Study on Pain Relief for Dental Procedures in Patients with MC1R Mutation Using Lidocaine-Prilocaine Combination and Lidocaine Alone

2 1 1 1

What is this study about?

This clinical trial is focused on dental procedures that require local anesthesia. The study is investigating the effectiveness of two different anesthetic solutions. One solution is a combination of lidocaine and prilocaine, while the other contains only lidocaine. These medications are used to numb the area in the mouth where dental work is being performed, helping to reduce pain during the procedure.

The purpose of the study is to compare how well these two anesthetic solutions work in people who have a specific genetic trait known as the MC1R mutation. This mutation is often associated with red hair. Participants in the study will receive either the lidocaine-prilocaine combination or the lidocaine alone, and the effectiveness of the anesthesia will be assessed during their dental treatment.

Throughout the study, participants will undergo dental procedures where the anesthetic solutions will be used. The study will measure how well the anesthesia works by checking if the participants feel any sensation in the treated area. The study will also gather feedback from participants about their experience with the anesthesia. This research aims to provide valuable information on the best anesthetic options for dental procedures in individuals with the MC1R mutation.

1 joining the study

Upon joining the study, participants will be required to provide written informed consent. This confirms understanding and agreement to participate in the study.

2 initial assessment

Participants will undergo an initial assessment to confirm eligibility. This includes verifying age between 18 and 65, and confirming the presence of red hair or a family history of red hair.

3 randomization

Participants will be randomly assigned to receive either a combination of lidocaine-prilocaine or lidocaine alone as local anesthesia for dental procedures. This process is double-blind, meaning neither the participant nor the study team will know which treatment is being administered.

4 administration of anesthesia

The assigned anesthesia will be administered as a solution for injection before the dental procedure. The specific product used will be either Citanest® Dental Octapressin 30 mg/ml + 0.03 IE/ml or Xylocain® Dental adrenalin 20 mg/ml + 12.5 microg/ml.

5 evaluation of anesthesia effectiveness

The effectiveness of the anesthesia will be evaluated using an electric pulp tester. Successful anesthesia is indicated by two consecutive 64/64 readings without any participant response within 10 minutes.

Additional evaluations include a cold sensation test using ice and the participant’s assessment of soft tissue anesthesia during a standard pocket procedure. Participants will also rate their experience of anesthesia on a scale from 1 to 5.

6 completion of the study

The study is expected to conclude by December 31, 2024. Participants will be informed of the study’s findings and any relevant information regarding their participation.

Who Can Join the Study?

Participants must be between the ages of 18 and 65.
Participants must provide written informed consent to join the study. This means they agree to participate after being fully informed about the study’s details.
Participants must have red hair or have at least one parent, grandparent, or genetic sibling with red hair.

Who Cannot Join the Study?

Patients who are not having local anesthesia for dental procedures cannot participate. Local anesthesia is a type of medicine used to numb a small area of the body, so you don’t feel pain during a procedure.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name	City	Country	Status
Sve Txtvvuutzkqzys Au	Ski	Norway

Trial status

Country	Status	Recruitment Start
Norway	Not recruiting	14.10.2024

Trial locations

Investigated drugs:

Lidocaine-Prilocaine Combination is a mixture of two local anesthetics used to numb a specific area of the body. In this clinical trial, it is being tested to see how well it can reduce pain during dental procedures for people with a specific genetic mutation. The combination is applied to the gums or other areas in the mouth to help prevent pain during dental work.

Lidocaine is a local anesthetic that is commonly used to numb tissues in a specific area. In this trial, it is used alone to see how effective it is at reducing pain during dental procedures. It works by blocking nerve signals in your body, which helps to prevent pain during dental treatments.

Local Anesthesia – Local anesthesia is a temporary loss of sensation in a specific area of the body, typically used to prevent pain during medical or dental procedures. It works by blocking nerve signals in the targeted area, preventing them from reaching the brain. The onset of anesthesia is usually rapid, and the effects can last for a short period, depending on the type and amount of anesthetic used. During the procedure, the patient remains conscious and aware but does not feel pain in the anesthetized area. As the anesthetic wears off, sensation gradually returns to the area. Local anesthesia is commonly used in minor surgical and dental procedures to ensure patient comfort.

Trial ID:

2024-515965-32-00

Protocol code:

PVX 2024-01

Trial Phase:

Therapeutic exploratory (Phase II)

Other Trials to Consider

#1 Clinical Trials Search in Europe

Study on Pain Relief for Dental Procedures in Patients with MC1R Mutation Using Lidocaine-Prilocaine Combination and Lidocaine Alone

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?