Adjunctive Effect of Erythritol on Pocket Closure Rates

Adjunctive Effect of Erythritol on Pocket Closure Rates: RCT

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.

Study Overview

• Status: Recruiting
• Conditions: Periodontitis; Pocket, Periodontal; Pocket, Gingival
• Intervention / Treatment: Procedure: Non-surgical periodontal therapy alone; Procedure: Non-surgical periodontal therapy + sub-gingival air polishing

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 Type: Interventional
• Enrollment (Estimated): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • L'Aquila, Italy, 67100
    • Recruiting
    • University of L'Aquila
    • Contact: Davide Pietropaoli, DDS, PhD; Phone Number: 00390862434703; Email: davide.pietropaoli@univaq.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: NSPT (Control); Participants receive standard non-surgical periodontal treatment (scaling and root planing) using ultrasonic and manual instruments in selected periodontal pockets.	Procedure: Non-surgical periodontal therapy alone; Participants receive a single session of non-surgical periodontal therapy (NSPT) using ultrasonic and manual instruments.
Experimental: NSPT + ERY (Test); Participants receive standard non-surgical periodontal treatment combined with sub-gingival air polishing using erythritol powder in selected periodontal pockets.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of periodontal pockets with successful pocket closure	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.	2 months and 4 months after treatment

Collaborators and Investigators

• Sponsor: University of L'Aquila

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2024
• Primary Completion (Actual): March 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: April 19, 2025
• First Submitted That Met QC Criteria: April 25, 2025
• First Posted (Actual): May 6, 2025

Study Record Updates

• Last Update Posted (Actual): May 6, 2025
• Last Update Submitted That Met QC Criteria: April 25, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases; Gingivitis; Periodontitis; Periodontal Pocket; Gingival Pocket
• Other Study ID Numbers: Verb n. 25 del 14/09/22 ABRUZZ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: It has not yet been determined whether individual participant data (IPD) will be shared. The decision will depend on institutional policies, data privacy considerations, and future research collaborations.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No