- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07344805
Clinical Effects and Metagenomic Analysis of Using an Air Polishing Device With Erythritol Powder Compared to Scaling and Root Planing in Periodontal Maintenance Therapy.
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Valencia
-
Alfara del Patriarca, Valencia, Spain, 46115
- Universidad CEU Cardenal Herrera
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients who have received basic periodontal treatment between 3-6 months before the study.
Exclusion Criteria:
- Pregnant or breastfeeding patients.
- Use of systemic antibiotics within 6 months prior to the study.
- Patients who smoke more than 10 cigarettes/day.
- Uncontrolled diabetic patients.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Periodontal maintenance with ultrasonic + scaling and root planning
|
Periodontal maintenance with ultrasonic scaler and manual curettes in periodontal patients.
|
|
Experimental: Periodontal maintenance with erythritol air polishing
|
Periodontal Maintenance with Erythritol Air Polisher in periodontal patients.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Improvement of clinical periodontal parameter: clinical attachment level
Time Frame: six months
|
Measurement of clinical attachment level in milimeters
|
six months
|
|
Improvement of clinical periodontal parameter: probing depth
Time Frame: six months
|
Measurement of probing depth in milimeters
|
six months
|
|
Improvement of clinical periodontal parameter: bleeding index
Time Frame: six months
|
Measurement of bleeding index in percentage.
|
six months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in periodontal microbiome
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. |
Six months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient discomfort
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)).
|
Six months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Isidoro Cortell-Ballester, DDS, MD, PhD, Cardenal Herrera University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CEU-Martinez-Gonzalez-Cortell
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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