Efficacy of GBT vs SRP+US, in the Treatment of Severe Generalized Periodontitis.

NCT05112471 | Completed DMC

• 1 other identifier: ERISRP
• Study Type: interventional
• Target: 32
• 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 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:

1. 1.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.
2. 2.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.

Conditions

Periodontitis, Aggressive; Periodontal Diseases; Periodontitis

Keywords

Periodontitis; Biofilm; Air-polishing; SRP; Ultrasonic

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months after initial therapy.

Secondary Outcomes (5)

• Change in PPD (periodontal depth)

  3 months after initial therapy.

• Change in REC (Clinical Gingival Recession)

  3 months after initial therapy.

• Change in CAL (Clinical Attachment Level)

  3 months after initial therapy.

• Change in BOP (Bleeding on Probing)

  3 months after initial therapy.

• Change in PI (Plaque Index)

  3 months after initial therapy.

Study Arms (2)

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.

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.

Device: Ultrasonic debridement and curettes

Interventions

Airflow, 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

Ultrasonic debridement and curettes DEVICE

traditional Scaling and Root Planing with curettes and ultrasonic scaler

Scaling and Root Planning - Ultrasonic Debridement

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, 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia: lead

Study Sites (1)

Magda Mensi

Brescia, Lombardy, 25123, Italy

Location

MeSH Terms

Conditions

Aggressive Periodontitis; Periodontal Diseases; Periodontitis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

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: Split Mouth, RCT

Study Record Dates

• First Submitted: October 21, 2021
• First Posted: November 8, 2021
• Study Start: November 22, 2016
• Primary Completion: September 4, 2018
• Study Completion: April 4, 2020
• Last Updated: November 8, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)