Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-30 @ 1:13 AM
Study NCT ID:
NCT07344805
Status:
COMPLETED
Last Update Posted:
2026-01-15
First Post:
2025-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Effects and Metagenomic Analysis of Using an Air Polishing Device With Erythritol Powder Compared to Scaling and Root Planing in Periodontal Maintenance Therapy.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010518', 'term': 'Periodontitis'}], 'ancestors': [{'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-01-08', 'studyFirstSubmitDate': '2025-11-19', 'studyFirstSubmitQcDate': '2026-01-08', 'lastUpdatePostDateStruct': {'date': '2026-01-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Patient discomfort', 'timeFrame': 'Six months', 'description': 'Measurement of patient discomfort during the treatment by Visual Analogue Scale (VAS) Questionnaire (from no pain (score 0) to maximum pain imaginable (score 7)).'}], 'primaryOutcomes': [{'measure': 'Improvement of clinical periodontal parameter: clinical attachment level', 'timeFrame': 'six months', 'description': 'Measurement of clinical attachment level in milimeters'}, {'measure': 'Improvement of clinical periodontal parameter: probing depth', 'timeFrame': 'six months', 'description': 'Measurement of probing depth in milimeters'}, {'measure': 'Improvement of clinical periodontal parameter: bleeding index', 'timeFrame': 'six months', 'description': 'Measurement of bleeding index in percentage.'}], 'secondaryOutcomes': [{'measure': 'Changes in periodontal microbiome', 'timeFrame': 'Six months', 'description': "We will present the following analyses:\n\n* Overall and differential abundance\n* Comparative relative inter-group community structure differences\n\nThe 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.\n\nDifferences in community structure between experimental and control groups will be tested using Permanova. Permdisp test will be used to identify location vs. dispersion effects .\n\nThe threshold for significance for all analyses will be set at p ≤ 0.05.\n\n'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."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['periodontal maintenance', 'erythritol', 'powder air polishing'], 'conditions': ['Periodontitis']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who have received basic periodontal treatment between 3-6 months before the study.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding patients.\n* Use of systemic antibiotics within 6 months prior to the study.\n* Patients who smoke more than 10 cigarettes/day.\n* Uncontrolled diabetic patients.'}, 'identificationModule': {'nctId': 'NCT07344805', 'briefTitle': 'Clinical Effects and Metagenomic Analysis of Using an Air Polishing Device With Erythritol Powder Compared to Scaling and Root Planing in Periodontal Maintenance Therapy.', 'organization': {'class': 'OTHER', 'fullName': 'Cardenal Herrera University'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'CEU-Martinez-Gonzalez-Cortell'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Periodontal maintenance with ultrasonic + scaling and root planning', 'interventionNames': ['Device: Cavitron® ultrasonic scaler']}, {'type': 'EXPERIMENTAL', 'label': 'Periodontal maintenance with erythritol air polishing', 'interventionNames': ['Device: AIRFLOW® Prophylaxis Master']}], 'interventions': [{'name': 'AIRFLOW® Prophylaxis Master', 'type': 'DEVICE', 'description': 'Periodontal Maintenance with Erythritol Air Polisher in periodontal patients.', 'armGroupLabels': ['Periodontal maintenance with erythritol air polishing']}, {'name': 'Cavitron® ultrasonic scaler', 'type': 'DEVICE', 'description': 'Periodontal maintenance with ultrasonic scaler and manual curettes in periodontal patients.', 'armGroupLabels': ['Periodontal maintenance with ultrasonic + scaling and root planning']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46115', 'city': 'Alfara del Patriarca', 'state': 'Valencia', 'country': 'Spain', 'facility': 'Universidad CEU Cardenal Herrera', 'geoPoint': {'lat': 39.55, 'lon': -0.38333}}], 'overallOfficials': [{'name': 'Isidoro Cortell-Ballester, DDS, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cardenal Herrera University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cardenal Herrera University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Chirag Sheth', 'investigatorAffiliation': 'Cardenal Herrera University'}}}}