Adjunctive Effect of Erythritol on Pocket Closure Rates

NCT06958874 | Recruiting DMC

• 1 other identifier: Verb n. 25 del 14/09/22 ABRUZZ
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontitis; Pocket, Periodontal; Pocket, Gingival

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

NSPT (Control)

ACTIVE COMPARATOR

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

NSPT + ERY (Test)

EXPERIMENTAL

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

Interventions

Non-surgical periodontal therapy + sub-gingival air polishing 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.

NSPT + ERY (Test)

Non-surgical periodontal therapy alone PROCEDURE

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

NSPT (Control)

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of L'Aquila: lead

Study Sites (1)

University of L'Aquila

L’Aquila, 67100, Italy

RECRUITING

MeSH Terms

Conditions

Periodontitis; Periodontal Pocket; Gingival Pocket

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Gingivitis; Infections; Gingival Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DDS, PhD, Associate Professor of Dentistry (PI)

Study Record Dates

• First Submitted: April 19, 2025
• First Posted: May 6, 2025
• Study Start: November 8, 2024
• Primary Completion: March 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 6, 2025

Record last verified: 2025-04

Locations

IT (1)