An interventional study of Perioflow and Erythritol powder and ultrasonic debridement and Airflow and Erythritol powder and ultrasonic debridement in Periodontitis, Adult and Periodontitis, Aggressive, sponsored by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia. Completed at 1 site in Italy. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-18.
Sponsored by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia · Not applicable, Interventional, and Supportive care
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 hypothesis of the present randomized controlled trial was that the adjunctive use of a sub-gingival nozzle for air-polishing with erythritol powder in pockets with probing depth of 5-9mm and with bleeding (experimental sites) can bring clinical and microbiological advantages during the active therapy of periodontal disease, and reduce the number of residual pockets.
To test this hypothesis, the patients, upon initial evaluation, were divided in 2 study groups:
The healing of the experimental sites and the prevalence of residual pockets will be evaluated at 3 months after the initial therapy and compared between the two groups.
OUTCOME
STUDY POPULATION Forty (40) adults, aged 18-75 years, will be entered into study (randomized). It is expected that at least thirty-two (32) subjects will complete the study.
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 Characteristics
1,635 studies on the registry are indexed under Periodontitis; 327 are open to participants now.
This study's enrollment of 40 is below the median of 45 across 1,191 interventional studies indexed under Periodontitis.
Browse Periodontitis studies →Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia is the lead sponsor of 81 studies on the registry; 15 are open to participants now.
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Exclusion Criteria:
The entire mouth will be treated (supra-/subgingival) in a single session. If the patient has been identified to receive the adjunctive treatment, he/she will also receive subgingival biofilm removal with Perioflow combined with Erythritol powder at sites with PD≥ 5 mm, including the experimental sites, prior to subgingival biofilm removal with USD.
Device: Perioflow and Erythritol powder and ultrasonic debridement · Device: Airflow and Erythritol powder and ultrasonic debridement
The entire mouth will be treated (supra-/subgingival) in a single session. If the patient has been identified to receive the control treatment, all teeth present will receive the application of disclosing agent, full-mouth supragingival and intra-sulcular biofilm removal with Airflow at sites with PD up to 4 mm, full mouth supra gingival calculus removal with USD, and subgingival biofilm removal with USD at sites with PD\> 4 mm, including the experimental sites, as required.
Device: Airflow and Erythritol powder and ultrasonic debridement
Airflow and Perioflow combined with Erythritol powder will be used as an adjunct therapy
Airflow combined with Erythritol powder will be used as an adjunct therapy
Primary outcome measure:3 month and to the end of study ( 1 years)
Sites characterized by PD 5-9 mm and BoP+ will be therefore identified as "experimental sites".
Time frame: through study completion, an average of 1 year
Plan to share: No
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia