عنوان طرح (انگلیسی) Comparison of posterior maxillary tooth extraction pain among opium abusers anesthetized with lidocaine VS Articaine: A randomized Clinical trial

If Articaine proves statistically and clinically superior to Lidocaine in controlling pain among patients, it will enhance treatment quality and reduce additional anesthetic use, leading to cost savings in dental practice and overall healthcare.

A randomized, double‑blind, controlled clinical trial with parallel groups conducted on 36 patients. Randomization was performed using SPSS software.

Eligible patients, after signing informed consent, are randomized into two groups using a random number table generated by SPSS 2022. To maintain blinding of the statistician, all patient data are coded and delivered to the analyst using random numerical identifiers. Patients are then referred, according to the randomization protocol, to a single dentist who performs all extractions. Pain intensity and anesthetic duration are assessed at 5 and 10 minutes after extraction, and vital signs (systolic BP, diastolic BP, SpO₂, heart rate) are measured 30 minutes post‑extraction.

Inclusion: Age >18 years Moderate or severe opioid use disorder Exclusion: Surgical extraction First or third trimester pregnancy Uncontrolled diabetes or other uncontrolled systemic diseases Antihistamine use within 8 h or NSAID use within 6 h before visit Herpetic lesions Postmenopausal women History of radiotherapy or chemotherapy Bleeding disorders Abscess Periodontitis Severe periapical inflammation

Intervention group: Local anesthesia with Articaine Control group: Local anesthesia with Lidocaine

Pain intensity , Blood oxygen saturation (SpO₂), Diastolic blood pressure ,Systolic blood pressure

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.

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.

“All data can potentially be shared after individuals are de‑identified.”

“All data can potentially be shared after individuals are de‑identified.”

“Our data will be available only to researchers affiliated with academic and scientific institutions.”

“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.”

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.

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]