Periodontitis, AdultGBT2017NCT04264624
Efficacy of Sub-gingival Air-polishing With Erythritol in the Treatment of Periodontitis
A study testing Perioflow and Erythritol powder and ultrasonic debridement and Airflow and Erythritol powder and ultrasonic debridement in people with Periodontitis, Adult and Periodontitis, Aggressive, run by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia at 1 site in Italy.
Trial summary
The first step in the management of periodontal disease involves the non-surgical removal of the soft and hard bacterial deposits at all supra- and sub-gingival sites, especially into deep pockets, which can be carried on with different instruments. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Adult, Periodontitis, Aggressive
- What is being tested?
- Perioflow and Erythritol powder and ultrasonic debridement and Airflow and Erythritol powder and ultrasonic debridement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 28 Feb 2018to 10 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signed Informed Consent Form.
- Male and female subjects, aged 18-75 years, inclusive.
- Good general health (free of systemic diseases such as diabetes, HIV infection or genetic disorder, ongoing malignant disease of any type that could influence the outcome of the treatment and might interfere with the evaluation of the study objectives).
- Moderate to severe periodontitis
- At least 8 experimental sites (PD 5-9 mm and BoP+).
- Availability for the 3-month duration of the study for an assigned subject.
Who cannot join
- Presence of orthodontic appliances.
- Chronic obstructive pulmonary disease and asthma.
- Tumors or significant pathology of the soft or hard tissues of the oral cavity.
- Current radiotherapy or chemotherapy.
- Pregnant or lactating women.
- Current or past (within 3 months prior to enrolment) assumption of medications that may influence periodontal conditions and/or interfere with healing following periodontal treatment (i.e., corticosteroids, calcium channel blockers, systemic antibiotics, ...).
Show all 10Show fewer
- History of allergy to Erythritol.
- Restorations on the teeth to be treated which may interfere with treatment administration and/or scoring procedures, at the discretion of the examiner.
- Non-surgical and/or surgical mechanical/manual periodontal debridement within 3 months prior to enrolment.
- Use of systemically administered antibacterial agents to treat periodontal disease or dental prophylaxis within 3 months prior to enrolment.
Trial locations and contacts
1 site in 1 country.
About this study
The first step in the management of periodontal disease involves the non-surgical removal of the soft and hard bacterial deposits at all supra- and sub-gingival sites, especially into deep pockets, which can be carried on with different instruments. Unfortunately it seems that, after the initial therapy, many patients still present with active pockets (residual pockets) requiring further treatment and posing a risk of disease progression. This might be due to limitations of the instruments applied and patient-related factors. Air-polishing with low-abrasiveness powders seems to be very effective in the removal of supra- and sub-gingival biofilm and could provide additional benefits during the treatment of pockets.
The hypothesis of the present randomized controlled trial was that the adjunctive use of a sub-gingival nozzle for air-polishing with erythritol powder in pockets with probing depth of 5-9mm and with bleeding (experimental sites) can bring clinical and microbiological advantages during the active therapy of periodontal disease, and reduce the number of residual pockets.
Read more
To test this hypothesis, the patients, upon initial evaluation, were divided in 2 study groups:
- The control group, undergoing a standard procedure involving air-polishing supra-gingivally and at healthy sub-gingival sites followed by debridement with an ultrasonic scaler at deep pathological pockets
- The study group, undergoing the same procedure but with the additional use of a sub-gingival nozzle at deep pathological pockets.
The healing of the experimental sites and the prevalence of residual pockets will be evaluated at 3 months after the initial therapy and compared between the two groups.
Read the detailed description
OUTCOME
- Primary outcome measure: 3-month change in the number of sites with probing depth (PD) 5-9 mm and positive to bleeding upon probing (BoP). Sites characterized by PD 5-9 mm and BoP+ will be therefore identified as "experimental sites".
- Secondary outcomes: 3-month changes in the following clinical parameters assessed at experimental sites: clinical attachment level (CAL), PD, number of sites harboring supra-gingival plaque.
- Other evaluations: Pocket microbiological (subgingival plaque) samples at one (interproximal) experimental site for analysis of periodontal pathogens at baseline and 3 months following treatment.
STUDY POPULATION Forty (40) adults, aged 18-75 years, will be entered into study (randomized). It is expected that at least thirty-two (32) subjects will complete the study.
Randomized subjects who deviate from the protocol (major protocol deviation) and, for this reason, are excluded from the analysis, will be replaced to guarantee that the sample required for the analysis (32) is reached.
Inclusion Characteristics
- Signed Informed Consent Form.
- Male and female subjects, aged 18-75 years, inclusive.
- Good general health (free of systemic diseases such as diabetes, HIV infection or genetic disorder, ongoing malignant disease of any type that could influence the outcome of the treatment and might interfere with the evaluation of the study objectives).
- Moderate to severe periodontitis
- At least 8 experimental sites (PD 5-9 mm and BoP+).
- Availability for the 3-month duration of the study for an assigned subject.
- Conditions
- Periodontitis, Adult, Periodontitis, Aggressive
- Being tested
- Perioflow and Erythritol powder and ultrasonic debridement, Airflow and Erythritol powder and ultrasonic debridement
- Keywords
- Guided Biofilm Therapy, Periodontitis, Erythritol
- Medical subject headings
- Chronic Periodontitis, Aggressive Periodontitis, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perioflow and Erythritol powder and ultrasonic debridementDevice
Airflow and Perioflow combined with Erythritol powder will be used as an adjunct therapy
Airflow and Erythritol powder and ultrasonic debridementDevice
Airflow combined with Erythritol powder will be used as an adjunct therapy
| Study group | Role | What they receive |
|---|---|---|
| Guided Biofilm Therapy with Perioflow | Experimental | The entire mouth will be treated (supra-/subgingival) in a single session. If the patient has been identified to receive the adjunctive treatment, he/she will also receive subgingival biofilm removal with Perioflow combined with Erythritol powder at sites with PD≥ 5 mm, including the experimental sites, prior to subgingival biofilm removal with USD. Receives: Device: Perioflow and Erythritol powder and ultrasonic debridement; Device: Airflow and Erythritol powder and ultrasonic debridement |
| Guided Biofilm Therapy without Perioflow | Active comparator | The entire mouth will be treated (supra-/subgingival) in a single session. If the patient has been identified to receive the control treatment, all teeth present will receive the application of disclosing agent, full-mouth supragingival and intra-sulcular biofilm removal with Airflow at sites with PD up to 4 mm, full mouth supra gingival calculus removal with USD, and subgingival biofilm removal with USD at sites with PD> 4 mm, including the experimental sites, as required. Receives: Device: Airflow and Erythritol powder and ultrasonic debridement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome measure:3 month and to the end of study ( 1 years)
Sites characterized by PD 5-9 mm and BoP+ will be therefore identified as "experimental sites".
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2020
- Study start28 Feb 2018
- Primary completion5 Oct 2019
- Study completion10 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Periodontitis, AdultStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel-Arm, Examiner-Blinded, RCT
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
- Sponsor type
- University, hospital or other
- Collaborators
- Università degli Studi di Ferrara
- Responsible party
- Principal investigator, Magda Mensi, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
- Investigators
- Magda Mensi, Principal investigator, Asst Degli Spedali Civili Di Brescia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04264624
- Sponsor's protocol ID
- GBT2017
- Acronym
- GBT2017
- Status last verified
- Feb 2020
- First submitted
- 24 Jun 2019
- Last updated
- 18 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mensi M, Caselli E, D'Accolti M, Soffritti I, Farina R, Scotti E, Guarnelli ME, Fabbri C, Garzetti G, Marchetti S, Sordillo A, Trombelli L. Efficacy of the additional use of subgingival air-polishing with erythritol powder in the treatment of periodontitis patients: a randomized controlled clinical trial. Part II: effect on sub-gingival microbiome. Clin Oral Investig. 2023 Jun;27(6):2547-2563. doi: 10.1007/s00784-022-04811-4. Epub 2022 Dec 20.
PubMed 36538094Mensi M, Scotti E, Sordillo A, Calza S, Guarnelli ME, Fabbri C, Farina R, Trombelli L. Efficacy of the additional use of subgingival air polishing with erythritol powder in the treatment of periodontitis patients: a randomized controlled clinical trial. Clin Oral Investig. 2021 Feb;25(2):729-736. doi: 10.1007/s00784-020-03648-z. Epub 2021 Jan 6.
PubMed 33404760
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Sub-gingival Air-polishing With Erythritol in the Treatment of Periodontitis
- ClinicalTrials.gov ID
- NCT04264624
- Acronym / sponsor ID
- GBT2017 / GBT2017
- Conditions
- Periodontitis, Adult, Periodontitis, Aggressive
- Keywords
- Guided Biofilm Therapy, Periodontitis, Erythritol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaUniversity, hospital or other
- Collaborators
- Università degli Studi di Ferrara
- Study start
- 28 Feb 2018 (actual)
- Primary completion
- 5 Oct 2019 (actual)
- Study completion
- 10 Dec 2019 (actual)
- First posted
- 11 Feb 2020 (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.
The first step in the management of periodontal disease involves the non-surgical removal of the soft and hard bacterial deposits at all supra- and sub-gingival sites, especially into deep pockets, which can be carried on with different instruments. Unfortunately it seems that, after the initial therapy, many patients still present with active pockets (residual pockets) requiring further treatment and posing a risk of disease progression. This might be due to limitations of the instruments applied and patient-related factors. Air-polishing with low-abrasiveness powders seems to be very effective in the removal of supra- and sub-gingival biofilm and could provide additional benefits during the treatment of pockets.
The hypothesis of the present randomized controlled trial was that the adjunctive use of a sub-gingival nozzle for air-polishing with erythritol powder in pockets with probing depth of 5-9mm and with bleeding (experimental sites) can bring clinical and microbiological advantages during the active therapy of periodontal disease, and reduce the number of residual pockets.
To test this hypothesis, the patients, upon initial evaluation, were divided in 2 study groups:
- The control group, undergoing a standard procedure involving air-polishing supra-gingivally and at healthy sub-gingival sites followed by debridement with an ultrasonic scaler at deep pathological pockets
- The study group, undergoing the same procedure but with the additional use of a sub-gingival nozzle at deep pathological pockets.
The healing of the experimental sites and the prevalence of residual pockets will be evaluated at 3 months after the initial therapy and compared between the two groups.
Detailed description
OUTCOME
- Primary outcome measure: 3-month change in the number of sites with probing depth (PD) 5-9 mm and positive to bleeding upon probing (BoP). Sites characterized by PD 5-9 mm and BoP+ will be therefore identified as "experimental sites".
- Secondary outcomes: 3-month changes in the following clinical parameters assessed at experimental sites: clinical attachment level (CAL), PD, number of sites harboring supra-gingival plaque.
- Other evaluations: Pocket microbiological (subgingival plaque) samples at one (interproximal) experimental site for analysis of periodontal pathogens at baseline and 3 months following treatment.
STUDY POPULATION Forty (40) adults, aged 18-75 years, will be entered into study (randomized). It is expected that at least thirty-two (32) subjects will complete the study.
Randomized subjects who deviate from the protocol (major protocol deviation) and, for this reason, are excluded from the analysis, will be replaced to guarantee that the sample required for the analysis (32) is reached.
Inclusion Characteristics
- Signed Informed Consent Form.
- Male and female subjects, aged 18-75 years, inclusive.
- Good general health (free of systemic diseases such as diabetes, HIV infection or genetic disorder, ongoing malignant disease of any type that could influence the outcome of the treatment and might interfere with the evaluation of the study objectives).
- Moderate to severe periodontitis
- At least 8 experimental sites (PD 5-9 mm and BoP+).
- Availability for the 3-month duration of the study for an assigned subject.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel-Arm, Examiner-Blinded, RCT
| Arm | Type | Receives |
|---|---|---|
| Guided Biofilm Therapy with Perioflow | Experimental | Device: Perioflow and Erythritol powder and ultrasonic debridement, Device: Airflow and Erythritol powder and ultrasonic debridementThe entire mouth will be treated (supra-/subgingival) in a single session. If the patient has been identified to receive the adjunctive treatment, he/she will also receive subgingival biofilm removal with Perioflow combined with Erythritol powder at sites with PD≥ 5 mm, including the experimental sites, prior to subgingival biofilm removal with USD. |
| Guided Biofilm Therapy without Perioflow | Active comparator | Device: Airflow and Erythritol powder and ultrasonic debridementThe entire mouth will be treated (supra-/subgingival) in a single session. If the patient has been identified to receive the control treatment, all teeth present will receive the application of disclosing agent, full-mouth supragingival and intra-sulcular biofilm removal with Airflow at sites with PD up to 4 mm, full mouth supra gingival calculus removal with USD, and subgingival biofilm removal with USD at sites with PD> 4 mm, including the experimental sites, as required. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Signed Informed Consent Form.
- Male and female subjects, aged 18-75 years, inclusive.
- Good general health (free of systemic diseases such as diabetes, HIV infection or genetic disorder, ongoing malignant disease of any type that could influence the outcome of the treatment and might interfere with the evaluation of the study objectives).
- Moderate to severe periodontitis
- At least 8 experimental sites (PD 5-9 mm and BoP+).
Key exclusion criteria (10 listed)
- Presence of orthodontic appliances.
- Chronic obstructive pulmonary disease and asthma.
- Tumors or significant pathology of the soft or hard tissues of the oral cavity.
- Current radiotherapy or chemotherapy.
- Pregnant or lactating women.
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 |
|---|---|---|
| Perioflow and Erythritol powder and ultrasonic debridementAirflow and Perioflow combined with Erythritol powder will be used as an adjunct therapy | Device | Guided Biofilm Therapy with Perioflow |
| Airflow and Erythritol powder and ultrasonic debridementAirflow combined with Erythritol powder will be used as an adjunct therapy | Device | Guided Biofilm Therapy with Perioflow, Guided Biofilm Therapy without Perioflow |
Primary outcome
Primary outcome measure:3 month and to the end of study ( 1 years)
Time frame: through study completion, an average of 1 year
Sites characterized by PD 5-9 mm and BoP+ will be therefore identified as "experimental sites".
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2020.
- Derived from this study: PubMed 36538094Mensi M, Caselli E, D'Accolti M, Soffritti I, Farina R, Scotti E, Guarnelli ME, Fabbri C, Garzetti G, Marchetti S, Sordillo A, Trombelli L. Efficacy of the additional use of subgingival air-polishing with erythritol powder in the treatment of periodontitis patients: a randomized controlled clinical trial. Part II: effect on sub-gingival microbiome. Clin Oral Investig. 2023 Jun;27(6):2547-2563. doi: 10.1007/s00784-022-04811-4. Epub 2022 Dec 20.
- Derived from this study: PubMed 33404760Mensi M, Scotti E, Sordillo A, Calza S, Guarnelli ME, Fabbri C, Farina R, Trombelli L. Efficacy of the additional use of subgingival air polishing with erythritol powder in the treatment of periodontitis patients: a randomized controlled clinical trial. Clin Oral Investig. 2021 Feb;25(2):729-736. doi: 10.1007/s00784-020-03648-z. Epub 2021 Jan 6.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Magda Mensi principal investigator
Asst Degli Spedali Civili Di Brescia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perioflow and Erythritol powder and ultrasonic debridement and Airflow and Erythritol powder and ultrasonic debridement in people with Periodontitis, Adult and Periodontitis, Aggressive, run by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia 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 6 inclusion and 10 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: finished, as of the sponsor's last update on 18 Feb 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary outcome measure:3 month and to the end of study ( 1 years) (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04264624, which also lists 2 linked publications.
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 18 Feb 2020.