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Dental Anesthesia in Pregnant Women With Rheumatic Heart Disease

Primary Purpose

Rheumatic Heart Disease, Pregnancy, Dental Caries

Status
Completed
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
Dental local anesthesia
Dental local anesthesia
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatic Heart Disease focused on measuring Electrocardiography, ambulatory/methods, Blood Pressure monitoring, ambulatory/methods, Cardiotocography/methods, Dental restoration, permanent, Anesthesia, local /methods, Lidocaine, Vasoconstrictor Agents, Epinephrine, Pregnancy, Rheumatic Heart Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group LE

Group LNE

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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).

Full Information

First Posted
June 4, 2007
Last Updated
June 4, 2008
Sponsor
University of Sao Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT00482573
Brief Title
Dental Anesthesia in Pregnant Women With Rheumatic Heart Disease
Official Title
Maternal-Fetal Monitoring of Patients With Rheumatic Heart Disease During Dental Procedure Under Local Anesthesia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
July 2005 (Actual)
Study Completion Date
January 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Sao Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
During pregnancy, the organic systems of a woman are subjected to physiological modifications consequential to hormonal, anatomic and metabolical alterations. The most significant modification in the circulatory system is an increased cardiac output from the first three months of gestation. Women with heart disease may present with severe complications during the gestational period, because of inappropriate adaptation of her body to this hemodynamic overload, even those patients who are thought to have an appropriate functional capacity during early pregnancy. There are scant studies in the literature on the effects of local anesthetics, with and without vasoconstrictor, used in dental procedures on the cardiovascular variables of pregnant women with valvar disease, as well as on their concepti. Driven by this shortage, we decided to have this subject studied, by assessing and analyzing cardiotocographic parameters, such as fetal heart rate (FHR), fetal motility(FM) and uterine contractions (UC), in addition to blood pressure (BP) and electrocardiographic variables, such as heart rate (HR) and extrasystoles (ES), in pregnant women with rheumatic valvar disease who undergo local anesthesia with lidocaine, with and without vasoconstrictor, during restorative dental procedure. For this, 31 rheumatic heart disease patients who were in their 28th to 37th week of gestation, had 24-hour ambulatory monitoring of their BP and Holter electrocardiography (Holter-ECG), and cardiotocography (CTG), performed during: (1) baseline - 60 minutes before the procedure for BP and Holter-ECG monitoring, and 20 minutes before the procedure for CTG; (2) procedure - 56±15.5 minutes (mean±SD); (3) post-procedure - 20 minutes; and (4) mean 24-hour HR and ES measurement, and mean wake and sleeping periods BP monitoring. Variation of the above variables was analyzed in two groups, one with infusion of a 2% solution of lidocaine without vasoconstrictor (Group LNE) composed of 14 patients, and the other with infusion of a 2% solution of lidocaine with epinephrine 1:100,000 (Group LE) composed of 17 patients, randomized drawing and single blind. The investigator wise person which solution of lidocaine was being used, therefore the proper local vasoconstriction denounced if it was infiltrated or not epinephrine. The used technique was of the modified periodontal ligament (PDLm injection), by means of the equipment The Wand, infusing 1.8 ml (one cartridge) in six minutes. We use the technique of analysis of variance (ANOVA) with repeated measures to calculate the size of the sample and for the analysis and multiple interpretation of the variable in three distinct periods, on the basis of the table of Vonesh and Shork (15 patients in each group, considering a correlation enters the measures of next value the 0,4, a level of significance of 5% and to be able of test of 80%). All the variable had been initially analyzed descriptive. For the quantitative variable this analysis was made through the comment of the minimum and maximum values, and of the calculation of medium averages and shunting line-standard and. For the qualitative variable we calculate absolute and relative frequencies. The level of significance used for the tests was of 5% (p<0,05).The maternal HR values obtained during the procedure showed a significant reduction only in comparison with the other time periods (P<0.001)in the two groups. The comparison of the groups LE e LNE did not reveal any significant difference (P>0.05). ES was detected in 9 (29.0%) patients, being 7 of them (41.8%) from the Group LE. BP did not show any significant difference neither between time periods, nor between groups (P>0.05). The same occurred in the comparative analysis of the fetal parameters obtained during CTG - number of UC, level and variability from baseline of the FHR, number of accelerations of the FHR and fetal reactivity pattern. Our conclusion was that the use of 2% solution of lidocaine in association with epinephrine proved safe during dental procedure in pregnant women with rheumatic valvar cardiopathy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group LE
Arm Type
Experimental
Arm Description
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.
Arm Title
Group LNE
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Dental local anesthesia
Other Intervention Name(s)
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
Intervention Description
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)
Intervention Type
Procedure
Intervention Name(s)
Dental local anesthesia
Other Intervention Name(s)
Xylestesin® 2% without vasoconstrictor - Cristália, - fab/man 06/2003 - val/exp 06/2006 - lot 3062010
Intervention Description
2% lidocaine solution without vasoconstrictor 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)
Primary Outcome Measure Information:
Title
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
Time Frame
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 Outcome Measure Information:
Title
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).
Time Frame
They had been the same periods established for the Time Frame of Primary Outcome Measure

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Itamara LI Neves, PhD
Organizational Affiliation
Heart Institute (InCor) of University of São Paulo Medical School - Sao Paulo, Brazil
Official's Role
Principal Investigator
Facility Information:
Facility Name
Heart Institute (InCor) of University of São Paulo Medical School
City
Sao Paulo
ZIP/Postal Code
SP 05403-000
Country
Brazil

12. IPD Sharing Statement

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Dental Anesthesia in Pregnant Women With Rheumatic Heart Disease

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