Dental Anesthesia in Pregnant Women With Rheumatic Heart Disease

NCT00482573 | Completed Phase 1 DMC

• 1 other identifier: CAPPesq 009/03
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

The hemodynamic parameters of 31 pregnant women with rheumatic valve disease, undergoing restorative dentistry under local anesthesia with 2% solution of lidocaine, divided in two groups, with (Group LE) and without 1:100,000 epinephrine solution (Group LNE), were studied by 24-hour ambulatory electrocardiographic monitoring, intermittent blood pressure monitoring and continuous cardiotocography, during three standard time periods. A significant decrease in the values of maternal heart rate was seen during the procedure, in comparison with the other two time periods in the two groups, as well as, the occurrence of cardiac arrhythmia in 9 (29.1%) patients, being 7 (41.8%) of them in the group receiving epinephrine anesthesia. We conclude the use of 2% lidocaine in association with epinephrine proved safe during dental procedure in pregnant women with rheumatic valve disease.

Conditions

Rheumatic Heart Disease; Pregnancy; Dental Caries

Keywords

Electrocardiography, ambulatory/methods; Blood Pressure monitoring, ambulatory/methods; Cardiotocography/methods; Dental restoration, permanent; Anesthesia, local /methods; Lidocaine; Vasoconstrictor Agents; Epinephrine; Pregnancy; Rheumatic Heart Disease

Outcome Measures

Primary Outcomes (1)

• Maternal: Blood Pressure, Heart Rate and Extrasystoles; Maternal-Fetal: Fetal Heart Rate, number of uterine contractions, motility and fetal reactivity pattern, in function of presence or not of epinephrine 1:100000 in the 2% solution.of lidocaine

  4 periods Maternal: (1) Baseline - 60 minutes before the procedure, (2) Procedure, (3) Post-Procedure - 20 minutes, and (4) mean 24-hour; 3 periods Maternal-Fetal: (1) Baseline: 20 minutes before, (2) Procedure, and (3) Post-Procedure - idem maternal

Secondary Outcomes (1)

• They had been the same analyses used for the Primary Outcome Measures, in function of the gestational age (GA): sub-group GA1 (15 pregnant women between 28 and 31 weeks) and sub-group GA2 (16 pregnant women between 28 and 31 weeks).

  They had been the same periods established for the Time Frame of Primary Outcome Measure

Study Arms (2)

Group LE

EXPERIMENTAL

Seventeen (54.8%) patients, composed group LE, were randomly assigned for the infusion of 1.8 mL (one cartridge) by the modified anesthesia into the periodontal ligament (PDLm injection) of 2% lidocaine solution with epinephrine 1:100,000. Their ages were ranging from 18 to 44 years (mean:29.6), they were diagnosed as having rheumatic valve disease, in a functional class I or II according to classification of the NYHA. Gestation age ranged from 28 to 36 weeks (mean:31.8), and the BMI from 18.7 to 32.9 (mean:23.8) kg/m2. All the patients had the restauration done in their inferior premolar and/or molar teeth.

Procedure: Dental local anesthesia

Group LNE

ACTIVE COMPARATOR

Fourteen (45.2%) patients, composed group LNE, were randomly assigned for the infusion of 1.8 mL (one cartridge) by the modified anesthesia into the periodontal ligament (PDLm injection) of 2% lidocaine solution without epinephrine. Their ages were ranging from 22 to 33 years (mean:26.6), they were diagnosed as having rheumatic valve disease, in a functional class I or II according to classification of the NYHA. Gestation age ranged from 29 to 37 weeks (mean:32.1), and the BMI from 18.5 to 38.1 (mean:22.8) kg/m2. All the patients had the restauration done in their inferior premolar and/or molar teeth.

Procedure: Dental local anesthesia

Interventions

Dental local anesthesia PROCEDURE

* 2% lidocaine solution with epinephrine 1:100,000 * infusion of 1,8 mL (one cartridge) * Technic: modified anesthesia of the periodontal ligament (PDLm injection) was performed applying The Wand II Computerized System (Milestone International)

Also known as: Alphacaine® 2% with epinephrine 1:100,000 - DFL, - fab/man 06/2003 - val/exp 06/2005 - lot 0306D11 and, - fab/man 04/2004 - val/exp 04/2006 - lot 0404D05

Group LE

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical criteria: women with rheumatic valvar disease as diagnosed by the clinical history and physical examination, and documented by Doppler echocardiography, either having undergone surgical or percutaneous intervention before becoming pregnant or not, in functional class (FC) I or II, according to classification of the New York Heart Association (NYHA).
• Obstetrical criteria: one fetus pregnancy, gestational age (GA) between 28 and 37 weeks.
• Odontological criteria: total or partial dentition, with the presence of lower premolar and/or molar teeth in need of restorative dentistry due to development of dental caries (Black Class I, II and/or V), or due to the presence of restorations with edge infiltration clinically and/or radiographically diagnosed recurrent caries.

You may not qualify if:

• Clinical criteria: heart failure, uncontrolled chronic arterial hypertension, or complex and/or symptomatic ventricular arrhythmia.
• Obstetrical criteria: preeclampsia, uterine growth restriction, and labor.
• Odontological criteria: dental caries in lower premolar or molar tooth with clinical and/or radiographic diagnosis of pulpal exposure, pulpitis, or pulpal necrosis, fracture or destruction of the tooth crown with prognostic of endodontic treatment or rehabilitation by prosthesis, or indication for extraction.
• Psychiatric criteria: patients with anxiety disorders such as panic, agoraphobia, social or specific phobias and obsessive-compulsive disorders, posttraumatic stress, or chemically-induced anxiety, according to the classification of the American Psychiatric Association (APA).

Sponsors & Collaborators

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

Study Sites (1)

Heart Institute (InCor) of University of São Paulo Medical School

São Paulo, São Paulo, SP 05403-000, Brazil

Location

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Related Links

• One is about a InterNet Portal where it is possible to have access teses in the complete one, defended in all the University of Sao Paulo.

MeSH Terms

Conditions

Rheumatic Heart Disease; Dental Caries

Interventions

Epinephrine

Condition Hierarchy (Ancestors)

Rheumatic Fever; Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Heart Diseases; Cardiovascular Diseases; Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Itamara LI Neves, PhD

  Heart Institute (InCor) of University of São Paulo Medical School - Sao Paulo, Brazil

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 4, 2007
• First Posted: June 5, 2007
• Study Start: April 1, 2004
• Primary Completion: July 1, 2005
• Study Completion: January 1, 2006
• Last Updated: June 5, 2008

Record last verified: 2008-06

Locations

BR (1)