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IRCT20250917067281N1 IRCT 2026-05-18 Yazd University of Medical Sciences Comparison of the Effect of Articaine and Lidocaine in Tooth Extraction of Opioid‑Addicted Patients عنوان طرح (انگلیسی) Comparison of posterior maxillary tooth extraction pain among opium abusers anesthetized with lidocaine VS Articaine: A randomized Clinical trial 2025-06-10 anticipated 36 Recruiting https://irct.ir/trial/87492 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization Method and Allocation Concealment Participants were assigned to two groups using simple randomization. The unit of randomization was the individual participant. The random sequence was generated using SPSS software version 22 (IBM Corp., Armonk, NY, USA), based on a random number table function. To ensure prevention of selection bias, allocation concealment was achieved using sequentially numbered, sealed opaque envelopes (SNOSE). Each envelope contained the allocation determined by the random sequence and was opened only after the participant’s enrollment and consent. The envelopes were identical, opaque, and sealed to prevent foreknowledge of group assignment, ensuring complete concealment until the moment of allocation, Blinding description: In this study, to minimize bias, blinding is implemented at the levels of the patient, pain assessor, and statistical analyst. The study medications (2% lidocaine with 1:80,000 epinephrine and 4% articaine with 1:100,000 epinephrine) are withdrawn from their original cartridges by the treating dentist prior to the patient’s entry into the operatory and transferred into completely identical syringes devoid of any markings or labels. Each syringe is then labeled solely with a code, either “A” or “B.” As all syringes are prepared before the patient enters the treatment room and outside the operatory, patients do not observe the original cartridges or the type of anesthetic agent at any stage. Therefore, patient-level blinding is fully maintained. Blinding at the operator level is not feasible, as the treating dentist directly observes the syringe contents during preparation and must also carefully manage patients who use opioids. Consequently, the operator is aware of the type of anesthetic administered. Pain assessment at 5, 10, and 30 minutes following tooth extraction is performed by an independent assessor who is unaware of the injected anesthetic agent and the patient’s allocation group. The assessor records pain intensity using only the patient identification code and the Visual Analog Scale (VAS). The statistical analyst has access exclusively to coded data labeled “A” or “B” and is unaware of the actual drug identity or patient information. Unblinding is conducted solely by the principal investigator after completion of the statistical analysis. Accordingly, blinding is fully maintained at the levels of the patient, pain assessor, and statistical analyst until the conclusion of data analysis. N/A عنوان طرح (انگلیسی) Comparison of posterior maxillary tooth extraction pain among opium abusers anesthetized with lidocaine VS Articaine: A randomized Clinical trial. Intervention 1: :::writingOne cartridge of 4% articaine hydrochloride with 0.002% epinephrine was administered via infiltration anesthesia (0.6–1.0 mL in the buccal mucosa and 0.2–0.3 mL in the palatal mucosa) in a patient with smokeless tobacco addiction. The anesthetic solution used in this study was manufactured by Exir Pharmaceutical Company, Iran. Intervention 2: :::writingOne cartridge containing 20 mg of lidocaine hydrochloride and 12.5 µg of epinephrine (as bitartrate) was administered via infiltration anesthesia (0.6–1.0 mL in the buccal mucosa and 0.2–0.3 mL in the palatal mucosa) in a patient with smokeless tobacco addiction. The anesthetic solution used in this study was manufactured by Loghman Pharmaceutical Company, Iran. Yes - There is a plan to make this available What will be shared: “All data can potentially be shared after individuals are de‑identified.” When: “All data can potentially be shared after individuals are de‑identified.” To whom: “Our data will be available only to researchers affiliated with academic and scientific institutions.” Conditions: “If you require access to the results, please send a message to i.tavakolihosseini@ssu.ac.ir or Kiank1381@yahoo.com Or AlirezaRajol7720@gmail.com. Descriptive data will be reported as mean (with standard deviation), and demographic data will be presented as percentages. Statistical analyses will be performed using SPSS software (version 25). The Student’s t‑test will be used to compare whether the difference in pain levels between the two groups at the first 5 and 10 minutes is statistically significant. In addition, the significance of differences in pain changes (between the two pain assessment time points) between the intervention and control groups will be evaluated using a paired t‑test. The significance of differences in patients’ vital signs in both groups, recorded 30 minutes after tooth extraction, will also be assessed using a paired t‑test. Any use of the data from this study for research projects is permitted. Upon registration of a research proposal, it will be possible to submit a request for access to the results of the present study.” Where to obtain: If you require access to the results, please send a message to i.tavakolihosseini@ssu.ac.ir or Kiank1381@yahoo.com Or AlirezaRajol7720@gmail.com. How to obtain: To write a sample request for access to research results, the following points should be considered: Format: A formal and professional letter or email. Content: A brief introduction of the requester, the purpose of the request, a clear description of the required data or documents, a commitment to ethical principles (such as confidentiality and proper citation), and a specific request regarding the expected timeframe for receiving the data. Structure: Title, salutation, main body, expression of thanks, and signature. Based on your preference for conciseness and the use of abbreviations, the following text has been prepared in a compact and clearly structured format. Sample Request for Access to Research Results Subject: Request for Access to Research Data and Documentation Recipient: [Name of the Corresponding Author or Relevant Institution] Text: Dear Sir/Madam, I am [Your Full Name], [your academic position, e.g., Postdoctoral Researcher at University X]. I am currently conducting research in the field of [general research topic], which is closely related to your valuable work entitled “[Title of Your Article].” Purpose of the request: To complete comparative analyses and validate my findings, I kindly request access to the raw data and supplementary materials published with your article. Request details: Required data: Main dataset file(s) (CSV/Excel format). Documentation: Analysis codes (R/Python scripts) and any questionnaires or data collection protocols. Use: Exclusively for research purposes and in full compliance with ethical principles. Commitments: Ensuring data confidentiality. Proper citation of your article in any future publications. No data sharing with third parties without written permission. Timeline request: I would appreciate it if you could inform me of the approximate time required to review the request and provide the files. Typically, I expect this process to take no more than 10–14 working days. Thank you for your time and cooperation. Sincerely, [Your Full Name] [Email] [Institutional Affiliation] Comments:
public Iman Tavakolihosaini
Yazd Province, Yazd, Dah-e-Fajr, W97M+8RF
Yazd Iran (Islamic Republic of) 8914881167 +98 35 3620 4760 i.tavakolihosseini@ssu.ac.ir Yazd University of Medical Sciences scientific Iman Tavakolihosaini
Yazd Province, Yazd, Dah-e-Fajr, W97M+8RF
Yazd Iran (Islamic Republic of) 8914881167 +98 35 3620 4760 i.tavakolihosseini@ssu.ac.ir Yazd University of Medical Sciences Iran (Islamic Republic of) Participants in both groups must be over 18 years of age, and only extraction of their posterior maxillary teeth—excluding third molars—will be performed for inclusion in the study. All individuals with moderate to severe opioid addiction, as determined by the DSM‑5 questionnaire, are eligible for inclusion in the control group. Pregnant women may participate only if they are in the second trimester and possess medical consultation approval. If a patient presents with an abscess, drainage will be performed and, if antibiotic therapy is required, tooth extraction will be postponed until infection resolution. If the patient has periodontitis, extraction will be carried out only after appropriate antibiotic and periodontal therapy. 18 years no limit Both Patients with severe periapical inflammation—without abscess formation but with marked tenderness to percussion—will be excluded from the study. Patients with bleeding disorders will be excluded. Patients undergoing radiotherapy or chemotherapy will be excluded from the study. Postmenopausal women are excluded due to the naturally increased sensitivity to pain stimuli. Patients with herpetic lesions will not be included until complete healing has occurred. Patients whose tooth extraction requires surgical procedures, as well as those who have taken antihistamines within 8 hours or NSAIDs within 6 hours prior to the appointment, will be excluded. Patients requiring surgical tooth extraction will be excluded from the study. Additionally, those in the first or third trimester of pregnancy, patients with diabetes, and individuals with debilitating or uncontrolled systemic diseases will not be included. Treatment - Surgery Treatment - Surgery :::writingOne cartridge of 4% articaine hydrochloride with 0.002% epinephrine was administered via infiltration anesthesia (0.6–1.0 mL in the buccal mucosa and 0.2–0.3 mL in the palatal mucosa) in a patient with smokeless tobacco addiction. The anesthetic solution used in this study was manufactured by Exir Pharmaceutical Company, Iran. :::writingOne cartridge containing 20 mg of lidocaine hydrochloride and 12.5 µg of epinephrine (as bitartrate) was administered via infiltration anesthesia (0.6–1.0 mL in the buccal mucosa and 0.2–0.3 mL in the palatal mucosa) in a patient with smokeless tobacco addiction. The anesthetic solution used in this study was manufactured by Loghman Pharmaceutical Company, Iran. Pain Assessment After Tooth Extraction Using the Visual Analog Scale (VAS). Timepoint: At 5 and 10 minutes after tooth extraction. Method of measurement: Use of the Visual Analog Scale (VAS). Comparison of Vital Signs (Systolic Blood Pressure, Diastolic Blood Pressure, SpO₂, Heart Rate). Timepoint: 30 minutes after tooth extraction. Method of measurement: By means of a Pulse Oximeter. Yazd University of Medical Sciences Approved 2025-05-20 Ethics committee of Shahid Sadoughi University of Dentistry Yazd Province, Yazd, Dah-e-Fajr, W97M+8RF Yazd Yazd Iran (Islamic Republic of)