Periodontitis, Pocket, Gingival, Pocket, Periodontal
Conditions
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.
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
PROCEDURENon-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.
PROCEDURENon-surgical periodontal therapy alone
Participants receive a single session of non-surgical periodontal therapy (NSPT) using ultrasonic and manual instruments.
Sponsors
University of L'Aquila
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of periodontal pockets with successful pocket closure | 2 months and 4 months after treatment | 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. |
Countries
Italy
Outcome results
None listed