Adjunctive Effect of Erythritol on Pocket Closure Rates
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Non-surgical periodontal therapy + sub-gingival air polishing, Non-surgical periodontal therapy alone.
- Who it may be relevant to
- Registry conditions: Periodontitis, Pocket, Periodontal, Pocket, Gingival. Basic parameters: from 35 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Adjunctive Effect of Erythritol on Pocket Closure Rates: RCT
Overview
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.
Interventions
- 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. - Procedure Non-surgical periodontal therapy alone
Participants receive a single session of non-surgical periodontal therapy (NSPT) using ultrasonic and manual instruments.
Primary outcome measures
- Proportion of periodontal pockets with successful pocket closure [Time frame: 2 months and 4 months after treatment]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Italy · 1 center
- University of L'Aquila — L’Aquila
Identifiers
NCT: NCT06958874 · Verb n. 25 del 14/09/22 ABRUZZ