Clinical trial NCT05112471: Efficacy of GBT vs SRP+US, in the Treatment of Severe Generalized Periodontitis.
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontitis, Aggressive
Periodontal Diseases
Periodontitis
Keywords: Periodontitis
Biofilm
Air-polishing
SRP
Ultrasonic
Lead sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Sponsor class: OTHER
First posted: 2021-11-08
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Split Mouth, RCT
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: The number of experimental sites (PPD > 4mm and <10mm) becoming closed pockets (PPD ≤ 4mm).
timeFrame: 3 months after initial therapy.
Secondary outcomes:
measure: Change in PPD (periodontal depth)
timeFrame: 3 months after initial therapy.
measure: Change in REC (Clinical Gingival Recession)
timeFrame: 3 months after initial therapy.
measure: Change in CAL (Clinical Attachment Level)
timeFrame: 3 months after initial therapy.
measure: Change in BOP (Bleeding on Probing)
timeFrame: 3 months after initial therapy.
measure: Change in PI (Plaque Index)
timeFrame: 3 months after initial therapy.
Other outcomes:
Locations:
city: Brescia
country: Italy
facility: Magda Mensi
state: Lombardia
Study officials:
affiliation: ASST Spedali Civili di Brescia
name: Magda Mensi
role: PRINCIPAL_INVESTIGATOR
References: