HypertensionNCT06927726
Assessment of Anesthetic Efficacy and Hemodynamic Stability of Two LA Drugs for Hypertensive Patients
A study testing 4% Articaine HCL With 1:100,000 Epinephrine and 3% plain mepivacaine HCL in people with Hypertension, run by Tanta University at 1 site in Egypt.
Trial 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 . Read more about this study
- Who is it for?
- Ages Up to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- 4% Articaine HCL With 1:100,000 Epinephrine and 3% plain mepivacaine HCL
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jan 2025to 10 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Assessment of Anesthetic Efficacy and Hemodynamic Stability of 4% Articaine (1:100,000 Epinephrine) Versus 3% Mepivacaine Used in Maxillary Teeth Extraction for Hypertensive Patients: A Double-blind Randomized Clinical Study
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
Read the detailed description
The aim of this prospective study is to compare the anesthetic efficacy and hemodynamic parameters of 4% articaine chloridrate with epinephrine (1:100,000) versus 3% mepivacaine chloridrate without epinephrine in maxillary infiltration for teeth extraction of in controlled hypertensive patients.
Material and Methods The main inclusion criteria for this prospective, randomized, double-blinded clinical study will be 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. The exclusion criteria will be 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, and Patients requiring open surgical extractions or with infected teeth were excluded from the study Patients will be selected from Oral and Maxillofacial Surgery Department, Faculty of Dentistry. Tanta University. Equal randomization was achieved with the use of a computer-generated random number list, and signed inform consent will be obtained from every patient included in the study.
Power calculation A study with sixty subjects is reported to have 90% power to detect a difference in success rate of 21% in a continuous outcome measure assuming a significance level of 5% and a correlation of 0.5 between responses from the same subject.
Anaesthetic administration 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 and 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.
Outcome measures of anesthetic success Successful pulp anesthesia is considered to have occurred when no response is obtained to the maximum stimulation (64 reading) of the electric pulp tester during the test period. If a patient declared full numbness (i.e., soft tissue anesthesia), the onset will be subsequently tested. The time taken to reach complete anesthesia will be evaluated with a stopwatch. Treatment will be regarded as being successfully completed when it is associated with no pain. After treatment, the subjective efficiency of anesthesia by means of pain while injecting and pain during treatment to be rated by Heft-Parker visual analog scale (VAS) from 0 (no pain) to 10 (worst pain).
The patient's hemodynamic parameters will be measured by using an automated sphygmomanometer as follows: systolic (SBP) and diastolic blood pressure, Oxygen blood saturation (SO2) , and heart rate (HR) rate pressure product ( before each injection (reading 1), before starting the intervention, i.e. 5 min after the injection (reading 2), and at 10-min intervals (readings 3 and 4).
- Conditions
- Hypertension
- Being tested
- 4% Articaine HCL With 1:100,000 Epinephrine, 3% plain mepivacaine HCL
- Keywords
- hemodynamic stability, hypertensive patients, local anesthetic drugs
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4% Articaine HCL With 1:100,000 EpinephrineDrug
Also called Septanest
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.
3% plain mepivacaine HCLDrug
Also called Scandonest
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: 3% plain mepivacaine HCL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog scale
0 represent no pain and 10 represenet severe pain
Measured: 1 hour
systolic (SBP) and diastolic blood pressure
normal 120/80
Measured: 1 hour
heart rate
normal 70
Measured: 1 hour
oxygen saturation
normal 95-98
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start10 Jan 2025
- Primary completion10 Feb 2025
- Study completion10 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Taha Ibrahim, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06927726
- Sponsor's protocol ID
- 4-2025
- Status last verified
- Apr 2025
- First submitted
- 7 Apr 2025
- Last updated
- 18 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Anesthetic Efficacy and Hemodynamic Stability of 4% Articaine (1:100,000 Epinephrine) Versus 3% Mepivacaine Used in Maxillary Teeth Extraction for Hypertensive Patients: A Double-blind Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT06927726
- Acronym / sponsor ID
- 4-2025
- Conditions
- Hypertension
- Keywords
- hemodynamic stability, hypertensive patients, local anesthetic drugs
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 10 Jan 2025 (actual)
- Primary completion
- 10 Feb 2025 (actual)
- Study completion
- 10 Dec 2025 (estimated)
- First posted
- 15 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
The aim of this prospective study is to compare the anesthetic efficacy and hemodynamic parameters of 4% articaine chloridrate with epinephrine (1:100,000) versus 3% mepivacaine chloridrate without epinephrine in maxillary infiltration for teeth extraction of in controlled hypertensive patients.
Material and Methods The main inclusion criteria for this prospective, randomized, double-blinded clinical study will be 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. The exclusion criteria will be 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, and Patients requiring open surgical extractions or with infected teeth were excluded from the study Patients will be selected from Oral and Maxillofacial Surgery Department, Faculty of Dentistry. Tanta University. Equal randomization was achieved with the use of a computer-generated random number list, and signed inform consent will be obtained from every patient included in the study.
Power calculation A study with sixty subjects is reported to have 90% power to detect a difference in success rate of 21% in a continuous outcome measure assuming a significance level of 5% and a correlation of 0.5 between responses from the same subject.
Anaesthetic administration 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 and 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.
Outcome measures of anesthetic success Successful pulp anesthesia is considered to have occurred when no response is obtained to the maximum stimulation (64 reading) of the electric pulp tester during the test period. If a patient declared full numbness (i.e., soft tissue anesthesia), the onset will be subsequently tested. The time taken to reach complete anesthesia will be evaluated with a stopwatch. Treatment will be regarded as being successfully completed when it is associated with no pain. After treatment, the subjective efficiency of anesthesia by means of pain while injecting and pain during treatment to be rated by Heft-Parker visual analog scale (VAS) from 0 (no pain) to 10 (worst pain).
The patient's hemodynamic parameters will be measured by using an automated sphygmomanometer as follows: systolic (SBP) and diastolic blood pressure, Oxygen blood saturation (SO2) , and heart rate (HR) rate pressure product ( before each injection (reading 1), before starting the intervention, i.e. 5 min after the injection (reading 2), and at 10-min intervals (readings 3 and 4).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 4% articaine (1:100,000 epinephrine) | Active comparator | Drug: 4% Articaine HCL With 1:100,000 EpinephrineLocal 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. |
| 3% mepivacaine | Active comparator | Drug: 3% plain mepivacaine HCLLocal 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. |
Who may qualify
- Ages
- Up to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 4% Articaine HCL With 1:100,000 EpinephrineAlso: SeptanestPreoperative 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. | Drug | 4% articaine (1:100,000 epinephrine) |
| 3% plain mepivacaine HCLAlso: ScandonestPreoperative 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. | Drug | 3% mepivacaine |
Primary outcome
Visual analog scale
Time frame: 1 hour
0 represent no pain and 10 represenet severe pain
systolic (SBP) and diastolic blood pressure
Time frame: 1 hour
normal 120/80
heart rate
Time frame: 1 hour
normal 70
oxygen saturation
Time frame: 1 hour
normal 95-98
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 4% Articaine HCL With 1:100,000 Epinephrine and 3% plain mepivacaine HCL in people with Hypertension, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analog scale (time frame: 1 hour). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.