PeriodontitisGBMNCT05799261
Novel Protocol for Supportive Periodontal Therapy
A study testing Test (Guided Biofilm management) in people with Periodontitis, run by University of Bern at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- What is being tested?
- Test (Guided Biofilm management)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jan 2022to 19 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Written informed consent
- Patient adherent to supportive periodontal therapy
- With < 6 mm probing pocket depth (PPD)
Who cannot join
- Clinically significant concomitant diseases
- Enrolment in a clinical trial
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Periodontology, University of Bern
Bern, 3010
About this study
Official title: Clinical Evaluation of a Novel Protocol (Guided Biofilm Management) for Supportive Periodontal Therapy: a Long-term Randomized Controlled Clinical Study
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.
Read the detailed description
There is solid scientific evidence demonstrating that the clinical results obtained following active periodontal therapy can be maintained on a long-term basis provided that regular supportive periodontal therapy (SPT) is rendered. On a routine basis, 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. Since patients enrolled in SPT have usually probing pocket depths (PPD) < 6 mm and limited supra- and subgingival deposits, the question arises whether SRP by means of hand and ultrasonic instruments may be needed at all sites with a PPD > 4 mm with BOP (+) that do not exhibit hard bacterial deposits (e.g. supra and subgingival calculus). It has been repeatedly shown that bacterial deposits can be removed from the root surfaces by mere polishing without any SRP, thus leading to comparable clinical outcomes than following the use of conventional SRP by means of hand instruments (e.g. metal curettes). The removal of "diseased" root cementum is therefore not necessary to accomplish clinical success. Results from a recent "in-vitro" study using a novel "subgingival pocket model" have shown that compared to hand instrumentation, the application of an air-polishing with erythritol prevents substance-loss and results in a smooth surface with nearly no residual biofilm that promotes the reattachment of PDL fibroblasts. These findings are in line with the results of a randomized controlled clinical study which has shown that biofilm removal by means of an erythritol powder based air-polishing yielded similar outcomes to those obtained with conventional SRP. Moreover, the use of the erythritol powder air-polishing yielded statistically and clinically better patient acceptance.
Based on these results 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.
The authors hypothesize that this approach may enable to render a more personalized and precise treatment for patients enrolled in SPT, thus leading to less hard tissue loss and better patient acceptance.
- Conditions
- Periodontitis
- Being tested
- Control (standard protocol), Test (Guided Biofilm management)
- Keywords
- Guided biofilm management, Supportive periodontal therapy
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control (standard protocol)Procedure or surgery
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.
Test (Guided Biofilm management)Procedure or surgery
The test group will be treated according to a novel treatment concept (Guided biofilm management, GBM):
- Staining of all tooth surfaces to detect soft and hard deposits.
- Removal of supra- and subgingival hard and soft bacterial deposits by means of an erythritol powder air-polishing.
- 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.
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Test (Guided Biofilm management) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Over the study period of 3 years at every recall (i.e. every 6 months)
Secondary outcomes (4)
Change in probing pocket depth
Pocket depths will be measured by means of a periodontal probe. The minimal clinically measured pockets are 1 mm and the maximal value for pocket depths allowed in this study is 5 mm. Higher pocket depth values represent worse results. With respect to the reduction in probing depth it is the other way round. A higher value of 3 mm (maximal reduction value) represent better outcomes and a smaller reduction or none (0 mm).
Measured: Over the study duration of 3 years at every recall (i.e. every 6 months)
Clinical attachment level
Gingival recessions and pockets depths both measured with millimeter-indicating periodontal probes will be measured and added to the clinical attachment loss/level. Minimal values are 0 mm or even 1 to 2 mm below zero. While maximal values are around 3 mm.
Measured: At the beginning of the study, after 1 year and after 3 years
Patient comfort
Assessed by a Visual Analogue Scale (VAS). VAS is a 100 mm scale with 0 being the worst imaginable satisfaction and 100 mm perfect satisfaction with the treatment. In terms of pain it is the opposite with 0 representing no pain and 100 mm the worst imaginable pain sensation.
Measured: Over the study duration after 1, 2, and 3 years
Time effectiveness
The time that is needed to do a thorough cleaning according to the respective protocol the patient was allocated to. For this purpose the dental hygienists are recording the time in minutes. Minimal amount of time is 30 minutes and maximal time is 60 minutes.
Measured: Over the study duration of 3 years at every recall (i.e. every 6-months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2023
- Study start1 Jan 2022
- Primary completion19 Jun 2025
- Study completion19 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anton Sculean, Prof., Principal investigator, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05799261
- Sponsor's protocol ID
- 2019-00046
- Other IDs
- 2019
- Acronym
- GBM
- Status last verified
- Jun 2025
- First submitted
- 23 Dec 2022
- Last updated
- 22 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 25262675Hagi 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.
PubMed 26121365Stahli A, Ferrari J, Schatzmann AS, Weigel LD, Roccuzzo A, Imber JC, Duong HY, Eick S, Lang NP, Salvi GE, Sculean A. Clinical evaluation of a novel protocol for supportive periodontal care: A randomized controlled clinical trial. J Periodontol. 2024 Nov;95(11):1025-1034. doi: 10.1002/JPER.23-0527. Epub 2024 Jan 31.
PubMed 38291892
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of a Novel Protocol (Guided Biofilm Management) for Supportive Periodontal Therapy: a Long-term Randomized Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT05799261
- Acronym / sponsor ID
- GBM / 2019-00046
- Conditions
- Periodontitis
- Keywords
- Guided biofilm management, Supportive periodontal therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of BernUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 19 Jun 2025 (actual)
- Study completion
- 19 Jun 2025 (actual)
- First posted
- 5 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
There is solid scientific evidence demonstrating that the clinical results obtained following active periodontal therapy can be maintained on a long-term basis provided that regular supportive periodontal therapy (SPT) is rendered. On a routine basis, 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. Since patients enrolled in SPT have usually probing pocket depths (PPD) < 6 mm and limited supra- and subgingival deposits, the question arises whether SRP by means of hand and ultrasonic instruments may be needed at all sites with a PPD > 4 mm with BOP (+) that do not exhibit hard bacterial deposits (e.g. supra and subgingival calculus). It has been repeatedly shown that bacterial deposits can be removed from the root surfaces by mere polishing without any SRP, thus leading to comparable clinical outcomes than following the use of conventional SRP by means of hand instruments (e.g. metal curettes). The removal of "diseased" root cementum is therefore not necessary to accomplish clinical success. Results from a recent "in-vitro" study using a novel "subgingival pocket model" have shown that compared to hand instrumentation, the application of an air-polishing with erythritol prevents substance-loss and results in a smooth surface with nearly no residual biofilm that promotes the reattachment of PDL fibroblasts. These findings are in line with the results of a randomized controlled clinical study which has shown that biofilm removal by means of an erythritol powder based air-polishing yielded similar outcomes to those obtained with conventional SRP. Moreover, the use of the erythritol powder air-polishing yielded statistically and clinically better patient acceptance.
Based on these results 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.
The authors hypothesize that this approach may enable to render a more personalized and precise treatment for patients enrolled in SPT, thus leading to less hard tissue loss and better patient acceptance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control (standard protocol) | Active comparator | Procedure: Control (standard protocol)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. |
| Test (Guided Biofilm management) | Experimental | Procedure: Test (Guided Biofilm management)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Written informed consent
- Patient adherent to supportive periodontal therapy
- With < 6 mm probing pocket depth (PPD)
Key exclusion criteria (2 listed)
- Clinically significant concomitant diseases
- Enrolment in a clinical trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control (standard protocol)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 or surgery | Control (standard protocol) |
| Test (Guided Biofilm management)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 or surgery | Test (Guided Biofilm management) |
Primary outcome
Change in bleeding on probing
Time frame: Over the study period of 3 years at every recall (i.e. every 6 months)
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.
4 secondary outcomes
Change in probing pocket depth
Time frame: Over the study duration of 3 years at every recall (i.e. every 6 months)
Clinical attachment level
Time frame: At the beginning of the study, after 1 year and after 3 years
Patient comfort
Time frame: Over the study duration after 1, 2, and 3 years
Time effectiveness
Time frame: Over the study duration of 3 years at every recall (i.e. every 6-months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2025.
- Background: PubMed 25262675Hagi 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.
- Results publication: PubMed 26121365Hagi 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.
- Derived from this study: PubMed 38291892Stahli A, Ferrari J, Schatzmann AS, Weigel LD, Roccuzzo A, Imber JC, Duong HY, Eick S, Lang NP, Salvi GE, Sculean A. Clinical evaluation of a novel protocol for supportive periodontal care: A randomized controlled clinical trial. J Periodontol. 2024 Nov;95(11):1025-1034. doi: 10.1002/JPER.23-0527. Epub 2024 Jan 31.
- 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 chlorLink provided by the sponsor.
- 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).Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anton Sculean, Prof. principal investigator
University of Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test (Guided Biofilm management) in people with Periodontitis, run by University of Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in bleeding on probing (time frame: Over the study period of 3 years at every recall (i.e. every 6 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05799261, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2025.