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IRCT20251104067878N1 IRCT 2025-11-07 Islamic Azad University Vitamin B-Complex Effect on Pain of Extraction Investigation Into The Effect of Vitamin B-Complex on Pain Relief And Healing After The Extraction of The Lower Third Molars 2025-11-16 anticipated 17 Complete https://irct.ir/trial/87309 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization process in this study was structured as follows: Method of Randomization: Block Randomization was used. This method ensures a balanced assignment of interventions (e.g., control and intervention) throughout the enrollment period, preventing a situation where one group has significantly more participants than the other at any point. Unit of Randomization: The unit was the surgical site (tooth) within each participant. This is a "split-mouth" design where each patient served as their own control, with one side randomly assigned to the intervention and the other to the control. Randomization Strata: The thesis does not mention the use of stratified randomization. Therefore, no specific patient characteristics (such as age or gender) were used as strata to create balanced groups. Tools Used: The random sequence was generated using computer software (specifically, SPSS or other random allocation software). How the Random Sequence was Built: An independent person (not involved in patient recruitment or outcome assessment) used the computer software to generate a pre-determined, unpredictable random allocation sequence. This sequence dictated which surgical site (left or right) would receive the Vitamin B-Complex and which would receive the placebo for each participant. Allocation Concealment: Yes, allocation concealment was carried out. The intervention and placebo were prepared in identical, coded bottles or containers according to the random sequence. This ensured that the surgeons and investigators enrolling participants could not foresee the upcoming assignment, thus preventing selection bias, Blinding description: In this randomized controlled trial, blinding was implemented for key groups to minimize bias, achieved through the following methods: Participants: Participants were blinded. Both the active drug (Vitamin B-Complex) and the control (placebo) were prepared in identical, indistinguishable capsules. This ensured that participants did not know whether they were receiving the intervention or the placebo for each specific surgical site. Investigators / Healthcare Providers: The principal investigator and healthcare providers involved in administering the interventions were blinded. The randomization codes were pre-generated, and the interventions were packaged and labeled according to these codes. The individuals dispensing the medication capsules had no knowledge of which bottle contained the active drug versus the placebo. Outcome Assessors: The outcome assessors were explicitly blinded. The individual(s) responsible for collecting post-operative data, including pain scores (VAS) and healing assessments, had no information about the group assignment (intervention or control) for each surgical site. Data Collectors: The data collectors, who were responsible for recording the outcomes from the assessments, were the same as the blinded outcome assessors, thus maintaining the blinding throughout this stage. The following groups were not blinded or their blinding status was not specified: Data Analysts: The blinding of the data analyst was not mentioned in the thesis manuscript. Data and Safety Monitoring Board (DSMB): The study did not report the establishment of a DSMB. The blinding was maintained until the data collection for all primary and secondary outcomes was complete. 3 Postoperative sequelae following surgical extraction of impacted or semi-impacted mandibular third molars, specifically focusing on pain management and wound healing complications. The condition involves common postoperative symptoms including acute pain, inflammation, and delayed soft tissue recovery after mandibular third molar surgery. This study examines therapeutic interventions to improve recovery outcomes following this common oral surgical procedure.. Intervention 1: Intervention group: Oral Vitamin B-Complex tablets (2 tablets daily for one week) plus Ibuprofen as needed for pain management. Intervention 2: Control group: Identical placebo tablets (2 tablets daily for one week) plus Ibuprofen as needed for pain management. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Alireza Ramadan
No. 9, 9th Neistan Ave, Pasdaran Street,. Tehran
Tehran Iran (Islamic Republic of) 1946853314 +98 21 8601 3079 alirezarmdn8@gmail.com Islamic Azad University scientific Alireza Ramadan
No. 9, 9th Neistan Ave, Pasdaran Street,. Tehran
Tehran Iran (Islamic Republic of) 1946853314 +98 21 8601 3079 alirezarmdn8@gmail.com Islamic Azad University Iran (Islamic Republic of) Age: Between 18 and 35 years old. Health Status: Classified as ASA I (A normal healthy patient). Dental Condition: Required surgical removal of both left and right impacted or semi-impacted mandibular third molars (lower wisdom teeth). 18 years 35 years Both Medication Use: Had used any non-steroidal anti-inflammatory drugs (NSAIDs) or analgesics in the one week prior to surgery. Substance Use: Were consumers of tobacco, alcohol, or illicit drugs. Pre-existing Infection: Had signs or symptoms of infection related to the third molar in the week before surgery. Allergy: Had a known allergy to compounds in the Vitamin B family. Systemic Diseases: Had any specific systemic diseases (this was asked in the patient information form to screen for ineligible conditions). M27.2 Inflammatory conditions of jaws Treatment - Drugs Treatment - Drugs Intervention group: Oral Vitamin B-Complex tablets (2 tablets daily for one week) plus Ibuprofen as needed for pain management. Control group: Identical placebo tablets (2 tablets daily for one week) plus Ibuprofen as needed for pain management. Postoperative Pain Intensity: Measured using the Visual Analogue Scale (VAS), a 0-10 point scale where 0 represents "no pain" and 10 represents "the worst pain imaginable." Measurements are recorded at 1, 6, 12, 24, 48, and 72 hours after the surgical procedure. Wound Healing Status: Assessed clinically using a three-stage healing scale: 1) No healing (open wound with exposed bone), 2) Minimal healing with mucosal erythema, and 3) Healed with normal mucosa. Evaluations are performed at 2 weeks and 3 weeks post-surgery. Timepoint: Pain Intensity: Measured at 1, 6, 12, 24, 48, and 72 hours after the surgical intervention. Wound Healing Status: Assessed at 2 weeks and 3 weeks after the surgical intervention. Method of measurement: Pain Intensity: Measured using a standardized Visual Analogue Scale (VAS), a 10-cm horizontal line where the left end (0) represents "no pain" and the right end (10) represents "the worst pain imaginable." Patients self-report their pain level by marking a point on the line.Wound Healing Status: Assessed through direct clinical examination by a trained evaluator using a predefined three-stage healing scale based on visual inspection of the surgical site. Islamic Azad University Approved 2023-05-14 Ethics Committee of Dentistry Faculty - Islamic Azad University of Medical Sciences, Tehran No. 9, 9th Neistan, Pasdaran Street Tehran Tehran Iran (Islamic Republic of)