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IRCT20250429065518N1 IRCT 2025-05-22 Office of the Research Deputy, School of Dentistry, Tehran University of medical Sciences Comparison of Analgesic Effect of Inferior Alveolar Nerve Block and Lidocaine Infiltration in Posterior Mandibular Implant Placement: A Split-Mouth Randomized Clinical Trial Effectiveness of Inferior Alveolar Nerve Block Versus Local Infiltration with 2% Lidocaine for Pain Management in Posterior Mandible Implant Surgery: A Randomized Double-Blind Controlled Trial 2024-12-21 anticipated 40 Complete https://irct.ir/trial/83192 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: randomization conducted using block randomization (blocks of 4), generated by Excel software, Blinding description: In this process, the patients and the evaluator responsible for assessing the pain are blinded to the contents of the envelopes. The statistician responsible for the randomization process and the surgeon performing the procedure could not be blinded. However, the patient and the evaluator responsible for assessing the patient’s pain are blinded and do not know which injection is performed on each side. N/A implant placement in the posterior region of Mandible. Intervention 1: The randomly selected hemi-mandible is going to be anesthetized using the IANB technique. Intervention 2: Control group: The randomly selected hemi-mandible is going to be anesthetized using the infiltration technique. Yes - There is a plan to make this available What will be shared: Comparison of Analgesic Effect of Inferior Alveolar Nerve Block and Lidocaine Infiltration in Posterior Mandibular Implant Placement: A Split-Mouth Randomized Clinical Trial The following data/documents will be shared: De-identified Individual Participant Data (IPD): Includes demographic information, procedural data, pain scores (VAS), and outcomes related to anesthesia techniques. Study Protocol Document: Encompasses the experimental design, ethical approvals, and statistical analysis methods. Thesis and Article Files: Includes the complete thesis and the final published article documenting the study. Consent Forms: Translated versions of patient information sheets and consent forms, upon qualified request. When: The data/documents will be available 6 months after the publication of the main study results. The availability period will last for an indefinite period To whom: Researchers who are affiliated with recognized academic institutions. Healthcare policymakers and practitioners working in the field. Industry researchers, upon providing justified scientific use cases. Conditions: To access the shared data/documents, applicants must: Submit a research proposal outlining intended analyses (e.g., secondary analyses, meta-analyses, validation studies). Agree to use the data ethically and responsibly, adhering to participant confidentiality standards. Allow publications to include only aggregate-level data, ensuring non-identifiable results. All requests will be reviewed by the research team and ethics committee, granting access based on scientific merit. Where to obtain: Applicants can request data/documents by contacting: Contact Person: Dr. Nima Dehghani – Corresponding Author Email: nimadt2002@gmail.com Postal Address: Department of Oral and Maxillofacial Surgery, Tehran University of Medical Sciences, School of Dentistry, Postal Code: 1439955991 Phone: +9821-22273471 Fax: +9821-88497390 How to obtain: Submit a formal request including: Research Proposal Intended Data Use Administrative and ethical review conducted by: Research team and ethics committee Sign a Data Use Agreement confirming compliance with ethical guidelines. The review process typically takes 2–4 weeks after receiving all required documents. Comments: All shared data will be fully anonymized to protect participant confidentiality. Certain datasets may be restricted due to consent limitations or local regulations.
public Nima Dehghani
No 121, 9th boostan st., Pasdaran alley
Tehran Iran (Islamic Republic of) 1439955991 +98 21 2279 7274 nimadt2002@gmail.com Tehran University of Medical Sciences scientific Nima Dehghani
No 121, 9th boostan st., Pasdaran alley
Tehran Iran (Islamic Republic of) 1439955991 +98 21 2279 7274 nimadt2002@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Eligible patients were aged 18 or older. Systemically healthy Candidates for bilateral implant surgery in the first or second molar region It was essential that the alveolar ridge in the surgical site had fully healed and reconstructed adequately. 28 years 69 years Both Patients with systemic conditions contraindicating surgery or an allergy to local anesthetics. Pregnant individuals Heavy smokers Individuals suffering from untreated periodontal conditions. Patients who had taken medications affecting pain perception (such as analgesics, antidepressants, or sedatives) within 48 hours prior to surgery. Individuals with active pathological conditions at the injection site. Cases requiring immediate implant placement. Cases needing bone grafting. Individuals suffering from extreme dental anxiety or phobia, or neurological disorders. Individuals who were familiar with the distinct injection techniques (e.g., dental professionals). Z96.5 Presence of tooth-root and mandibular implants Treatment - Surgery Treatment - Surgery The randomly selected hemi-mandible is going to be anesthetized using the IANB technique. Control group: The randomly selected hemi-mandible is going to be anesthetized using the infiltration technique. The primary outcome variable is pain intensity during surgery and 24 hours after surgery. Pain intensity was assessed using the Visual Analogue Scale (VAS). Timepoint: Pain intensity will be measured during the surgery and at 24 hours post-surgery. Method of measurement: Pain intensity will be measured using the Visual Analogue Scale (VAS). Office of the Research Deputy, School of Dentistry, Tehran University of medical Sciences Approved 2021-07-25 Ethics Committee at Tehran University of Medical Science Secretariat of the Ethics Committee in Biomedical Research, Tehran University - Keshavarz Boulevard - Qods Street Intersection - Central Building of Tehran University of Medical Sciences - 6th Floor - Room 604 Tehran Tehran Iran (Islamic Republic of)