PeriodontitisNCT06958874
Adjunctive Effect of Erythritol on Pocket Closure Rates
A study testing Non-surgical periodontal therapy + sub-gingival air polishing and Non-surgical periodontal therapy alone in people with Periodontitis and Pocket, Periodontal, run by University of L'Aquila at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Periodontitis, Pocket, Periodontal, Pocket, Gingival
- What is being tested?
- Non-surgical periodontal therapy + sub-gingival air polishing and Non-surgical periodontal therapy alone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteItaly
- Study dates
- 8 Nov 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
University of L'Aquila
L’Aquila, 67100
Davide Pietropaoli, DDS, PhD, 00390862434703, davide.pietropaoli@univaq.it
About this study
Official title: Adjunctive Effect of Erythritol on Pocket Closure Rates: RCT
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.
Read the 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.
- Conditions
- Periodontitis, Pocket, Periodontal, Pocket, Gingival
- Being tested
- Non-surgical periodontal therapy + sub-gingival air polishing, Non-surgical periodontal therapy alone
- Medical subject headings
- Periodontitis, Periodontal Pocket, Gingival Pocket
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-surgical periodontal therapy + sub-gingival air polishingProcedure or surgery
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.
Non-surgical periodontal therapy aloneProcedure or surgery
Participants receive a single session of non-surgical periodontal therapy (NSPT) using ultrasonic and manual instruments.
| Study group | Role | What they receive |
|---|---|---|
| NSPT (Control) | Active comparator | Participants receive standard non-surgical periodontal treatment (scaling and root planing) using ultrasonic and manual instruments in selected periodontal pockets. Receives: 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. Receives: Procedure: Non-surgical periodontal therapy + sub-gingival air polishing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 months and 4 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2025
- Study start8 Nov 2024
- Primary completion31 Mar 2025
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of L'Aquila
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Davide Pietropaoli, University of L'Aquila
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06958874
- Sponsor's protocol ID
- Verb n. 25 del 14/09/22 ABRUZZ
- Status last verified
- Apr 2025
- First submitted
- 19 Apr 2025
- Last updated
- 6 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjunctive Effect of Erythritol on Pocket Closure Rates: RCT
- ClinicalTrials.gov ID
- NCT06958874
- Acronym / sponsor ID
- Verb n. 25 del 14/09/22 ABRUZZ
- Conditions
- Periodontitis, Pocket, Periodontal, Pocket, Gingival
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- University of L'AquilaUniversity, hospital or other
- Study start
- 8 Nov 2024 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 6 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NSPT (Control) | Active comparator | Procedure: Non-surgical periodontal therapy aloneParticipants receive standard non-surgical periodontal treatment (scaling and root planing) using ultrasonic and manual instruments in selected periodontal pockets. |
| NSPT + ERY (Test) | Experimental | Procedure: Non-surgical periodontal therapy + sub-gingival air polishingParticipants receive standard non-surgical periodontal treatment combined with sub-gingival air polishing using erythritol powder in selected periodontal pockets. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-surgical periodontal therapy + sub-gingival air polishingParticipants 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 or surgery | NSPT + ERY (Test) |
| Non-surgical periodontal therapy aloneParticipants receive a single session of non-surgical periodontal therapy (NSPT) using ultrasonic and manual instruments. | Procedure or surgery | NSPT (Control) |
Primary outcome
Proportion of periodontal pockets with successful pocket closure
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2025.
- Individual participant dataSharing planned: Undecided. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-surgical periodontal therapy + sub-gingival air polishing and Non-surgical periodontal therapy alone in people with Periodontitis and Pocket, Periodontal, run by University of L'Aquila at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of periodontal pockets with successful pocket closure (time frame: 2 months and 4 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2025.