Effectiveness of topical vacuum assisted drainage in mandibular third molar surgeries: a randomized controlled clinical study.

OBJECTIVE: This study aimed to evaluate the clinical efficacy of intraoral vacuum-assisted drainage (VAD) in reducing postoperative inflammatory complications-pain, swelling, and trismus-following the surgical extraction of impacted mandibular third molars (M3M). MATERIALS AND METHODS: A prospective, randomized, triple-blinded, sham-controlled clinical trial was conducted with 36 systemically healthy participants undergoing surgical removal of a single M3M. Participants were randomly assigned to either the VAD group (n = 18), receiving three sessions of intraoral negative pressure therapy via a custom-made splint, or the sham-control group (n = 18), in which the apparatus was applied without suction. Primary outcomes included pain intensity, facial swelling, and maximum mouth opening (MMO), measured preoperatively and on the 2nd and 7th postoperative days. Secondary outcomes were NSAID consumption and oral health-related quality of life (OHIP-14). Statistical analysis was conducted with a significance level of 0.05. RESULTS: The VAD group showed significantly lower pain scores at all postoperative time points compared to controls (p < 0.05). Swelling was significantly reduced on postoperative day 2 (p = 0.019), and MMO was significantly greater on both postoperative days 2 and 7 (p < 0.001 and p = 0.001, respectively). Nonsteroidal anti-inflammatory drug consumption was significantly lower in the VAD group (8.1 ± 3.2 vs. 12.8 ± 4.6 tablets, p = 0.001), and OHIP-14 scores indicated improved quality of life on postoperative day 7 (p = 0.021). CONCLUSIONS: Within the limitations of this preliminary trial, vacuum-assisted drainage showed potential in reducing early postoperative complications following M3M surgery. These findings support further investigation into its clinical application. CLINICAL RELEVANCE: This study introduces an innovative intraoral vacuum-assisted drainage technique that enhances patient recovery after mandibular third molar surgery. By reducing inflammatory complications and analgesic dependency, it offers a promising adjunct to standard postoperative care, particularly in patients where NSAID use is limited or adverse effects are a concern. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT06758258. Date of Registration 26/11/2024 (retrospectively registered).