NCT06958874

Adjunctive Effect of Erythritol on Pocket Closure Rates

Adjunctive Effect of Erythritol on Pocket Closure Rates: RCT

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: University of L'Aquila · Academic / Other
• Sex: All
• Age: 35 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial is studying whether using erythritol powder during non-surgical periodontal treatment (deep cleaning) helps improve gum health in people with severe periodontitis. Participants with deep gum pockets (4 mm or more) receive standard treatment alone or standard treatment plus cleaning with erythritol powder. The goal is to evaluate if adding erythritol improves outcomes such as healing of gum pockets, bleeding, plaque levels, and gum attachment compared to standard treatment alone.

Detailed description

This study is testing whether erythritol powder, used during non-surgical periodontal treatment (also known as deep cleaning), can help improve gum health in people with advanced periodontitis (stage 3 or 4). Periodontitis is a serious gum infection that damages the soft tissue and bone supporting the teeth. Standard treatment includes removing plaque and tartar using manual tools or ultrasonic devices. In this study, gum pockets that are 4 mm deep or more are treated either with standard care alone or with standard care plus a cleaning method that uses air pressure and erythritol powder (a sugar alcohol with antibacterial properties). The goal is to determine whether this additional step leads to improved clinical outcomes. Participants are randomly assigned to one of the two treatments. The study tracks improvements in gum pocket depth after 2 and 4 months, as well as other indicators of periodontal health like bleeding and plaque levels. Researchers are also evaluating whether factors such as age, sex, smoking status, or diabetes influence treatment response.

Conditions

• Periodontitis
• Pocket, Periodontal
• Pocket, Gingival

Interventions

Type	Name	Description
PROCEDURE	Non-surgical periodontal therapy + sub-gingival air polishing	Participants receive a single session of non-surgical periodontal therapy (NSPT) using ultrasonic and manual instruments, combined with sub-gingival air polishing using erythritol powder. The treatment is applied to periodontal pockets with probing depth ≥ 4 mm in non-adjacent teeth.
PROCEDURE	Non-surgical periodontal therapy alone	Participants receive a single session of non-surgical periodontal therapy (NSPT) using ultrasonic and manual instruments.

Timeline

• Start date: 2024-11-08
• Primary completion: 2025-03-31
• Completion: 2025-12-31
• First posted: 2025-05-06
• Last updated: 2025-05-06

Locations

1 site across 1 country: Italy