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IRCT20230719058849N1 IRCT 2023-07-31 Mazandaran University of Medical Sciences Investigating the effect of needle entry angle on the amount of pain during premaxilla labial infiltration injection in patients referred to the special oral and maxillofacial surgery Investigating the effect of needle entry angle on the amount of pain during premaxilla labial infiltration injection in patients referred to the special oral and maxillofacial surgery 2023-08-23 anticipated 36 Complete https://irct.ir/trial/71657 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: All eligible people are randomly assigned to four groups (A-D) in the first stage. In the following, using Excel software, the samples are placed in 9 blocks of 4. (The total sample size is 36). Blocks of 4 are formed as ADCB, ADBC, ACDB, ACBD, ABDC, ABCD, etc.) For example: four people refer to the center where the groups are supposed to be assigned. In the Excel software, between the number 1 and 24, supposedly the number 2 is chosen by chance; Therefore, these four people are assigned to the ABDC block in the order of reference. In fact, the first person enters group A, the second person enters group B, the third person enters group D, and the fourth person enters group C, Blinding description: In this study, due to the nature of the intervention, it is not possible to blind the patient and the researcher, and only blinding will be done for data analysis. N/A This study is not done on specific patients. Only the amount of pain after different injection techniques will be investigated and compared.. Intervention 1: Intervention group: Group A: injection of labial infiltration in the anterior of the maxilla parallel to the longitudinal axis of the tooth with a normal syringe - in this group anesthesia, in the form of infiltration, in the apex of the maxillary left central tooth by conventional method or parallel to the longitudinal axis of the tooth using a normal syringe and a 12 mm short needle head of 30 gauge and lidocaine anesthetic agent with epinephrine 1:100000 in the amount of 1.2 ml (approximately equivalent to two thirds of the cartridge) are applied to the patient in the semi-supine position. Intervention 2: Intervention group: Group B: labial infiltration injection in the anterior of the maxilla with a new method and angle (α) with a normal syringe - in this group anesthesia, in the form of infiltration, in the apex area of the left central tooth of the maxilla with a new method so that in this method first three anatomical planes (sagittal-occlusal-frontal) are considered. Then, the needle is inserted at an angle α (65 degrees to the sagittal plane or the longitudinal axis of the tooth/35 degrees to the occlusal plane/80 degrees to the frontal plane) in the depth of the mucobuccal fold of the maxillary left central tooth. The injection is applied to the patient in the semi-supine position using a regular syringe and a short needle head of 30 gauge and an anesthetic agent of lidocaine with epinephrine 1:100000 in the amount of two thirds of the cartridge. Intervention 3: Intervention group: Group C: labial infiltration injection in the anterior of the maxilla using CCLAD parallel to the longitudinal axis of the tooth - in this group anesthesia, in the form of infiltration, in the apex of the maxillary left central tooth by conventional method or parallel to the longitudinal axis of the tooth using the computerized injection technique and 12 mm short needle head 30 gauge and lidocaine anesthetic agent with epinephrine 1:100000 in the amount of 1.2 ml (approximately equivalent to two thirds of the cartridge) is applied to the patient in the semi-supine position. Intervention 4: Intervention group: Group D: Labial infiltration injection in the anterior of the maxilla using CCLAD with a new method and angle (α) - in this group anesthesia, in the form of infiltration, in the apex area of ​​the left central tooth of the maxilla in a new way so that in this method First, three anatomical planes (sagittal-occlusal-frontal) are considered. Then, the needle is inserted at an angle α (65 degrees to the sagittal plane or the longitudinal axis of the tooth/35 degrees to the occlusal plane/80 degrees to the frontal plane) in the depth of the mucobuccal fold of the maxillary left central tooth. The injection is applied to the patient using a computerized injection technique and a 30-gauge short needle head and an anesthetic agent of lidocaine with epinephrine 1:100,000 in the amount of two-thirds of the cartridge in the semi-supine position. Yes - There is a plan to make this available What will be shared: After the completion of the study and the publication of the resulting article,all the mentioned documents will be available upon request from the researcher author. When: The start of the access period, 6 months after the publication of the article resulting from the project. To whom: All people Conditions: All documents will be available upon request from the responsible researcher. Where to obtain: Responsible researcher: Dr. Amirhossein Moaddabi, address: Khazar Blvd., Mazandaran, Sari, Baghban Dental Clinic, contact number: 09127103916 and email: a.moaddabi2@gmail.com How to obtain: It can be received from the responsible researcher through a personal visit, phone call or e-mail. Comments:
public Amirhossein Moaddabi
Baghban Dental Clinic, Khazar Boulevard, Sari
Sari Iran (Islamic Republic of) 4816895475 +98 11 3324 4894 a.moaddabi2@gmail.com Mazandaran University of Medical Sciences scientific Amirhossein Moaddabi
Baghban Dental Clinic, Khazar Boulevard, Sari
Sari Iran (Islamic Republic of) 4819895475 +98 11 3324 4894 a.moaddabi2@gmail.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Healthy individuals (ASA 1 & ASA 2 based on American society of anesthesiologist classification) who are healthy in terms of written records (based on the individual's records in their medical record) and oral question (interview). The GHQ-28 general health questionnaire (available in the appendix) is used to equalize the participants psychologically. The validity and reliability of the questionnaire in Persian version is confirmed. Participants should not take any medication that alters their perception of pain. All participants have healthy systemic conditions and no active infection in the injection area. Individuals are volunteers to participate in the study. Candidates must be 20 to 60 years old. 20 years 60 years Both Individuals who take drugs that change their perception of pain. Individuals who have an active infection in the injection area. Patients with cardiovascular, respiratory and blood pressure (over 15) diseases. Treatment - Devices Treatment - Devices Treatment - Devices Treatment - Devices Intervention group: Group A: injection of labial infiltration in the anterior of the maxilla parallel to the longitudinal axis of the tooth with a normal syringe - in this group anesthesia, in the form of infiltration, in the apex of the maxillary left central tooth by conventional method or parallel to the longitudinal axis of the tooth using a normal syringe and a 12 mm short needle head of 30 gauge and lidocaine anesthetic agent with epinephrine 1:100000 in the amount of 1.2 ml (approximately equivalent to two thirds of the cartridge) are applied to the patient in the semi-supine position. Intervention group: Group B: labial infiltration injection in the anterior of the maxilla with a new method and angle (α) with a normal syringe - in this group anesthesia, in the form of infiltration, in the apex area of the left central tooth of the maxilla with a new method so that in this method first three anatomical planes (sagittal-occlusal-frontal) are considered. Then, the needle is inserted at an angle α (65 degrees to the sagittal plane or the longitudinal axis of the tooth/35 degrees to the occlusal plane/80 degrees to the frontal plane) in the depth of the mucobuccal fold of the maxillary left central tooth. The injection is applied to the patient in the semi-supine position using a regular syringe and a short needle head of 30 gauge and an anesthetic agent of lidocaine with epinephrine 1:100000 in the amount of two thirds of the cartridge. Intervention group: Group C: labial infiltration injection in the anterior of the maxilla using CCLAD parallel to the longitudinal axis of the tooth - in this group anesthesia, in the form of infiltration, in the apex of the maxillary left central tooth by conventional method or parallel to the longitudinal axis of the tooth using the computerized injection technique and 12 mm short needle head 30 gauge and lidocaine anesthetic agent with epinephrine 1:100000 in the amount of 1.2 ml (approximately equivalent to two thirds of the cartridge) is applied to the patient in the semi-supine position. Intervention group: Group D: Labial infiltration injection in the anterior of the maxilla using CCLAD with a new method and angle (α) - in this group anesthesia, in the form of infiltration, in the apex area of ​​the left central tooth of the maxilla in a new way so that in this method First, three anatomical planes (sagittal-occlusal-frontal) are considered. Then, the needle is inserted at an angle α (65 degrees to the sagittal plane or the longitudinal axis of the tooth/35 degrees to the occlusal plane/80 degrees to the frontal plane) in the depth of the mucobuccal fold of the maxillary left central tooth. The injection is applied to the patient using a computerized injection technique and a 30-gauge short needle head and an anesthetic agent of lidocaine with epinephrine 1:100,000 in the amount of two-thirds of the cartridge in the semi-supine position. The amount of pain after injection. Timepoint: Immediately after injection. Method of measurement: Using a numerical rating scale (NRS 0-10), the pain level is evaluated. This scale has points from 0 to 10 and the patient is asked to specify the level of pain in the index [61]. Blood pressure. Timepoint: Before, during and after injection. Method of measurement: When the patient sits on the dental chair, we wait 10 minutes until the patient's heart rate, blood pressure, and respiratory rate return to normal. Then the vital sign device (CMS 6000 brand made in China) is connected to the patient to measure heart rate, blood pressure and respiratory rate and the patient is monitored. For adults, normal blood pressure is defined as 120/80 (mmHg). After the patient is connected to the vital sign measuring device, blood pressure is recorded before the injection. Then once during the injection and finally immediately after the injection blood pressure is recorded and compared with the initial level. Heart beat. Timepoint: Before, during and after injection. Method of measurement: When the patient sits on the dental chair, we wait 10 minutes until the patient's heart rate, blood pressure, and respiratory rate return to normal. Then the vital sign device (CMS 6000 brand made in China) is connected to the patient to measure heart rate, blood pressure and respiratory rate and the patient is monitored. For adults, a normal heart rate is defined as 80 to 100 beats per minute (bpm). After the patient is connected to the vital sign measuring device, the heart rate is recorded before the injection. Then, once during the injection and finally immediately after the injection, the heart rate is recorded and compared with the initial rate. Respiratory rate. Timepoint: Before, during and after injection. Method of measurement: When the patient sits on the dental chair, we wait 10 minutes until the patient's heart rate, blood pressure, and respiratory rate return to normal. Then the vital sign device (CMS 6000 brand made in China) is connected to the patient to measure heart rate, blood pressure and respiratory rate and the patient is monitored. For adults, normal breathing is defined as 12 to 20 breaths per minute. After the patient is connected to the vital signs measurement device, first before the injection, the respiratory rate is recorded. Then once during the injection and finally immediately after the injection, the respiratory rate is recorded and compared with the initial rate. Mazandaran University of Medical Sciences Approved 2023-01-24 Ethics Committee of Mazandaran University of Medical Sciences Mazandaran University of Medical Sciences headquarters, the beginning of Valiasr highway, Imam Square, Sari Sari Mazandaran Iran (Islamic Republic of)