Investigation Into The Effect of Vitamin B-Complex on Pain Relief And Healing After The Extraction of The Lower Third Molars

This study evaluates Vitamin B-Complex effectiveness on pain and healing after mandibular third molar surgery, comparing active treatment with placebo using a split-mouth design where each patient serves as their own control.

Single-center, randomized, double-blind, placebo-controlled, split-mouth clinical trial with 17 participants (34 sites) using block randomization with allocation concealment.

Single-center trial at a dental school's Oral Surgery Department using a split-mouth design. Double-blinding was maintained with identical Vitamin B-Complex and placebo packaging. Participants, investigators, and outcome assessors were all blinded to treatment assignments throughout the study.

inclusion: Healthy individuals (ASA I status) aged 18 to 35 years requiring surgical extraction of both impacted or semi-impacted mandibular third molars. exclusion: Use of non-steroidal anti-inflammatory drugs within one week prior to surgery; tobacco, alcohol, or illicit drug use; pre-existing infection at third molar sites; known allergy to B vitamin compounds; presence of systemic diseases.

This split-mouth study administers both Vitamin B-Complex and placebo to each participant, with two tablets daily for one week, alongside standardized ibuprofen for pain, to isolate the vitamin's effect while maintaining consistent pain management.

Pain Intensity: Measured using Visual Analogue Scale (VAS) at 1, 6, 12, 24, 48, and 72 hours postoperatively. Wound Healing: Assessed clinically at 2 and 3 weeks post-surgery using three-stage healing scale

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.

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