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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NSPT (Control) | Active Comparator | Participants receive standard non-surgical periodontal treatment (scaling and root planing) using ultrasonic and manual instruments in selected periodontal pockets. |
|
| NSPT + ERY (Test) | Experimental | Participants receive standard non-surgical periodontal treatment combined with sub-gingival air polishing using erythritol powder in selected periodontal pockets. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
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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)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of L'Aquila | Recruiting | L’Aquila | 67100 | Italy |
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.
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| ID | Term |
|---|---|
| D010518 | Periodontitis |
| D010514 | Periodontal Pocket |
| D005888 | Gingival Pocket |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D005891 | Gingivitis |
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|
| Non-surgical periodontal therapy alone | Procedure | Participants receive a single session of non-surgical periodontal therapy (NSPT) using ultrasonic and manual instruments. |
|
| D007239 |
| Infections |
| D005882 | Gingival Diseases |