Dental Anesthesia in Pregnant Women With Rheumatic Heart Disease
Rheumatic Heart Disease, Pregnancy, Dental Caries
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
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
Experimental
Active Comparator
Group LE
Group LNE
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.