Hemodynamic Effects of Different Vasoconstrictors in Mandibular Exodontia

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.

Conditions

• Hemodynamics
• Pain
• ASA I-II Requiring Simple Dental Extraction of a Mandibular Tooth

Interventions

DRUG

2% Mepivacaine with 1:100,000 epinephrine

A standard vasoconstrictor-containing local anesthetic used in dental procedures to minimize bleeding and prolong anesthetic effect.

DRUG

2% Mepivacaine with 1:55,000 Epinephrine Bitartrate

An alternative formulation of vasoconstrictor-containing local anesthetic evaluated for its safety and analgesic effectiveness in dental extractions.

Sponsors & Collaborators

• King Abdulaziz University

  lead OTHER

Principal Investigators

• Razan M Baabdullah, BDS, MS, FRCDC · King Abdulaziz University, Faculty of Dentistry, Department of Oral and Maxillofacial Surgery

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-02-10

Primary Completion

2024-05-20

Completion

2024-05-20

Countries

• Saudi Arabia

Study Locations