Preparation and comparison of buccal patches containing lidocaine and dexmedetomidine with articaine and dexmedetomidine in reduction of injection pain and increment of patients compliance in dental procedures

Reducing injection pain and increasing patient cooperation in dental practices.

A controlled, parallel-group, double-blind, randomized, phase 2 clinical trial on 180 patients. Random number table is used for randomization.

This clinical study is randomized and double-blinded in Al-Zahra Hospital, Isfahan.180 adult patients with an age range of 20-35 years are selected. People are randomly selected and receive 1x1 cm patches containing the drug, and after 10 minutes, a supra periosteal lidocaine injection is performed by a dentist in the patient's mouth. Two control groups receive the drug-free patch and injectable lidocaine.

Participants have participation for the study and have referred to receive dental services that require local anesthesia. Patients must be free of any systemic disease (cardiovascular disease, diabetes, etc.), physical and mental disease, allergy to lidocaine and articaine, dental phobia, inflammation, abscess, and history of surgery at the injection site. Also, they do not have a history of taking any painkillers and corticosteroids in the last week. Patients who have a special emergency during the injection process and can not complete the case are excluded from the study. Also, patients who have pain during visit are not included in the study.

Qualified people are divided into 6 groups: 1) Patche containing 350 mg of lidocaine, 2) Patche containing 350 mg of articaine, 3) Patche containing 350 mg of lidocaine + 1 microgram per kilogram of dexmedetomidine 4) Patche containing 350 mg 1 gram of articaine + 1 microgram per kilogram of dexmedetomidine , 5) Control is divided into two subgroups, one group of people will receive drug-free patch and the other group will only receive injectable lidocaine.

The patient's pain level (VAS Score criterion).

We use the random number table method. Each patient is assigned a number, and based on the random number table, an envelope is considered for each patient. On the envelope, the name, surname, number associated with that patient and the patch are placed inside. This envelope is opened by the project manager (neither the patient nor the dentist can see the contents of the envelope). Then the dentist apply the patch to the patient and after its effect, dentist perform the injection.

In the randomization description section, we explained about the envelope related to the patient and its contents. This envelope is opened by the project manager (neither the patient nor the dentist can see the contents of the envelope).