Clinical trial NCT05799261: Novel Protocol for Supportive Periodontal Therapy
Official title: Clinical Evaluation of a Novel Protocol (Guided Biofilm Management) for Supportive Periodontal Therapy: a Long-term Randomized Controlled Clinical Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Periodontitis
Keywords: Guided biofilm management
Supportive periodontal therapy
Lead sponsor: University of Bern
Sponsor class: OTHER
First posted: 2023-04-05
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Clinically significant concomitant diseases
* Enrolment in a clinical trial

Primary outcomes:
measure: Change in bleeding on probing
timeFrame: Over the study period of 3 years at every recall (i.e. every 6 months)
Secondary outcomes:
measure: Change in probing pocket depth
timeFrame: Over the study duration of 3 years at every recall (i.e. every 6 months)
measure: Clinical attachment level
timeFrame: At the beginning of the study, after 1 year and after 3 years
measure: Patient comfort
timeFrame: Over the study duration after 1, 2, and 3 years
measure: Time effectiveness
timeFrame: Over the study duration of 3 years at every recall (i.e. every 6-months)
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Department of Periodontology, University of Bern
Study officials:
affiliation: University of Bern
name: Anton Sculean, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.