HemodynamicsPhase 4NCT07013071
Hemodynamic Effects of Different Vasoconstrictors in Mandibular Exodontia
A Phase 4 study testing 2% Mepivacaine with 1:100,000 epinephrine and 2% Mepivacaine with 1:55,000 Epinephrine Bitartrate in people with Hemodynamics and Pain, run by King Abdulaziz University at 1 site in Saudi Arabia.
Trial summary
Title of Study: The Effect of Different Vasoconstrictive Agents on Hemodynamics Among Patients Undergoing Simple Mandibular Exodontia: A Triple-Blind Randomized Controlled Trial Location: King Abdulaziz University Dental Hospital (KAUFD), Jeddah, Saudi Arabia What Is This Study About? This study examines two types of… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hemodynamics, Pain, ASA I-II Requiring Simple Dental Extraction of a Mandibular Tooth
- What is being tested?
- 2% Mepivacaine with 1:100,000 epinephrine and 2% Mepivacaine with 1:55,000 Epinephrine Bitartrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 10 Feb 2024to 20 May 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older.
- ASA I or II classification (i.e., healthy or with mild systemic disease).
- Requiring simple mandibular tooth extraction, as defined by painless removal with minimal tissue trauma and smooth postoperative healing.
- Willing and able to provide informed consent.
- Able to comply with study procedures (able to undergo the simple tooth extraction).
Who cannot join
- Pregnant or lactating individuals.
- ASA III or higher classification (i.e., patients with severe systemic disease).
- Patients with uncontrolled systemic disease.
- History of malignancy.
- Presence of unstable psychiatric illness.
- Current use of antiplatelet or anticoagulant medications.
Show all 11Show fewer
- Known allergies to local anesthetics.
- Uncooperative patients or those with intellectual disabilities.
- Cases requiring surgical extractions (e.g., needing tooth sectioning, mucoperiosteal flaps, or bone removal).
- Patients requiring maxillary tooth extraction.
- Presence of fascial space infection or acute oral conditions.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
King Abdulaziz University, Faculty of Dentistry
Jeddah, Mecca Region
About this study
Official title: The Effect of Different Vasoconstrictive Agents on Hemodynamics Among Patients Undergoing Simple Mandibular Exodontia: A Triple-Blind Randomized Controlled Trial
Title of Study:
The Effect of Different Vasoconstrictive Agents on Hemodynamics Among Patients Undergoing Simple Mandibular Exodontia: A Triple-Blind Randomized Controlled Trial
Read more
Location:
King Abdulaziz University Dental Hospital (KAUFD), Jeddah, Saudi Arabia What Is This Study About?
This study examines two types of vasoconstrictive agents used alongside local anesthetic during simple lower tooth extractions:
- Epinephrine (1:100,000)
- Epinephrine Bitartrate (1:55,000)
What are vasoconstrictors? Vasoconstrictors help control bleeding and extend the numbing effect during dental procedures. They are usually added to local anesthetics (numbing agent) during dental procedures. This research aims to answer the following questions:
- Which one of the vasoconstrictive agents has less effect on the heart rate and blood pressure
- Which one offers better pain control?
Who Can participate?
- Adult patient +18 year/old or above (healthy or with well-controlled conditions like hypertension)
- Patients who require non-surgical lower tooth extractions
- Procedures will be done by supervised fifth and sixth-year dental students
Potential Risks and Discomforts
Like any medical procedure, there are some potential risks, including:
From the anesthesia and vasoconstrictors:
- Allergic reaction
- Prolonged numbness
- Changes in blood pressure and heart rate
From the tooth extraction itself:
- Bleeding
- Pain or discomfort
- Swelling or bruising
- Infection
- Dry socket
- Delayed healing
- Damage to nearby teeth or tissues
- Fracture of the tooth or jawbone
- Numbness or altered sensation (temporary or permanent)
- Sinus complications (in upper tooth extractions)
- The need for additional procedures
Potential Benefits
- Free tooth extraction
- Blood pressure monitoring - with referral to a primary care provider if undiagnosed high blood pressure is detected
Costs There are no additional costs to participate in this research. Treatment and extraction are provided free of charge.
Compensation / Treatment for Injury
If a participant is injured as a result of being in this study:
- Necessary treatment and medical care will be provided by the research team.
- No financial compensation is available from King Abdulaziz University Dental Hospital (KAUFD).
Confidentiality Participants' identity and medical information will be kept confidential. Only authorized researchers and relevant oversight bodies may access Participants' medical/dental records for monitoring or auditing purposes, in accordance with laws and regulations. Any published results will not identify the participants.
- Being tested
- 2% Mepivacaine with 1:100,000 epinephrine, 2% Mepivacaine with 1:55,000 Epinephrine Bitartrate
- Keywords
- Mepivacaine 2% with vasoconstrictor, Hemodynamic effects of vasoconstrictors, Epinephrine vs epinephrine bitartrate, Pain control during dental extraction, Blood pressure and heart rate during dental procedures
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2% Mepivacaine with 1:100,000 epinephrineDrug
A standard vasoconstrictor-containing local anesthetic used in dental procedures to minimize bleeding and prolong anesthetic effect.
2% Mepivacaine with 1:55,000 Epinephrine BitartrateDrug
An alternative formulation of vasoconstrictor-containing local anesthetic evaluated for its safety and analgesic effectiveness in dental extractions.
| Study group | Role | What they receive |
|---|---|---|
| Epinephrine Group (1:100,000) | Active comparator | Participants in this group received local anesthesia consisting of 2% mepivacaine hydrochloride with 1:100,000 (0.01 mg/mL) epinephrine prior to simple mandibular tooth extraction. This arm served as the comparator for evaluating hemodynamic changes and pain control. Receives: Drug: 2% Mepivacaine with 1:100,000 epinephrine |
| Epinephrine Bitartrate Group (1:55,000) | Experimental | Participants in this group received local anesthesia consisting of 2% mepivacaine hydrochloride with 1:55,000 (0.018 mg/mL) epinephrine bitartrate prior to simple mandibular tooth extraction. This arm was evaluated for its effects on hemodynamic parameters and pain perception compared to standard epinephrine. Receives: Drug: 2% Mepivacaine with 1:55,000 Epinephrine Bitartrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Systolic and Diastolic Blood Pressure
To compare changes in systolic and diastolic blood pressure between the two groups (epinephrine vs. epinephrine bitartrate) at three time points: before administration of local anesthesia, 3 minutes after administration (intraoperative), and postoperatively following simple mandibular tooth extraction.
Measured: Measured preoperatively, 3 minutes post-anesthesia (intraoperative), and immediately after the procedure (postoperative).
Change in Heart Rate
To evaluate changes in heart rate between the two intervention groups across the same three time points to assess the hemodynamic impact of the vasoconstrictors used.
Measured: Measured preoperatively, 3 minutes post-anesthesia (intraoperative), and immediately after the procedure (postoperative).
Secondary outcomes (1)
Pain Score Using Visual Analogue Scale (VAS)
To compare pain perception during and after the dental procedure between the two groups using a 10-point Visual Analogue Scale (VAS). Patients reported pain at 30-minute intervals throughout the procedure and at the end of treatment. The minimum value on the VAS is 0 and the maximum is 10.
Measured: Assessed every 30 minutes during the procedure and once at the completion of the extraction.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study start10 Feb 2024
- Primary completion20 May 2024
- Study completion20 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for HemodynamicsStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study used a triple-blind, parallel assignment randomized controlled trial design. Participants were randomly assigned to one of two groups: one group received 2% mepivacaine with 1:100,000 epinephrine, and the other received 2% mepivacaine with 1:55,000 epinephrine bitartrate. Both groups underwent simple mandibular tooth extraction, and their hemodynamic responses and pain levels were assessed at standardized intervals. The study maintained blinding across patients, care providers, and outcome assessors to minimize bias.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Abdulaziz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Razan Baabdullah, King Abdulaziz University
- Investigators
- Razan M Baabdullah, BDS, MS, FRCDC, Principal investigator, King Abdulaziz University, Faculty of Dentistry, Department of Oral and Maxillofacial Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07013071
- Sponsor's protocol ID
- 240-11-23
- Status last verified
- Jun 2025
- First submitted
- 2 Jun 2025
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Karm MH, Park FD, Kang M, Kim HJ, Kang JW, Kim S, Kim YD, Kim CH, Seo KS, Kwon KH, Kim CH, Lee JW, Hong SW, Lim MH, Nam SK, Cho JM. Comparison of the efficacy and safety of 2% lidocaine HCl with different epinephrine concentration for local anesthesia in participants undergoing surgical extraction of impacted mandibular third molars: A multicenter, randomized, double-blind, crossover, phase IV trial. Medicine (Baltimore). 2017 May;96(21):e6753. doi: 10.1097/MD.0000000000006753.
PubMed 28538371Gupte SH, Kalra RD, Dcruz TM, Kamble S, Patnaik RS. Comparative Evaluation of Effectiveness of 2% Lignocaine Hydrochloride with Clonidine Hydrochloride versus 2% Lignocaine Hydrochloride with Adrenaline Bitartrate as Local Anesthetic for Adult Patients Undergoing Surgical Extraction of Impacted Mandibular Third Molars: A Randomized Controlled Clinical Study. Contemp Clin Dent. 2021 Jul-Sep;12(3):308-312. doi: 10.4103/ccd.ccd_665_20. Epub 2021 Sep 21.
PubMed 34759690Abu-Mostafa N, Al-Showaikhat F, Al-Shubbar F, Al-Zawad K, Al-Zawad F. Hemodynamic changes following injection of local anesthetics with different concentrations of epinephrine during simple tooth extraction: A prospective randomized clinical trial. J Clin Exp Dent. 2015 Oct 1;7(4):e471-6. doi: 10.4317/jced.52321. eCollection 2015 Oct.
PubMed 26535092Conrado VC, de Andrade J, de Angelis GA, de Andrade AC, Timerman L, Andrade MM, Moreira DR, Sousa AG, Sousa JE, Piegas LS. Cardiovascular effects of local anesthesia with vasoconstrictor during dental extraction in coronary patients. Arq Bras Cardiol. 2007 May;88(5):507-13. doi: 10.1590/s0066-782x2007000500002. English, Portuguese.
PubMed 17589623Silvestre FJ, Martinez-Herrera M, Garcia-Lopez B, Silvestre-Rangil J. Influence of anxiety and anesthetic vasoconstrictors upon hemodynamic parameters during dental procedures in controlled hypertensive and non-hypertensive patients. J Clin Exp Dent. 2021 Feb 1;13(2):e156-e164. doi: 10.4317/jced.57232. eCollection 2021 Feb.
PubMed 33575000Seminario-Amez M, Gonzalez-Navarro B, Ayuso-Montero R, Jane-Salas E, Lopez-Lopez J. USE OF LOCAL ANESTHETICS WITH A VASOCONSTRICTOR AGENT DURING DENTAL TREATMENT IN HYPERTENSIVE AND CORONARY DISEASE PATIENTS. A SYSTEMATIC REVIEW. J Evid Based Dent Pract. 2021 Jun;21(2):101569. doi: 10.1016/j.jebdp.2021.101569. Epub 2021 Apr 10.
PubMed 34391560Ezmek B, Arslan A, Delilbasi C, Sencift K. Comparison of hemodynamic effects of lidocaine, prilocaine and mepivacaine solutions without vasoconstrictor in hypertensive patients. J Appl Oral Sci. 2010 Jul-Aug;18(4):354-9. doi: 10.1590/s1678-77572010000400006.
PubMed 20835569Tsuchihashi T, Takata Y, Kurokawa H, Miura K, Maruoka Y, Kajiyama M, Fujishima M. Blood pressure response during dental surgery. Hypertens Res. 1996 Sep;19(3):189-94. doi: 10.1291/hypres.19.189.
PubMed 8891747Silvestre FJ, Salvador-Martinez I, Bautista D, Silvestre-Rangil J. Clinical study of hemodynamic changes during extraction in controlled hypertensive patients. Med Oral Patol Oral Cir Bucal. 2011 May 1;16(3):e354-8. doi: 10.4317/medoral.16.e354.
PubMed 21196862Abhijith George, Mandeep Sharma, Prasanna Kumar, Sneha Kulkarni, Vinay Patil y Jacob John Plackal. Hemodynamic changes during exodontia in hypertensive and normotensive patients following injection of local anesthetics with and without epinephrine: a prospective comparative study. Rev Esp Cir Oral Maxilofac. 2022;44(1):9-15.
Ogunlewe MO, James O, Ajuluchukwu JN, Ladeinde AL, Adeyemo WL, Gbotolorun OM. Evaluation of haemodynamic changes in hypertensive patients during tooth extraction under local anaesthesia. West Indian Med J. 2011 Jan;60(1):91-5.
PubMed 21809720Matsumura K, Miura K, Takata Y, Kurokawa H, Kajiyama M, Abe I, Fujishima M. Changes in blood pressure and heart rate variability during dental surgery. Am J Hypertens. 1998 Nov;11(11 Pt 1):1376-80. doi: 10.1016/s0895-7061(98)00157-5.
PubMed 9832183
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Vasoconstrictive Agents on Hemodynamics Among Patients Undergoing Simple Mandibular Exodontia: A Triple-Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07013071
- Acronym / sponsor ID
- 240-11-23
- Keywords
- Mepivacaine 2% with vasoconstrictor, Hemodynamic effects of vasoconstrictors, Epinephrine vs epinephrine bitartrate, Pain control during dental extraction, Blood pressure and heart rate during dental procedures
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- King Abdulaziz UniversityUniversity, hospital or other
- Study start
- 10 Feb 2024 (actual)
- Primary completion
- 20 May 2024 (actual)
- Study completion
- 20 May 2024 (actual)
- First posted
- 10 Jun 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.
Title of Study:
The Effect of Different Vasoconstrictive Agents on Hemodynamics Among Patients Undergoing Simple Mandibular Exodontia: A Triple-Blind Randomized Controlled Trial
Location:
King Abdulaziz University Dental Hospital (KAUFD), Jeddah, Saudi Arabia What Is This Study About?
This study examines two types of vasoconstrictive agents used alongside local anesthetic during simple lower tooth extractions:
- Epinephrine (1:100,000)
- Epinephrine Bitartrate (1:55,000)
What are vasoconstrictors? Vasoconstrictors help control bleeding and extend the numbing effect during dental procedures. They are usually added to local anesthetics (numbing agent) during dental procedures. This research aims to answer the following questions:
- Which one of the vasoconstrictive agents has less effect on the heart rate and blood pressure
- Which one offers better pain control?
Who Can participate?
- Adult patient +18 year/old or above (healthy or with well-controlled conditions like hypertension)
- Patients who require non-surgical lower tooth extractions
- Procedures will be done by supervised fifth and sixth-year dental students
Potential Risks and Discomforts
Like any medical procedure, there are some potential risks, including:
From the anesthesia and vasoconstrictors:
- Allergic reaction
- Prolonged numbness
- Changes in blood pressure and heart rate
From the tooth extraction itself:
- Bleeding
- Pain or discomfort
- Swelling or bruising
- Infection
- Dry socket
- Delayed healing
- Damage to nearby teeth or tissues
- Fracture of the tooth or jawbone
- Numbness or altered sensation (temporary or permanent)
- Sinus complications (in upper tooth extractions)
- The need for additional procedures
Potential Benefits
- Free tooth extraction
- Blood pressure monitoring - with referral to a primary care provider if undiagnosed high blood pressure is detected
Costs There are no additional costs to participate in this research. Treatment and extraction are provided free of charge.
Compensation / Treatment for Injury
If a participant is injured as a result of being in this study:
- Necessary treatment and medical care will be provided by the research team.
- No financial compensation is available from King Abdulaziz University Dental Hospital (KAUFD).
Confidentiality Participants' identity and medical information will be kept confidential. Only authorized researchers and relevant oversight bodies may access Participants' medical/dental records for monitoring or auditing purposes, in accordance with laws and regulations. Any published results will not identify the participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- This study used a triple-blind, parallel assignment randomized controlled trial design. Participants were randomly assigned to one of two groups: one group received 2% mepivacaine with 1:100,000 epinephrine, and the other received 2% mepivacaine with 1:55,000 epinephrine bitartrate. Both groups underwent simple mandibular tooth extraction, and their hemodynamic responses and pain levels were assessed at standardized intervals. The study maintained blinding across patients, care providers, and outcome assessors to minimize bias.
| Arm | Type | Receives |
|---|---|---|
| Epinephrine Group (1:100,000) | Active comparator | Drug: 2% Mepivacaine with 1:100,000 epinephrineParticipants in this group received local anesthesia consisting of 2% mepivacaine hydrochloride with 1:100,000 (0.01 mg/mL) epinephrine prior to simple mandibular tooth extraction. This arm served as the comparator for evaluating hemodynamic changes and pain control. |
| Epinephrine Bitartrate Group (1:55,000) | Experimental | Drug: 2% Mepivacaine with 1:55,000 Epinephrine BitartrateParticipants in this group received local anesthesia consisting of 2% mepivacaine hydrochloride with 1:55,000 (0.018 mg/mL) epinephrine bitartrate prior to simple mandibular tooth extraction. This arm was evaluated for its effects on hemodynamic parameters and pain perception compared to standard epinephrine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 18 years or older.
- ASA I or II classification (i.e., healthy or with mild systemic disease).
- Requiring simple mandibular tooth extraction, as defined by painless removal with minimal tissue trauma and smooth postoperative healing.
- Willing and able to provide informed consent.
- Able to comply with study procedures (able to undergo the simple tooth extraction).
Key exclusion criteria (11 listed)
- Pregnant or lactating individuals.
- ASA III or higher classification (i.e., patients with severe systemic disease).
- Patients with uncontrolled systemic disease.
- History of malignancy.
- Presence of unstable psychiatric illness.
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 |
|---|---|---|
| 2% Mepivacaine with 1:100,000 epinephrineA standard vasoconstrictor-containing local anesthetic used in dental procedures to minimize bleeding and prolong anesthetic effect. | Drug | Epinephrine Group (1:100,000) |
| 2% Mepivacaine with 1:55,000 Epinephrine BitartrateAn alternative formulation of vasoconstrictor-containing local anesthetic evaluated for its safety and analgesic effectiveness in dental extractions. | Drug | Epinephrine Bitartrate Group (1:55,000) |
Primary outcome
Change in Systolic and Diastolic Blood Pressure
Time frame: Measured preoperatively, 3 minutes post-anesthesia (intraoperative), and immediately after the procedure (postoperative).
To compare changes in systolic and diastolic blood pressure between the two groups (epinephrine vs. epinephrine bitartrate) at three time points: before administration of local anesthesia, 3 minutes after administration (intraoperative), and postoperatively following simple mandibular tooth extraction.
Change in Heart Rate
Time frame: Measured preoperatively, 3 minutes post-anesthesia (intraoperative), and immediately after the procedure (postoperative).
To evaluate changes in heart rate between the two intervention groups across the same three time points to assess the hemodynamic impact of the vasoconstrictors used.
1 secondary outcome
Pain Score Using Visual Analogue Scale (VAS)
Time frame: Assessed every 30 minutes during the procedure and once at the completion of the extraction.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
- Results publication: PubMed 28538371Karm MH, Park FD, Kang M, Kim HJ, Kang JW, Kim S, Kim YD, Kim CH, Seo KS, Kwon KH, Kim CH, Lee JW, Hong SW, Lim MH, Nam SK, Cho JM. Comparison of the efficacy and safety of 2% lidocaine HCl with different epinephrine concentration for local anesthesia in participants undergoing surgical extraction of impacted mandibular third molars: A multicenter, randomized, double-blind, crossover, phase IV trial. Medicine (Baltimore). 2017 May;96(21):e6753. doi: 10.1097/MD.0000000000006753.
- Results publication: PubMed 34759690Gupte SH, Kalra RD, Dcruz TM, Kamble S, Patnaik RS. Comparative Evaluation of Effectiveness of 2% Lignocaine Hydrochloride with Clonidine Hydrochloride versus 2% Lignocaine Hydrochloride with Adrenaline Bitartrate as Local Anesthetic for Adult Patients Undergoing Surgical Extraction of Impacted Mandibular Third Molars: A Randomized Controlled Clinical Study. Contemp Clin Dent. 2021 Jul-Sep;12(3):308-312. doi: 10.4103/ccd.ccd_665_20. Epub 2021 Sep 21.
- Results publication: PubMed 26535092Abu-Mostafa N, Al-Showaikhat F, Al-Shubbar F, Al-Zawad K, Al-Zawad F. Hemodynamic changes following injection of local anesthetics with different concentrations of epinephrine during simple tooth extraction: A prospective randomized clinical trial. J Clin Exp Dent. 2015 Oct 1;7(4):e471-6. doi: 10.4317/jced.52321. eCollection 2015 Oct.
- Results publication: PubMed 17589623Conrado VC, de Andrade J, de Angelis GA, de Andrade AC, Timerman L, Andrade MM, Moreira DR, Sousa AG, Sousa JE, Piegas LS. Cardiovascular effects of local anesthesia with vasoconstrictor during dental extraction in coronary patients. Arq Bras Cardiol. 2007 May;88(5):507-13. doi: 10.1590/s0066-782x2007000500002. English, Portuguese.
- Results publication: PubMed 33575000Silvestre FJ, Martinez-Herrera M, Garcia-Lopez B, Silvestre-Rangil J. Influence of anxiety and anesthetic vasoconstrictors upon hemodynamic parameters during dental procedures in controlled hypertensive and non-hypertensive patients. J Clin Exp Dent. 2021 Feb 1;13(2):e156-e164. doi: 10.4317/jced.57232. eCollection 2021 Feb.
- Results publication: PubMed 34391560Seminario-Amez M, Gonzalez-Navarro B, Ayuso-Montero R, Jane-Salas E, Lopez-Lopez J. USE OF LOCAL ANESTHETICS WITH A VASOCONSTRICTOR AGENT DURING DENTAL TREATMENT IN HYPERTENSIVE AND CORONARY DISEASE PATIENTS. A SYSTEMATIC REVIEW. J Evid Based Dent Pract. 2021 Jun;21(2):101569. doi: 10.1016/j.jebdp.2021.101569. Epub 2021 Apr 10.
- Results publication: PubMed 20835569Ezmek B, Arslan A, Delilbasi C, Sencift K. Comparison of hemodynamic effects of lidocaine, prilocaine and mepivacaine solutions without vasoconstrictor in hypertensive patients. J Appl Oral Sci. 2010 Jul-Aug;18(4):354-9. doi: 10.1590/s1678-77572010000400006.
- Results publication: PubMed 8891747Tsuchihashi T, Takata Y, Kurokawa H, Miura K, Maruoka Y, Kajiyama M, Fujishima M. Blood pressure response during dental surgery. Hypertens Res. 1996 Sep;19(3):189-94. doi: 10.1291/hypres.19.189.
- Results publication: PubMed 21196862Silvestre FJ, Salvador-Martinez I, Bautista D, Silvestre-Rangil J. Clinical study of hemodynamic changes during extraction in controlled hypertensive patients. Med Oral Patol Oral Cir Bucal. 2011 May 1;16(3):e354-8. doi: 10.4317/medoral.16.e354.
- Results publicationAbhijith George, Mandeep Sharma, Prasanna Kumar, Sneha Kulkarni, Vinay Patil y Jacob John Plackal. Hemodynamic changes during exodontia in hypertensive and normotensive patients following injection of local anesthetics with and without epinephrine: a prospective comparative study. Rev Esp Cir Oral Maxilofac. 2022;44(1):9-15.
- Results publication: PubMed 21809720Ogunlewe MO, James O, Ajuluchukwu JN, Ladeinde AL, Adeyemo WL, Gbotolorun OM. Evaluation of haemodynamic changes in hypertensive patients during tooth extraction under local anaesthesia. West Indian Med J. 2011 Jan;60(1):91-5.
- Results publication: PubMed 9832183Matsumura K, Miura K, Takata Y, Kurokawa H, Kajiyama M, Abe I, Fujishima M. Changes in blood pressure and heart rate variability during dental surgery. Am J Hypertens. 1998 Nov;11(11 Pt 1):1376-80. doi: 10.1016/s0895-7061(98)00157-5.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Razan M Baabdullah, BDS, MS, FRCDC principal investigator
King Abdulaziz University, Faculty of Dentistry, Department of Oral and Maxillofacial Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 2% Mepivacaine with 1:100,000 epinephrine and 2% Mepivacaine with 1:55,000 Epinephrine Bitartrate in people with Hemodynamics and Pain, run by King Abdulaziz University at 1 site in Saudi Arabia.
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 5 inclusion and 11 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: finished, as of the sponsor's last update on 12 Jun 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 Saudi Arabia. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Systolic and Diastolic Blood Pressure (time frame: Measured preoperatively, 3 minutes post-anesthesia (intraoperative), and immediately after the procedure (postoperative).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07013071, which also lists 12 linked publications.
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 12 Jun 2025.