NCT01742559

Brief Summary

Anesthesia of the soft and hard tissues in the maxilla may require up to five injections. Thus, the aim of the present study was to evaluate the anesthetic efficacy in buccal tissues after the use of the anterior middle superior alveolar (AMSA) and supraperiosteal techniques during subgingival scaling and root planning (SRP).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

October 30, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 5, 2012

Completed
Last Updated

December 5, 2012

Status Verified

December 1, 2012

Enrollment Period

1.6 years

First QC Date

October 30, 2012

Last Update Submit

December 2, 2012

Conditions

Keywords

Treatment

Outcome Measures

Primary Outcomes (1)

  • Assessment of Severity of Pain

    Just after the anesthetic injection the scaling and root planing procedure was performed. The patients were followed by thirty minutes after the beginning of the procedure and the patients expressed pain by placing a vertical line on a visual analogue metric scale (VAS: Visual Analog Scale).

    30 minutes after the antesthetic injection

Secondary Outcomes (1)

  • Assessment of the discomfort according to gender

    30 minutes after the antesthetic injection

Study Arms (2)

Anterior middle superior alveolar

EXPERIMENTAL

The AMSA technique was performed in the test group according to Friedman \& Hochman (1997). The needle was introduced with the bevel towards the palate tissue with a 45 ° angle and axially rotated (45° clockwise/45° counterclockwise) and 0.6 ml of the anesthetic was slowly infiltrated for 1 minute. In the control group a supraperiosteal infiltration (infiltrative) at the bottom of the vestibule was performed for one minute and 1.8 ml of anesthetic solution was administrated. This amount of anesthetic was divided into doses of 0.6 ml infiltrated, respectively, in the region of the incisors, canines and premolars. After the anesthetic technique, two minutes were expected for the beginning of the periodontal procedure.

Procedure: Anterior middle superior alveolar

Supraperiosteal technique

ACTIVE COMPARATOR

The supraperiosteal technique at the bottom of the vestibule was performed for one minute and 1.8 ml of anesthetic solution was administrated. This amount of anesthetic was divided into doses of 0.6 ml infiltrated, respectively, in the region of the incisors, canines and premolars. After the anesthetic technique, two minutes were expected for the beginning of the SRP procedure.

Procedure: Supraperiosteal technique

Interventions

The AMSA technique is performed according to Friedman \& Hochman (1997). The needle is introduced with the bevel towards the palate tissue with a 45 ° angle and axially rotated (45° clockwise/45° counterclockwise) and 0.6 ml of the anesthetic was slowly infiltrated for 1 minute. In the control group a supraperiosteal infiltration (infiltrative) at the bottom of the vestibule is performed for one minute and 1.8 ml of anesthetic solution is administrated. This amount of anesthetic is divided into doses of 0.6 ml infiltrated, respectively, in the region of the incisors, canines and premolars. After the anesthetic technique, two minutes would be expected for the beginning of the periodontal procedure.

Anterior middle superior alveolar

The supraperiosteal technique is performed at the bottom of the vestibule for one minute and 1.8 ml of anesthetic solution is administrated. This amount of anesthetic is divided into doses of 0.6 ml infiltrated, respectively, in the region of the incisors, canines and premolars. After the anesthetic technique, two minutes would be expected for the beginning of the scaling and root planning procedure.

Also known as: Infiltrative technique
Supraperiosteal technique

Eligibility Criteria

Age27 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • localized or generalized periodontal disease;
  • ≥ 3 teeth with probing depth ≥ 5 mm in anteroposterior teeth in each maxillary dental arch of the maxilla; a minimum of 6 natural teeth in the maxilla (incisors, canines and premolars);
  • good overall systemic health and absence of allergy to any component of the anesthetic used.

You may not qualify if:

  • Patients who had any type of systemic condition that counter indicated periodontal treatment;
  • Patients who had taken, within the last 72 hours prior to procedure, any central nervous system depressant, such as alcohol, non-opioid and opioid.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

State University of Maringá

Maringá, Paraná, 87020-000, Brazil

Location

MeSH Terms

Conditions

Periodontal DiseasesPain

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Maurício Araújo, PhD

    State University of Maringá

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
The anesthetic effect of anterior middle superior alveolar technique (AMSA) for non-surgical periodontal procedures: a randomized controlled clinical study

Study Record Dates

First Submitted

October 30, 2012

First Posted

December 5, 2012

Study Start

January 1, 2009

Primary Completion

August 1, 2010

Study Completion

July 1, 2011

Last Updated

December 5, 2012

Record last verified: 2012-12

Locations