Evaluating the Effect of MIIP-E2 Gum on Dental Plaque Over 4 Days Using a Plaque Accumulation Model

What this Trial Is About

Researchers are evaluating the effect of a chewing gum containing an active compound called MIIP-E2 on dental plaque formation using a 4-day plaque accumulation model. This single-blind, randomized controlled trial involves 32 adult subjects who will participate in three treatment periods, each lasting four days. The study compares an active MIIP-E2 gum, a placebo gum without the active compound, and a no-gum control regimen to assess their impact on dental plaque buildup. The trial uses a 3-way crossover design where each participant experiences all three treatments in different sequences, with approximately 10-day washout periods between treatments. During each 4-day treatment period, participants will refrain from oral hygiene practices and use the assigned gum product three times daily for 10 minutes after meals, chewing on each side of the mouth for one minute before chewing freely. Compliance will be monitored using daily diaries. Participants will undergo oral examinations, plaque assessments, saliva sample collections, and intraoral photographs at baseline and after each treatment period. The primary outcome is the amount of dental plaque measured after four days of intervention. Additional assessments include DNA sequencing of oral bacteria and visual plaque evaluations. The study includes safety and compliance checks and lasts through the three treatment periods with washouts in between.

4-day Plaque Accumulation Model Evaluating Compound Containing Gum