Actively Recruiting
Adjunctive Effect of Erythritol on Pocket Closure Rates: Randomized Controlled Trial
Led by University of L'Aquila · Updated on 2025-05-06
56
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether adding erythritol powder during non-surgical periodontal treatment (deep cleaning) can improve gum health in people with advanced periodontitis (stage 3 or 4). The study focuses on individuals with deep gum pockets of 4 mm or more and aims to see if erythritol helps with healing, bleeding, plaque levels, and gum attachment compared to standard treatment alone. The trial is randomized and led by the University of L'Aquila. Participants receive either standard non-surgical periodontal therapy, which involves scaling and root planing with ultrasonic and manual instruments, or the same treatment combined with sub-gingival air polishing using erythritol powder. Each participant undergoes a single treatment session targeting periodontal pockets of at least 4 mm in depth on non-adjacent teeth. During the study, researchers measure the proportion of gum pockets that successfully close at 2 and 4 months after treatment. They also track bleeding, plaque levels, and gum attachment to assess periodontal health. Factors such as age, sex, smoking status, and diabetes are monitored to understand how they may affect treatment response. Participation involves clinical evaluations and periodontal assessments over the study period ending in late 2025.
CONDITIONS
Brief Title
Adjunctive Effect of Erythritol on Pocket Closure Rates
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 2 4 mm in non-adjacent teeth
- Good general health or stable systemic conditions (e.g., controlled diabetes)
You will not qualify if you...
- 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)
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single treatment session
Participants receive a single session of non-surgical periodontal therapy using ultrasonic and manual instruments. Some participants also receive additional sub-gingival air polishing with erythritol powder on selected periodontal pockets.
1 treatment visit (in-person)
Duration - 4 months
Participants are monitored to assess improvements in gum pocket depth and other periodontal health indicators after treatment.
2 follow-up visits at 2 months and 4 months (in-person)
Trial Site Locations
Total: 1 location
1
University of L'Aquila
L’Aquila, Italy, 67100
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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