Clinical trial NCT07013071: Hemodynamic Effects of Different Vasoconstrictors in Mandibular Exodontia
Official title: The Effect of Different Vasoconstrictive Agents on Hemodynamics Among Patients Undergoing Simple Mandibular Exodontia: A Triple-Blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hemodynamics
Pain
ASA I-II Requiring Simple Dental Extraction of a Mandibular Tooth
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
Lead sponsor: King Abdulaziz University
Sponsor class: OTHER
First posted: 2025-06-10
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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 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:

1. Which one of the vasoconstrictive agents has less effect on the heart rate and blood pressure
2. 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.


Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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.
* 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.

Primary outcomes:
measure: Change in Systolic and Diastolic Blood Pressure
timeFrame: Measured preoperatively, 3 minutes post-anesthesia (intraoperative), and immediately after the procedure (postoperative).
measure: Change in Heart Rate
timeFrame: Measured preoperatively, 3 minutes post-anesthesia (intraoperative), and immediately after the procedure (postoperative).
Secondary outcomes:
measure: Pain Score Using Visual Analogue Scale (VAS)
timeFrame: Assessed every 30 minutes during the procedure and once at the completion of the extraction.
Other outcomes:
Locations:
city: Jeddah
country: Saudi Arabia
facility: King Abdulaziz University, Faculty of Dentistry
state: Makkah
Study officials:
affiliation: King Abdulaziz University, Faculty of Dentistry, Department of Oral and Maxillofacial Surgery
name: Razan M Baabdullah, BDS, MS, FRCDC
role: PRINCIPAL_INVESTIGATOR
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