Periodontitis, AggressiveERISRPNCT05112471
Efficacy of GBT vs SRP+US, in the Treatment of Severe Generalized Periodontitis.
A study testing Airflow, Perioflow and Erythritol powder and ultrasonic debridement and Ultrasonic debridement and curettes in people with Periodontitis, Aggressive and Periodontal Diseases, 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, Aggressive, Periodontal Diseases, Periodontitis
- What is being tested?
- Airflow, Perioflow and Erythritol powder and ultrasonic debridement and Ultrasonic debridement and curettes
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteItaly
- Study dates
- 22 Nov 2016to 4 Apr 2020
- 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, with diagnosis of severe generalized periodontitis.
- 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).
- Diagnosis of Stage III-IV periodontitis;
- At least 6 sites per quadrant with Pocket Probing Depth (PPD) ≥ 3mm;
- At least 5 teeth per quadrant;
- Availability for the 3-month duration of the study for an assigned subject.
Who cannot join
- Severe Smoking more than 10 cigarettes per day
- Pregnancy or nursing.
- Radiotherapy or Chemotherapy.
- BPCO (chronic obstructive pulmonary disease), asma.
- Systemic long-term corticosteroid treatment.
- Antibiotic treatment in the period of 3 months before the start of the study.
- Non surgical therapy in the period of 3 months before the start of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Combined Air-abrasive+Ultrasonic (Guided Biofilm Therapy GBT) vs. Standard Root Debridement (Scaling and Root Planing+ Ultrasonic SRP+US) in the Treatment of Severe Generalized Periodontitis: A Randomized Clinical Trial
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.
Read more
The aim of this randomized, controlled, split-mouth study was to compare the efficacy of full-mouth air-polishing followed by ultrasonic debridement (GBT) versus traditional Scaling and Root Planing (SRP), in terms of pocket closure in patients with stage III-IV periodontitis.
To test this hypothesis, the mouth of each patients, upon initial evaluation, were divided in 2 parts:
- The control group undergoing a standard procedure: ultrasonic debridement with an ultrasonic scaler for remove supra and sub gingival calculus, manual debridement with curettes at deep pathological pockets (PPD > 4mm) and rubber cup with polishing to remove supra gingival biofilm and plaque.
- The study group undergoing the innovative air polishing procedure: airflow with erythritol powder to remove supra and sub gingival biofilm and plaque, perioflow at deep pathological pockets (PPD > 4mm) and ultrasonic debridement with an ultrasonic scaler for remove supra and sub gingival calculus.
The prevalence of residual pockets will be evaluated at 6 weeks and 3 months after the initial therapy and compared between the two groups.
Read the detailed description
TRIAL DESIGN:
A prospective, single-masked, randomized, split-mouth, longitudinal clinical trial.
OUTCOME:
- The primary outcome was the number of experimental sites (PPD >4mm and <10mm) becoming closed pockets (PPD ≤ 4mm) at 6 weeks (T1) and 3 months (T2) after initial therapy.
- Secondary outcomes were the variations in PPD, REC (Clinical Gingival Recession), CAL (Clinical Attachment Level), BOP (Bleeding On Probing) and PI (Plaque Index) at the experimental sites and treatment time.
A 10% difference in the primary outcome between the two protocols was set as the threshold to define inferiority/non-inferiority of the Test treatment.
STUDY POPULATION:
thirty-two (32) adults, aged 18-75 years, will be entered into study (randomized).
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 CRITERIA:
- 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).
- Diagnosis of Stage III-IV periodontitis;17
- At least 6 sites per quadrant with Pocket Probing Depth (PPD) ≥ 3mm;
- At least 5 teeth per quadrant;
- Availability for the 3-month duration of the study for an assigned subject.
- Being tested
- Airflow, Perioflow and Erythritol powder and ultrasonic debridement, Ultrasonic debridement and curettes
- Keywords
- Periodontitis, Biofilm, Air-polishing, SRP, Ultrasonic
- Medical subject headings
- Aggressive Periodontitis, Periodontal Diseases, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Airflow, Perioflow and Erythritol powder and ultrasonic debridementDevice
Airflow and Perioflow combined with Erythritol powder will be used as an adjunct therapy
Ultrasonic debridement and curettesDevice
traditional Scaling and Root Planing with curettes and ultrasonic scaler
| Study group | Role | What they receive |
|---|---|---|
| Guided Biofilm Therapy | Experimental | Airflow with erythritol powder to remove supra and sub gingival biofilm and plaque, perioflow with erythritol powder at deep pathological pockets (PPD > 4mm) and ultrasonic debridement with an ultrasonic scaler for remove supra and sub gingival calculus. Receives: Device: Airflow, Perioflow and Erythritol powder and ultrasonic debridement |
| Scaling and Root Planning - Ultrasonic Debridement | Active comparator | Ultrasonic debridement with an ultrasonic scaler for remove supra and sub gingival calculus, manual debridement with curettes at deep pathological pockets (PPD > 4mm) and rubber cup with polishing to remove supra gingival biofilm and plaque. Receives: Device: Ultrasonic debridement and curettes |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of experimental sites (PPD > 4mm and <10mm) becoming closed pockets (PPD ≤ 4mm).
A 10% difference in the primary outcome between the two protocols was set as the threshold to define inferiority/non-inferiority of the Test treatment.
Measured: 3 months after initial therapy.
Secondary outcomes (5)
Change in PPD (periodontal depth)
Change in mean PD value for each patient measured (from the gingival margin to the bottom of the pocket). Baseline values will be compared to the values recorded in the follow-up visits.
Measured: 3 months after initial therapy.
Change in REC (Clinical Gingival Recession)
Change in mean of REC value for each patient should be calculated. Baseline values will be compared to the values recorded in the follow-up visits.
Measured: 3 months after initial therapy.
Change in CAL (Clinical Attachment Level)
Change in mean of CAL value for each patient should be calculated. Baseline values will be compared to the values recorded in the follow-up visits.
Measured: 3 months after initial therapy.
Change in BOP (Bleeding on Probing)
Change in percentage of sites positive to bleeding on probing. Baseline values will be compared to the values recorded in the follow-up visits.
Measured: 3 months after initial therapy.
Change in PI (Plaque Index)
Change in percentage of site with plaque. Baseline values will be compared to the values recorded in the follow-up visits.
Measured: 3 months after initial therapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2021
- Study start22 Nov 2016
- Primary completion4 Sep 2018
- Study completion4 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontitis, AggressiveStudies 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
- Split Mouth, RCT
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
- Sponsor type
- University, hospital or other
- 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
- NCT05112471
- Sponsor's protocol ID
- ERISRP
- Acronym
- ERISRP
- Status last verified
- Nov 2021
- First submitted
- 21 Oct 2021
- Last updated
- 8 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Combined Air-abrasive+Ultrasonic (Guided Biofilm Therapy GBT) vs. Standard Root Debridement (Scaling and Root Planing+ Ultrasonic SRP+US) in the Treatment of Severe Generalized Periodontitis: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05112471
- Acronym / sponsor ID
- ERISRP / ERISRP
- Keywords
- Periodontitis, Biofilm, Air-polishing, SRP, Ultrasonic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaUniversity, hospital or other
- Study start
- 22 Nov 2016 (actual)
- Primary completion
- 4 Sep 2018 (actual)
- Study completion
- 4 Apr 2020 (actual)
- First posted
- 8 Nov 2021 (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 aim of this randomized, controlled, split-mouth study was to compare the efficacy of full-mouth air-polishing followed by ultrasonic debridement (GBT) versus traditional Scaling and Root Planing (SRP), in terms of pocket closure in patients with stage III-IV periodontitis.
To test this hypothesis, the mouth of each patients, upon initial evaluation, were divided in 2 parts:
- The control group undergoing a standard procedure: ultrasonic debridement with an ultrasonic scaler for remove supra and sub gingival calculus, manual debridement with curettes at deep pathological pockets (PPD > 4mm) and rubber cup with polishing to remove supra gingival biofilm and plaque.
- The study group undergoing the innovative air polishing procedure: airflow with erythritol powder to remove supra and sub gingival biofilm and plaque, perioflow at deep pathological pockets (PPD > 4mm) and ultrasonic debridement with an ultrasonic scaler for remove supra and sub gingival calculus.
The prevalence of residual pockets will be evaluated at 6 weeks and 3 months after the initial therapy and compared between the two groups.
Detailed description
TRIAL DESIGN:
A prospective, single-masked, randomized, split-mouth, longitudinal clinical trial.
OUTCOME:
- The primary outcome was the number of experimental sites (PPD >4mm and <10mm) becoming closed pockets (PPD ≤ 4mm) at 6 weeks (T1) and 3 months (T2) after initial therapy.
- Secondary outcomes were the variations in PPD, REC (Clinical Gingival Recession), CAL (Clinical Attachment Level), BOP (Bleeding On Probing) and PI (Plaque Index) at the experimental sites and treatment time.
A 10% difference in the primary outcome between the two protocols was set as the threshold to define inferiority/non-inferiority of the Test treatment.
STUDY POPULATION:
thirty-two (32) adults, aged 18-75 years, will be entered into study (randomized).
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 CRITERIA:
- 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).
- Diagnosis of Stage III-IV periodontitis;17
- At least 6 sites per quadrant with Pocket Probing Depth (PPD) ≥ 3mm;
- At least 5 teeth per quadrant;
- 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
- Split Mouth, RCT
| Arm | Type | Receives |
|---|---|---|
| Guided Biofilm Therapy | Experimental | Device: Airflow, Perioflow and Erythritol powder and ultrasonic debridementAirflow with erythritol powder to remove supra and sub gingival biofilm and plaque, perioflow with erythritol powder at deep pathological pockets (PPD > 4mm) and ultrasonic debridement with an ultrasonic scaler for remove supra and sub gingival calculus. |
| Scaling and Root Planning - Ultrasonic Debridement | Active comparator | Device: Ultrasonic debridement and curettesUltrasonic debridement with an ultrasonic scaler for remove supra and sub gingival calculus, manual debridement with curettes at deep pathological pockets (PPD > 4mm) and rubber cup with polishing to remove supra gingival biofilm and plaque. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Signed Informed Consent Form.
- Male and female subjects, aged 18-75 years, with diagnosis of severe generalized periodontitis.
- 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).
- Diagnosis of Stage III-IV periodontitis;
- At least 6 sites per quadrant with Pocket Probing Depth (PPD) ≥ 3mm;
Key exclusion criteria (7 listed)
- Severe Smoking more than 10 cigarettes per day
- Pregnancy or nursing.
- Radiotherapy or Chemotherapy.
- BPCO (chronic obstructive pulmonary disease), asma.
- Systemic long-term corticosteroid 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 |
|---|---|---|
| Airflow, Perioflow and Erythritol powder and ultrasonic debridementAirflow and Perioflow combined with Erythritol powder will be used as an adjunct therapy | Device | Guided Biofilm Therapy |
| Ultrasonic debridement and curettestraditional Scaling and Root Planing with curettes and ultrasonic scaler | Device | Scaling and Root Planning - Ultrasonic Debridement |
Primary outcome
The number of experimental sites (PPD > 4mm and <10mm) becoming closed pockets (PPD ≤ 4mm).
Time frame: 3 months after initial therapy.
A 10% difference in the primary outcome between the two protocols was set as the threshold to define inferiority/non-inferiority of the Test treatment.
5 secondary outcomes
Change in PPD (periodontal depth)
Time frame: 3 months after initial therapy.
Change in REC (Clinical Gingival Recession)
Time frame: 3 months after initial therapy.
Change in CAL (Clinical Attachment Level)
Time frame: 3 months after initial therapy.
Change in BOP (Bleeding on Probing)
Time frame: 3 months after initial therapy.
Change in PI (Plaque Index)
Time frame: 3 months after initial therapy.
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 8 Nov 2021.
- 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 Airflow, Perioflow and Erythritol powder and ultrasonic debridement and Ultrasonic debridement and curettes in people with Periodontitis, Aggressive and Periodontal Diseases, 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 7 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: finished, as of the sponsor's last update on 8 Nov 2021. 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?
The number of experimental sites (PPD > 4mm and <10mm) becoming closed pockets (PPD ≤ 4mm). (time frame: 3 months after initial therapy.). 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 8 Nov 2021.