Adjunctive Effect of Erythritol on Pocket Closure Rates

University of L'Aquila

Status: Enrolling

Conditions: Pocket, Gingival; Periodontitis; Pocket, Periodontal

Treatments: Procedure: Non-surgical periodontal therapy alone; Procedure: Non-surgical periodontal therapy + sub-gingival air polishing

Study type: Interventional

Funder types: Other

Identifiers

NCT06958874

Verb n. 25 del 14/09/22 ABRUZZ

Details and patient eligibility

About

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.

Full 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.

Enrollment: 56 estimated patients

Sex: All

Ages: 35+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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56 participants in 2 patient groups

NSPT (Control)

Active Comparator group

Description:

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

Treatment:

Procedure: Non-surgical periodontal therapy alone

NSPT + ERY (Test)

Experimental group

Description:

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

Treatment:

Procedure: Non-surgical periodontal therapy + sub-gingival air polishing