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Completed

NCT Number: NCT05112471

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

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.

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Key information

Conditions

Periodontitis, Aggressive Aggressive Periodontitis Mouth Diseases Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Magda Mensi

Brescia, Lombardy, 25123, Italy

About this study

TRIAL DESIGN:

A prospective, single-masked, randomized, split-mouth, longitudinal clinical trial.

OUTCOME:

  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Airflow, Perioflow and Erythritol powder and ultrasonic debridement

Device

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

Ultrasonic debridement and curettes

Device

traditional Scaling and Root Planing with curettes and ultrasonic scaler

Primary outcomes

  1. The number of experimental sites (PPD > 4mm and <10mm) becoming closed pockets (PPD ≤ 4mm).

    Time frame: 3 months after initial therapy.

    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.

Secondary outcomes

  1. Change in PPD (periodontal depth)

    Time frame: 3 months after initial therapy.

    Change in mean PD value for each patient measured (from the gingival margin to the bottom of the pocket). Baseline values will be compared to the values recorded in the follow-up visits.

  2. Change in REC (Clinical Gingival Recession)

    Time frame: 3 months after initial therapy.

    Change in mean of REC value for each patient should be calculated. Baseline values will be compared to the values recorded in the follow-up visits.

  3. Change in CAL (Clinical Attachment Level)

    Time frame: 3 months after initial therapy.

    Change in mean of CAL value for each patient should be calculated. Baseline values will be compared to the values recorded in the follow-up visits.

  4. Change in BOP (Bleeding on Probing)

    Time frame: 3 months after initial therapy.

    Change in percentage of sites positive to bleeding on probing. Baseline values will be compared to the values recorded in the follow-up visits.

  5. Change in PI (Plaque Index)

    Time frame: 3 months after initial therapy.

    Change in percentage of site with plaque. Baseline values will be compared to the values recorded in the follow-up visits.

Sponsors and collaborators

Lead sponsor

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Other

Registry information

Official study 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

Acronym: ERISRP

Important dates

Study start
2016
Primary completion
2018
Study completion
2020
First posted
Nov 8, 2021
Registry last updated
Nov 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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