Universidad CEU Cardenal Herrera
Alfara del Patriarca, Valencia, 46115, Spain
NCT Number: NCT07344805
Periodontitis is a chronic, multifactorial disease primarily driven by the accumulation of bacterial deposits. Treatment involves the mechanical removal of the biofilm, traditionally performed by scaling and root planing (SRP). However, SRP is time-consuming and can cause irreversible damage to both hard and soft tissues as well as postoperative sensitivity. Consequently, adjunctive or alternative air-polishing devices have been developed. The objective of this study is to compare the clinical and microbiological efficacy of an erythritol-powder air-polishing device versus SRP in periodontal maintenance therapy.To evaluate patient-reported pain and treatment time for erythritol air-polishing versus SRP. A randomized clinical trial was designed and participants were randomly assigned to one of two groups: Intervention: Perio-Flow® (air + erythritol powder) and PIEZON PS®. Control: Ultrasonic debridement followed by SRP with Gracey curettes.At baseline and at six months, probing depth, clinical attachment level, and bleeding on probing were recorded. Saliva samples were collected to detect the most prevalent periodontal pathogens. Patient discomfort during treatment was measured by a visual analog scale, and procedure duration was timed.
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Notify Me18 year–90 year
All sexes
Interventional
Not applicable
Alfara del Patriarca, Valencia, 46115, Spain
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Periodontal Maintenance with Erythritol Air Polisher in periodontal patients.
Periodontal maintenance with ultrasonic scaler and manual curettes in periodontal patients.
Time frame: six months
Measurement of clinical attachment level in milimeters
Time frame: six months
Measurement of probing depth in milimeters
Time frame: six months
Measurement of bleeding index in percentage.
Time frame: Six months
We will present the following analyses:
The overall and differential abundance of taxa will be analyzed using Kruskal Wallis non-parametric test. FDR Benjamini-Hochberg correction will be used to correct for multiple comparisons.
Differences in community structure between experimental and control groups will be tested using Permanova. Permdisp test will be used to identify location vs. dispersion effects .
The threshold for significance for all analyses will be set at p ≤ 0.05.
'BiodiversityR' version 2.11-1, 'PMCMR' version 4.3 and 'vegan' version 2.5-5 packages of the R software package version 36.6.0 (www.R-project.org) will be used.
Time frame: Six months
Measurement of patient discomfort during the treatment by Visual Analogue Scale (VAS) Questionnaire (from no pain (score 0) to maximum pain imaginable (score 7)).
Cardenal Herrera University
Other
Clinical Effects and Metagenomic Analysis of Using an Air Polishing Device With Erythritol Powder Compared to Scaling and Root Planing in Periodontal Maintenance Therapy: A Randomized Clinical Trial
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