- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05112471
Efficacy of GBT vs SRP+US, in the Treatment of Severe Generalized Periodontitis. (ERISRP)
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.
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.
Study Overview
Status
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Lombardia
-
Brescia, Lombardia, Italy, 25123
- Magda Mensi
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Guided Biofilm Therapy
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.
|
Airflow and Perioflow combined with Erythritol powder will be used as an adjunct therapy
|
Active Comparator: Scaling and Root Planning - Ultrasonic Debridement
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.
|
traditional Scaling and Root Planing with curettes and ultrasonic scaler
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
3 months after initial therapy.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in PPD (periodontal depth)
Time Frame: 3 months after initial therapy.
|
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.
|
3 months after initial therapy.
|
Change in REC (Clinical Gingival Recession)
Time Frame: 3 months after initial therapy.
|
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.
|
3 months after initial therapy.
|
Change in CAL (Clinical Attachment Level)
Time Frame: 3 months after initial therapy.
|
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.
|
3 months after initial therapy.
|
Change in BOP (Bleeding on Probing)
Time Frame: 3 months after initial therapy.
|
Change in percentage of sites positive to bleeding on probing.
Baseline values will be compared to the values recorded in the follow-up visits.
|
3 months after initial therapy.
|
Change in PI (Plaque Index)
Time Frame: 3 months after initial therapy.
|
Change in percentage of site with plaque.
Baseline values will be compared to the values recorded in the follow-up visits.
|
3 months after initial therapy.
|
Collaborators and Investigators
Investigators
- Principal Investigator: Magda Mensi, ASST Spedali Civili di Brescia
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ERISRP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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