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Efficacy of Sub-gingival Air-polishing With Erythritol in the Treatment of Periodontitis (GBT2017)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04264624
Recruitment Status : Completed
First Posted : February 11, 2020
Last Update Posted : February 18, 2020
Sponsor:
Collaborator:
Università degli Studi di Ferrara
Information provided by (Responsible Party):
Magda Mensi, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Brief 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. 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:

  1. 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
  2. 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.


Condition or disease Intervention/treatment Phase
Periodontitis, Adult Periodontitis, Aggressive Device: Perioflow and Erythritol powder and ultrasonic debridement Device: Airflow and Erythritol powder and ultrasonic debridement Not Applicable

Detailed Description:

OUTCOME

  1. 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".
  2. 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.
  3. 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel-Arm, Examiner-Blinded, RCT
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Efficacy of Sub-gingival Air-polishing With Erythritol in the Treatment of Periodontitis
Actual Study Start Date : February 28, 2018
Actual Primary Completion Date : October 5, 2019
Actual Study Completion Date : December 10, 2019

Arm Intervention/treatment
Experimental: Guided Biofilm Therapy with Perioflow
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.
Device: Perioflow and Erythritol powder and ultrasonic debridement
Airflow and Perioflow combined with Erythritol powder will be used as an adjunct therapy

Device: Airflow and Erythritol powder and ultrasonic debridement
Airflow combined with Erythritol powder will be used as an adjunct therapy

Active Comparator: Guided Biofilm Therapy without Perioflow
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.
Device: Airflow and Erythritol powder and ultrasonic debridement
Airflow combined with Erythritol powder will be used as an adjunct therapy




Primary Outcome Measures :
  1. 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".



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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).
  • 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.

Exclusion Criteria:

  • 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, ...).
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04264624


Locations
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Italy
Magda Mensi
Brescia, Lombardia, Italy, 25124
Sponsors and Collaborators
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Università degli Studi di Ferrara
Investigators
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Principal Investigator: Magda Mensi ASST Spedali Civili di Brescia
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Responsible Party: Magda Mensi, Principal Investigator, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
ClinicalTrials.gov Identifier: NCT04264624    
Other Study ID Numbers: GBT2017
First Posted: February 11, 2020    Key Record Dates
Last Update Posted: February 18, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Magda Mensi, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia:
Guided Biofilm Therapy
Periodontitis
Erythritol
Additional relevant MeSH terms:
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Periodontitis
Chronic Periodontitis
Aggressive Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Erythritol
Vasodilator Agents