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IRCT20211127053190N1 IRCT 2021-12-01 Shahid Beheshti University of Medical Sciences Comparison of cardiovascular effects of ropevacaine and lidocaine with epinephrine in implant surgery Comparative evaluation of cardiovascular effects of 0.5% Ropivacaine front 2% Lidocaine with 1:80000 epinephrine in implant surgery, A double-blind crossover clinical trial 2021-12-13 anticipated 18 Complete https://irct.ir/trial/60268 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: After the patient's eligibility is determined, the procedure will be explained to the patient and moral satisfaction will be obtained. A simple randomization method is used. The surgical site as well as the type of local anesthesia in the first session are both determined by dropping the coin by the assistant. Both sides (left and right) in a jaw will recieve 1 implant with the same surgical procedure without bone augmentation. Two weeks later, surgery will be performed on the other side with the other anesthetic drug, Blinding description: After determining the type of anesthesia for the first session by dropping the coin, the assistant draws up the drug into the insulin syringes, and delivers it to the surgeon. The assistant will be the only aware person of the type of drug and has no role in further procedures. Both anesthetic drugs are colorlessness and clear, so the insulin syringes will not be covered. After completing the injection and starting the surgery, the parameters are recorded by the surgeon. Both the patient and the surgeon are unaware of the type of local anesthesia. 2 Hemodynamic effects. Intervention 1: Intervention group: 3.6 millilitre of the anaesthetic solution is drawn with insulin syringes from 10 millilitre vial of 0.5% ropivacaine made by Molteni Pharmaceutical Company. The injection technique in lower jaw is buccal and lingual infiltration (1 millilitre and 1 millilitre), and in upper jaw is buccal infiltration and greater palatine block (1.5 millilitre and 0.5 millilitre). Then performing the surgical steps of placing a dental implant begins. Intervention 2: Control group: 3.6 millilitre of the anaesthetic solution is drawn with insulin syringes from 1.8 millilitre carpules of 2% lidocaine with epinephrine 1/80000 made by Darou Pakhsh Pharmaceutical Company. The injection technique in lower jaw is buccal and lingual infiltration (1 millilitre and 1 millilitre), and in upper jaw is buccal infiltration and greater palatine block (1.5 millilitre and 0.5 millilitre). Then performing the surgical steps of placing a dental implant begins. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Negar Daneshvar
Shahid beheshti dental school, Daneshjoo Blvd, Evin, Tehran
Tehran Iran (Islamic Republic of) 1983969411 +98 21 2240 3010 dr.negardaneshvar@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Negar Daneshvar
Shahid beheshti dental school, Daneshjoo Blvd, Evin, Tehran
Tehran Iran (Islamic Republic of) 1983969411 +98 21 2240 3010 dr.negardaneshvar@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Patients who need to place 1 implant bilaterally in the posterior areas (premolar or molar) in one jaw Systemically healthy individuals (ASA I) 20 years 70 years Both Patients with a history of allergy to local anesthetic agents, amides and sulfides Patients with acute or chronic infection near the surgical site Smokers Alcohol consumption Consumers of antipsychotic drugs, antidepressants and oral contraceptives People who have taken painkillers in the 48 hours before surgery People with a history of chronic facial pain Pregnant and lactating women Patients who need immediate implant placement (class1) Patients who need open / closed sinus lift surgery at the surgical site Patients who need bone augmentation (GBR) at the surgical site Patients who refuse to take part in the research Prevention Prevention Intervention group: 3.6 millilitre of the anaesthetic solution is drawn with insulin syringes from 10 millilitre vial of 0.5% ropivacaine made by Molteni Pharmaceutical Company. The injection technique in lower jaw is buccal and lingual infiltration (1 millilitre and 1 millilitre), and in upper jaw is buccal infiltration and greater palatine block (1.5 millilitre and 0.5 millilitre). Then performing the surgical steps of placing a dental implant begins. Control group: 3.6 millilitre of the anaesthetic solution is drawn with insulin syringes from 1.8 millilitre carpules of 2% lidocaine with epinephrine 1/80000 made by Darou Pakhsh Pharmaceutical Company. The injection technique in lower jaw is buccal and lingual infiltration (1 millilitre and 1 millilitre), and in upper jaw is buccal infiltration and greater palatine block (1.5 millilitre and 0.5 millilitre). Then performing the surgical steps of placing a dental implant begins. Heart rate. Timepoint: Before the injection, immediately after the injection, 10 minutes after the injection, 20 minutes after the injection, 30 minutes after the injection, 1 hour after the injection. Method of measurement: Pulse Oximeter. Systolic blood pressure. Timepoint: Before the injection, immediately after the injection, 10 minutes after the injection, 20 minutes after the injection, 30 minutes after the injection, 1 hour after the injection. Method of measurement: Wrist Blood Pressure Monitor. Diastolic blood pressure. Timepoint: Before the injection, immediately after the injection, 10 minutes after the injection, 20 minutes after the injection, 30 minutes after the injection, 1 hour after the injection. Method of measurement: Wrist Blood Pressure Monitor. Saturation of Peripheral Oxygen (SPo2). Timepoint: Before the injection, immediately after the injection, 10 minutes after the injection, 20 minutes after the injection, 30 minutes after the injection, 1 hour after the injection. Method of measurement: Pulse Oximeter. Onset of anesthesia. Timepoint: From the time when the needle is pulled out of the tissue. Method of measurement: Stopwatch. Duration of anesthesia. Timepoint: From the time when the needle is pulled out of the tissue until the anesthetic effect wears off. Method of measurement: Stopwatch. The amount of pain felt during the injection. Timepoint: During the injection. Method of measurement: Visual Analogue Scale. The amount of pain felt during the surgery. Timepoint: During the surgery. Method of measurement: Visual Analogue Scale. Duration of analgesia after the surgery. Timepoint: From the time when the needle is pulled out of the tissue until the time of the onset of pain after the surgery. Method of measurement: Stopwatch. Numbers of painkillers taken after the surgery. Timepoint: After the end of the surgery to 1 week. Method of measurement: questionnaire. Shahid Beheshti University of Medical Sciences Approved 2020-08-25 Ethics committee of Shahid Beheshti University of Medical Sciences Shahid Beheshti School of Dentistry, Daneshjou Blvd, Evin, Tehran Tehran Tehran Iran (Islamic Republic of)