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

This study aims to compare the analgesic effects of the Inferior Alveolar Nerve Block (IANB) and local infiltration anesthesia using 2% lidocaine in mandibular posterior implant surgery.

This study was a randomized, double-blind, parallel-group clinical trial with a split-mouth design. A total of 31 patients are going to be enrolled and undergo bilateral mandibular implant surgeries during a single session. Randomization was performed using block randomization (blocks of 4) generated by Excel software.

The study will be conducted at the implant sector of the School of Dentistry, Tehran University of Medical Sciences. Patients and the evaluators will be blinded to the type of anesthesia administered. However, the statistician and the surgeon will not be blinded due to their roles in randomization and surgical procedures.

Inclusion Criteria: Systemically healthy adults (≥18 years). Candidates for bilateral implant placement in first/second molars. Fully healed/adequately reconstructed alveolar ridge at surgical site. Exclusion Criteria: Systemic contraindications to surgery. Untreated periodontal disease. Medications affecting pain perception within 48 hours of surgery. Pathological conditions at the injection site. Immediate implant placement or requiring bone grafting. Dental anxiety/phobia, neurological disorders, familiarity with injection techniques (e.g., dental professionals).

Group 1: half of the mouth is anesthetized by Inferior Alveolar Nerve Block (IANB) using 2% lidocaine with 1:100,000 epinephrine Group 2: The other half of the mouth is anesthetized by local infiltration using 2% lidocaine with 1:100,000 epinephrine

The primary outcome variable will be the pain intensity during surgery and 24 hours post-surgery, measured using the Visual Analogue Scale (VAS).

randomization conducted using block randomization (blocks of 4), generated by Excel software.

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.

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.

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

Researchers who are affiliated with recognized academic institutions. Healthcare policymakers and practitioners working in the field. Industry researchers, upon providing justified scientific use cases.

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.

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

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.

All shared data will be fully anonymized to protect participant confidentiality. Certain datasets may be restricted due to consent limitations or local regulations.