Adjunctive Effect of Erythritol on Pocket Closure Rates

Not Applicable

Recruiting

• Conditions: Periodontitis; Pocket, Periodontal; Pocket, Gingival

• Registration Number: NCT06958874
• Lead Sponsor: University of L'Aquila

Brief 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.

Study Timeline

• Study Start: 2024-11-08
• Primary Completion: 2025-03-31
• Status Verified: 2025-04
• Study First Submitted: 2025-04-19
• Study First Submitted QC: 2025-04-25
• Last Update Submitted: 2025-04-25
• Study First Posted: 2025-05-06
• Last Update Posted: 2025-05-06
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

Adults aged 18 years or older

Diagnosed with stage 3 or 4 periodontitis according to the 2017 classification

Presence of at least 12 natural teeth

Presence of periodontal pockets with probing depth ≥ 4 mm in non-adjacent teeth

Good general health or stable systemic conditions (e.g., controlled diabetes)

Exclusion Criteria

Use of antibiotics or anti-inflammatory drugs within 3 months prior to treatment

Periodontal treatment in the previous 6 months

Pregnancy or breastfeeding

Current smokers of more than 10 cigarettes per day

Allergies or intolerance to erythritol or any materials used in the treatment

Systemic diseases or conditions that could influence periodontal healing (e.g., uncontrolled diabetes, immunodeficiency)

Use of medications known to affect periodontal tissues (e.g., phenytoin, cyclosporine, calcium channel blockers)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Proportion of periodontal pockets with successful pocket closure	2 months and 4 months after treatment	Percentage of treated periodontal pockets (with baseline probing depth ≥ 4 mm) that reach pocket closure, defined as probing pocket depth ≤ 4 mm without bleeding on probing, or ≤ 3 mm, at follow-up.

Trial Locations

Locations (1)

University of L'Aquila; 🇮🇹 L'Aquila, Italy