Novel Protocol for Supportive Periodontal Therapy

NCT05799261 | Completed

• 1 other identifier: 2019-00046
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Supportive periodontal therapy (SPT) succeeds the active phase of periodontal therapy. SPT includes repeated supra- and subgingival scaling and root planing (SRP) at all sites with bleeding on probing and pocket depths ≥ 4-5 mm. Despite the fact that this treatment approach has been proven to be extremely successful, on a long-time basis, it is associated with substantial hard tissue loss (i.e. root cementum and dentin) that may lead to an increase in hypersensitivity, weakening of the tooth and even endodontic complications. Therefore, a novel treatment concept (Guided Biofilm Management or GBM) consisting of removal of all soft supra- and subgingival bacterial deposits by means of an erythritol powder air-polishing, followed by the local, precise removal of supra and subgingival hard deposits (e.g. calculus) and subsequent use of another sub- and supragingival erythritol powder air-polishing, has been introduced. Here, the investigators will compare this novel concept (GBM) with the conventional care during SPT using hand curettes.

Conditions

Periodontitis

Keywords

Guided biofilm management; Supportive periodontal therapy

Outcome Measures

Primary Outcomes (1)

• Change in bleeding on probing

  This is a categorical variable defined as the percentage of bleeding sites out of the total number of sites. Hereby, all gingival sulci and pockets will be measured with a periodontal probe and bleeding sites will be recorded. The maximum is 100% and the minimum 0%. Higher values represent a worse outcome.

  Over the study period of 3 years at every recall (i.e. every 6 months)

Secondary Outcomes (4)

• Change in probing pocket depth

  Over the study duration of 3 years at every recall (i.e. every 6 months)

• Clinical attachment level

  At the beginning of the study, after 1 year and after 3 years

• Patient comfort

  Over the study duration after 1, 2, and 3 years

• Time effectiveness

  Over the study duration of 3 years at every recall (i.e. every 6-months)

Study Arms (2)

Control (standard protocol)

ACTIVE COMPARATOR

The control group will be treated according to standard protocols of the Department of Periodontology of the university of Bern and receive conventional scaling and root planing. Supra- and subgingival hard and soft tissue deposits are being removed by means of hand instruments and ultra-sonic scalers followed by rubber cup polishing. All patients will have 2 visits per year. At each visit outcome measures will be assessed by masked dentists.

Procedure: Control (standard protocol)

Test (Guided Biofilm management)

EXPERIMENTAL

The test group will be treated according to a novel treatment concept (Guided biofilm management, GBM): 1. Staining of all tooth surfaces to detect soft and hard deposits. 2. Removal of supra- and subgingival hard and soft bacterial deposits by means of an erythritol powder air-polishing. 3. If present, the supra- and subgingival hard deposits (e.g. calculus) will be removed by means of a slim ultrasonic tip (Piezon PS, EMS, Nyon Switzerland) without any additional use of hand instruments. 4. Another sub- and supragingival application of erythritol powder air-polishing without any rubber cup polishing. All patients will have 2 visits per year. At each visit outcome measures will be assessed by masked dentists.

Procedure: Test (Guided Biofilm management)

Interventions

Control (standard protocol) PROCEDURE

The control group will be treated according to standard protocols of the Department of Periodontology of the university of Bern and receive conventional scaling and root planing. Supra- and subgingival hard and soft tissue deposits are being removed by means of hand instruments and ultra-sonic scalers followed by rubber cup polishing. All patients will have 2 visits per year. At each visit outcome measures will be assessed by masked dentists.

Control (standard protocol)

Test (Guided Biofilm management) PROCEDURE

The test group will be treated according to a novel treatment concept (Guided biofilm management, GBM): 1. Staining of all tooth surfaces to detect soft and hard deposits. 2. Removal of supra- and subgingival hard and soft bacterial deposits by means of an erythritol powder air-polishing. 3. If present, the supra- and subgingival hard deposits (e.g. calculus) will be removed by means of a slim ultrasonic tip (Piezon PS, EMS, Nyon Switzerland) without any additional use of hand instruments. 4. Another sub- and supragingival application of erythritol powder air-polishing without any rubber cup polishing. All patients will have 2 visits per year. At each visit outcome measures will be assessed by masked dentists.

Test (Guided Biofilm management)

Eligibility Criteria

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

You may qualify if:

• Written informed consent
• Patient adherent to supportive periodontal therapy
• With \< 6 mm probing pocket depth (PPD)

You may not qualify if:

• Clinically significant concomitant diseases
• Enrolment in a clinical trial

Sponsors & Collaborators

• University of Bern: lead

Study Sites (1)

Department of Periodontology, University of Bern

Bern, 3010, Switzerland

Location

Related Publications (2)

• Hagi TT, Hofmanner P, Eick S, Donnet M, Salvi GE, Sculean A, Ramseier CA. The effects of erythritol air-polishing powder on microbiologic and clinical outcomes during supportive periodontal therapy: Six-month results of a randomized controlled clinical trial. Quintessence Int. 2015 Jan;46(1):31-41. doi: 10.3290/j.qi.a32817.

  PMID: 25262675 BACKGROUND

• Hagi TT, Klemensberger S, Bereiter R, Nietzsche S, Cosgarea R, Flury S, Lussi A, Sculean A, Eick S. A Biofilm Pocket Model to Evaluate Different Non-Surgical Periodontal Treatment Modalities in Terms of Biofilm Removal and Reformation, Surface Alterations and Attachment of Periodontal Ligament Fibroblasts. PLoS One. 2015 Jun 29;10(6):e0131056. doi: 10.1371/journal.pone.0131056. eCollection 2015.

  PMID: 26121365 RESULT

Related Links

• Standardized human dentin specimens were colonized by multi-species biofilms for 3.5 days and subsequently treated as follows: a) hand-instrumentation b) ultrasonication c) air-polishing using erythritol and d) erythritol combined with chlor
• 40 chronic periodontitis patients previously enrolled in SPT were randomly assigned into two groups for the treatment with subgingival EPAP or repeated scaling and root planing (SRP).

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Anton Sculean, Prof.

  University of Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients in supportive periodontal therapy will be treated according to standard protocols of the Department of Periodontology. The test group patient will undergo treatment by the concept of Guided Biofilm Management consisting of removal of soft supra- and subgingival bacterial deposits by means of erythritol powder air-polishing, followed by the local precise removal of hard deposits and a subsequent use of another sub- and supragingival erythritol powder air-polishing. The study duration will be 3 years.

Study Record Dates

• First Submitted: December 23, 2022
• First Posted: April 5, 2023
• Study Start: January 1, 2022
• Primary Completion: June 19, 2025
• Study Completion: June 19, 2025
• Last Updated: June 22, 2025

Record last verified: 2025-06

Locations

CH (1)