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

NCT04264624 | Completed DMC

• 1 other identifier: GBT2017
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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. 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. 2.The study group, undergoing the same procedure but with the additional use of a sub-gingival nozzle at deep pathological pockets.

Conditions

Periodontitis, Adult; Periodontitis, Aggressive

Keywords

Guided Biofilm Therapy; Periodontitis; Erythritol

Outcome Measures

Primary Outcomes (1)

• 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".

  through study completion, an average of 1 year

Study Arms (2)

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.

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.

Device: Airflow and Erythritol powder and ultrasonic debridement

Interventions

Perioflow and Erythritol powder and ultrasonic debridement DEVICE

Airflow and Perioflow combined with Erythritol powder will be used as an adjunct therapy

Guided Biofilm Therapy with Perioflow

Airflow and Erythritol powder and ultrasonic debridement DEVICE

Airflow combined with Erythritol powder will be used as an adjunct therapy

Guided Biofilm Therapy with Perioflow; Guided Biofilm Therapy without Perioflow

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia: lead
• Università degli Studi di Ferrara: collaborator

Study Sites (1)

Magda Mensi

Brescia, Lombardy, 25124, Italy

Location

Related Publications (2)

• 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.

  PMID: 36538094 DERIVED

• Mensi 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.

  PMID: 33404760 DERIVED

MeSH Terms

Conditions

Chronic Periodontitis; Aggressive Periodontitis; Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Magda Mensi

  ASST Spedali Civili di Brescia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Parallel-Arm, Examiner-Blinded, RCT

Study Record Dates

• First Submitted: June 24, 2019
• First Posted: February 11, 2020
• Study Start: February 28, 2018
• Primary Completion: October 5, 2019
• Study Completion: December 10, 2019
• Last Updated: February 18, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)