Adjunctive Effect of Erythritol on Pocket Closure Rates

NCT ID: NCT06958874

Last Updated: 2025-05-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-08
• Study Completion Date: 2025-12-31

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.

Conditions

Periodontitis; Pocket, Periodontal; Pocket, Gingival

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

NSPT (Control)

Participants receive standard non-surgical periodontal treatment (scaling and root planing) using ultrasonic and manual instruments in selected periodontal pockets.

Group Type: ACTIVE_COMPARATOR

Non-surgical periodontal therapy alone

Intervention Type: PROCEDURE

Participants receive a single session of non-surgical periodontal therapy (NSPT) using ultrasonic and manual instruments.

NSPT + ERY (Test)

Participants receive standard non-surgical periodontal treatment combined with sub-gingival air polishing using erythritol powder in selected periodontal pockets.

Group Type: EXPERIMENTAL

Non-surgical periodontal therapy + sub-gingival air polishing

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Non-surgical periodontal therapy alone

Participants receive a single session of non-surgical periodontal therapy (NSPT) using ultrasonic and manual instruments.

Intervention Type: PROCEDURE

Eligibility Criteria

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)

• Minimum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of L'Aquila

OTHER

Sponsor Role: lead

Responsible Party

Davide Pietropaoli

DDS, PhD, Associate Professor of Dentistry (PI)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of L'Aquila

L’Aquila, , Italy

Site Status: RECRUITING

Countries

Italy

Facility Contacts

Davide Pietropaoli, DDS, PhD

Role: primary

davide.pietropaoli@univaq.it

00390862434703

Other Identifiers

Verb n. 25 del 14/09/22 ABRUZZ

Identifier Type: -

Identifier Source: org_study_id