Assessment of Anesthetic Efficacy and Hemodynamic Stability of Two LA Drugs for Hypertensive Patients

NCT06927726 | Enrolling By Invitation

• 1 other identifier: 4-2025
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Pain control in dentistry is an important factor for reducing the fear and anxiety associated with dental procedures. For tooth extraction, it is mandatory to use resources to manage pain and discomfort such as adequate anesthetic techniques . Patient's systemic health conditions and type of local anesthetic drug used, in addition to duration and extension of the extraction procedure are factors which can influence the management of pain in tooth extractions . Tooth extractions can cause morbidity and changes in hemodynamic parameters to the patient; therefore, it is paramount to carefully select a local anesthetic drug to minimize adverse events . There are a variety of local anesthetics drugs which can meet the specific requirements of different clinical procedures, among them 4% articaine chloridrate with epinephrine at a ratio of 1:100,000. and with and 3% mepivacaine chloridrate without epinephrine, which are largely used in the dental practice and whose clinical safety has already been tested and proved elsewhere

Conditions

Hypertension

Keywords

hemodynamic stability; hypertensive patients; local anesthetic drugs

Outcome Measures

Primary Outcomes (4)

• Visual analog scale

  0 represent no pain and 10 represenet severe pain

  1 hour

• systolic (SBP) and diastolic blood pressure

  normal 120/80

  1 hour

• heart rate

  normal 70

  1 hour

• oxygen saturation

  normal 95-98

  1 hour

Study Arms (2)

4% articaine (1:100,000 epinephrine)

ACTIVE COMPARATOR

Local maxillary infiltration anesthesia adjacent to the tooth with extraction will be the anesthetic method used throughout by a vestibular (1.5 ml) and a palatal injection (0.3 ml). The following agents will be applied for anesthetization: Septanest 4% Articaine HCL With 1:100,000 Epinephrine The injections and the extractions will be performed by certified dentists of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Tanta University. Dental extraction will be performed after full anesthesia, tested with a probe on the buccal mucosa, palatal mucosa, and the tooth itself each minute after injection, and after subjective symptoms of numbness by the patient.

Drug: 4% Articaine HCL With 1:100,000 Epinephrine

3% mepivacaine

ACTIVE COMPARATOR

Local maxillary infiltration anesthesia adjacent to the tooth with extraction will be the anesthetic method used throughout by a vestibular (1.5 ml) and a palatal injection (0.3 ml). The following agents will be applied for anesthetization: Scandonest 3% plain mepivacaine HCL (Septodont, Manufactured By Novocol Pharmaceuticals of Canada). The injections and the extractions will be performed by certified dentists of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Tanta University. Dental extraction will be performed after full anesthesia, tested with a probe on the buccal mucosa, palatal mucosa, and the tooth itself each minute after injection, and after subjective symptoms of numbness by the patient.

Drug: 3% plain mepivacaine HCL

Interventions

4% Articaine HCL With 1:100,000 Epinephrine DRUG

Preoperative clinically and radiographic examination will be performed for each patient. Local maxillary infiltration anesthesia adjacent to the tooth with extraction will be the anesthetic method used throughout by a vestibular (1.5 ml) and a palatal injection (0.3 ml). The following agents will be applied for anesthetization: Septanest 4% Articaine HCL With 1:100,000 Epinephrine. The injections and the extractions will be performed by certified dentists of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Tanta University. Dental extraction will be performed after full anesthesia, tested with a probe on the buccal mucosa, palatal mucosa, and the tooth itself each minute after injection, and after subjective symptoms of numbness by the patient.

Also known as: Septanest

4% articaine (1:100,000 epinephrine)

3% plain mepivacaine HCL DRUG

Preoperative clinically and radiographic examination will be performed for each patient. Local maxillary infiltration anesthesia adjacent to the tooth with extraction will be the anesthetic method used throughout by a vestibular (1.5 ml) and a palatal injection (0.3 ml). The following agents will be applied for anesthetization: Scandonest 3% plain mepivacaine HCL (Septodont, Manufactured By Novocol Pharmaceuticals of Canada). The injections and the extractions will be performed by certified dentists of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Tanta University. Dental extraction will be performed after full anesthesia, tested with a probe on the buccal mucosa, palatal mucosa, and the tooth itself each minute after injection, and after subjective symptoms of numbness by the patient.

Also known as: Scandonest

3% mepivacaine

Eligibility Criteria

• Age: Up to 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• patients in need of single tooth extraction owing to caries and/or periodontitis in the maxilla, with controlled hypertension with blood pressure not exceeding values of 160/100 mm Hg

You may not qualify if:

• patients with systemic health problems (e.g uncontrolled hypertension, unstable angina pectoris
• recent myocardial infarct (6 months)
• refractory dysrhythmias
• untreated or uncontrolled congestive heart failure)
• uncontrolled diabetes mellitus
• history of allergic reactions to anesthetics drugs
• Pregnancy or breastfeeding
• Patients requiring open surgical extractions or with infected teeth

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

faculty of dentistry, Tanta university

Tanta, Tanta, 31111, Egypt

Location

MeSH Terms

Conditions

Hypertension

Interventions

Carticaine; Epinephrine; Mepivacaine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ethanolamines; Amino Alcohols; Alcohols; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperidines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: April 15, 2025
• Study Start: January 10, 2025
• Primary Completion: February 10, 2025
• Study Completion: December 10, 2025
• Last Updated: November 18, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)