mucoperiosteal detachment, osteotomies, tooth section, extraction, cleaning and suturing.

  During the surgical procedure, an average of 30 minutes

• Intraoperative Bleeding

  Intraoperative bleeding, rated by the surgeon according to a 3-point category rating scale (1-minimal bleeding; 2-normal bleeding; 3-excessive bleeding) (SISK, 1986), immediately after the following steps: injection of the first cartridge of articaine, tissue incision, flap reflection, bone removal (when this procedure was necessary), tooth extraction, cleaning of the operated site, and completion of suturing.

  During the surgical procedure, an average of 30 minutes

• Blood Pressure

  mean blood pressure was verified and recorded at surgical moments previously described (injection of the first cartridge anesthesia, incision, mucoperiosteal detachment, osteotomies, tooth section, extraction, cleaning and suturing), carried out with the aid of a system for monitoring hemodynamic parameters.

  During the surgical procedure, an average of 30 minutes

• Heart Rate

  Heart rate to be verified and recorded surgical at moments described above, carried out with the aid of a system for monitoring hemodynamic parameters.

  During the surgical procedure, an average of 30 minutes

• Oxygen Saturation

  Oxygen saturation to be verified and recorded at surgical moments described above, carried out with the aid of a system for monitoring hemodynamic parameters.

  During the surgical procedure, an average of 30 minutes

Secondary Outcomes (5)

• Duration of Post-operative Analgesia

  During the day of the surgery, 24 hours

• Postoperative Mouth Opening

  Seventh postoperative days

• Wound Healing of the Operated Area

  Seventh postoperative day

• Evaluation of Post-surgical Pain

  Seventh postoperative day

• Postoperative Anesthesia

  During the day of the surgery

Study Arms (2)

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

EXPERIMENTAL

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)

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

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

EXPERIMENTAL

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)

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

Interventions

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

Also known as: Lower third molar with 2% Articaine and 4% Articaine

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

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

Also known as: Lower third molar with 4% Articaine and 2% Articaine

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

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Need of lower third molar surgeries in similar positions

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Related Publications (1)

• 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.

  PMID: 26202994 DERIVED

MeSH Terms

Interventions

Surgical Procedures, Operative; Carticaine

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Carlos Ferreira Santos
• Organization: University of Sao Paulo / Bauru School of Dentistry

cfsantos@fob.usp.br

+551432358200

Study Officials

• Carlos F Santos, PhD

  Bauru School of Dentistry/University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: May 18, 2015
• First Posted: May 29, 2015
• Study Start: June 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: November 24, 2020
• Results First Posted: November 24, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share