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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Periodontal maintenance with ultrasonic + scaling and root planning | Active Comparator |
| |
| Periodontal maintenance with erythritol air polishing | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AIRFLOW® Prophylaxis Master | Device | Periodontal Maintenance with Erythritol Air Polisher in periodontal patients. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of clinical periodontal parameter: clinical attachment level | Measurement of clinical attachment level in milimeters | six months |
| Improvement of clinical periodontal parameter: probing depth | Measurement of probing depth in milimeters | six months |
| Improvement of clinical periodontal parameter: bleeding index | Measurement of bleeding index in percentage. | six months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in periodontal microbiome | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient discomfort | Measurement of patient discomfort during the treatment by Visual Analogue Scale (VAS) Questionnaire (from no pain (score 0) to maximum pain imaginable (score 7)). | Six months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Isidoro Cortell-Ballester, DDS, MD, PhD | Cardenal Herrera University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad CEU Cardenal Herrera | Alfara del Patriarca | Valencia | 46115 | Spain |
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| Cavitron® ultrasonic scaler | Device | Periodontal maintenance with ultrasonic scaler and manual curettes in periodontal patients. |
|
| Six months |
| ID | Term |
|---|---|
| D010518 | Periodontitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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