Hemodynamic Effects of Different Vasoconstrictors in Mandibular Exodontia

King Abdulaziz University

Status and phase: Completed; Phase 4

Conditions: ASA I-II Requiring Simple Dental Extraction of a Mandibular Tooth; Pain; Hemodynamics

Treatments: Drug: 2% Mepivacaine with 1:100,000 epinephrine; Drug: 2% Mepivacaine with 1:55,000 Epinephrine Bitartrate

Study type: Interventional

Funder types: Other

Identifiers

NCT07013071

240-11-23

Details and patient eligibility

About

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.

Enrollment: 52 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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52 participants in 2 patient groups

Epinephrine Group (1:100,000)

Active Comparator group

Description:

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.

Treatment:

Drug: 2% Mepivacaine with 1:100,000 epinephrine

Epinephrine Bitartrate Group (1:55,000)

Experimental group

Description:

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.

Treatment:

Drug: 2% Mepivacaine with 1:55,000 Epinephrine Bitartrate