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

NCT ID: NCT05112471

Last Updated: 2021-11-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-22
• Study Completion Date: 2020-04-04

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. 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. 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:

1. 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.

2. 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.

Conditions

Periodontitis, Aggressive; Periodontal Diseases; Periodontitis

Keywords

Periodontitis; Biofilm; Air-polishing; SRP; Ultrasonic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Airflow, Perioflow and Erythritol powder and ultrasonic debridement

Intervention Type: DEVICE

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

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.

Group Type: ACTIVE_COMPARATOR

Ultrasonic debridement and curettes

Intervention Type: DEVICE

traditional Scaling and Root Planing with curettes and ultrasonic scaler

Interventions

Airflow, Perioflow and Erythritol powder and ultrasonic debridement

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

Intervention Type: DEVICE

Ultrasonic debridement and curettes

traditional Scaling and Root Planing with curettes and ultrasonic scaler

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

OTHER

Sponsor Role: lead

Responsible Party

Magda Mensi

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Magda Mensi

Role: PRINCIPAL_INVESTIGATOR

ASST Spedali Civili di Brescia

Locations

Magda Mensi

Brescia, Lombardy, Italy

Countries

Italy

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

ERISRP

Identifier Type: -

Identifier Source: org_study_id