Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2026-01-02 @ 1:15 PM
Study NCT ID:
NCT04640857
Status:
COMPLETED
Last Update Posted:
2023-04-04
First Post:
2020-11-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Influence of Radiofrequency-based Toothbrush on the Accumulation of Calculus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': "Experimental: Silk'n Toothwave"}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 99}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2022-06-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-02', 'studyFirstSubmitDate': '2020-11-01', 'studyFirstSubmitQcDate': '2020-11-17', 'lastUpdatePostDateStruct': {'date': '2023-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Plaque score %', 'timeFrame': 'baseline (T0), after 4 weeks (T1), after 12 weeks (Tf)', 'description': 'to estimate the presence of plaque and its accumulation on the tooth surface of anterior mandibular incisors'}, {'measure': 'Change in Calculus ratio %', 'timeFrame': 'baseline (T0), after 4 weeks (T1), after 12 weeks (Tf)', 'description': 'to estimate the percentage of calculus on the lingual aspect of anterior mandibular incisors using ImageJ software'}, {'measure': 'Change in Free gingival margin color (CEILAB color space)', 'timeFrame': 'baseline (T0), after 4 weeks (T1), after 12 weeks (Tf)', 'description': 'the color of the gingiva will be measured with the software Adobe photoshop and will be calculated with CIELAB color space.'}], 'secondaryOutcomes': [{'measure': 'Probing depth mm', 'timeFrame': 'baseline (T0), after 4 weeks (T1), after 12 weeks (Tf)', 'description': 'to measure the pocket depths around the anterior mandibular incisors'}, {'measure': 'Bleeding on probing Yes/No', 'timeFrame': 'baseline (T0), after 4 weeks (T1), after 12 weeks (Tf)', 'description': 'to document the presence or absence of bleeding of the dental pocket after probing'}, {'measure': 'Recession mm', 'timeFrame': 'baseline (T0), after 4 weeks (T1), after 12 weeks (Tf)', 'description': 'to measure the discrepancy (if existent) between the cementoenamel junction and the free gingival margin in the buccal aspect of the anterior mandibular incisors'}, {'measure': 'Subject satisfaction questionnaire', 'timeFrame': '4 weeks (T1), after 12 weeks (Tf)', 'description': 'the questionnaire includes 4 questions: satisfaction, convenience, improvement in oral hygiene and the quality of brushing'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Electromagnetic Fields', 'Oral Hygiene'], 'conditions': ['Oral Hygiene']}, 'referencesModule': {'references': [{'pmid': '37515446', 'type': 'DERIVED', 'citation': 'Khoury J, Giladi HZ, Ginesin O, Gabay E, Mayer Y. The influence of radio frequency-based toothbrush on the accumulation of calculus and periodontal health: A randomized double-blind controlled prospective study. Clin Exp Dent Res. 2023 Aug;9(4):574-585. doi: 10.1002/cre2.770. Epub 2023 Jul 29.'}]}, 'descriptionModule': {'briefSummary': "to evaluate the influence of radiofrequency based toothbrush (Silk'n toothwave)on the accumulation of the calculus", 'detailedDescription': "Calculus is a white-brownish layer with various levels of stiffness, which accumulates on teeth and is formed by the mineralization of dental plaque.\n\nThus, maintaining oral hygiene and adhering to maintenance programs keep low levels of plaque and calculus.\n\nThe electromagnetic field is known for bone healing by lessening osteoclast activity, improving osteoid formation, and stimulating angiogenesis. Furthermore, the electromagnetic field has an antimicrobial effect.\n\nElectric toothbrushes have shown a statistical reduction in plaque accumulation and gingival inflammation.\n\nPrevious studies have shown that Silk'n Toothwave results in less plaque accumulation and calculus formation, in addition to stain removal and teeth whitening.\n\nStudy aim: to asses the effect of the electromagnetic field in a tooth brush (Silk'n Toothwave) on calculus accumulation and gingival parameters."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female patient aged 20-85 Years old\n* Subject must have voluntarily signed the informed consent form before any study related action\n* Presence of gingival inflammation (Gingival Index by Silness and Loe 1969)\n* Presence of plaque on clinical crowns (calculation of area)\n* Supportive periodontal therapy (with ultra-sonic and manual devices) on a regular basis with a 3-month interval with a minimum of 3 times in a row prior to T0 (baseline)\n* Compliance with study schedules and arrival at study visits\n\nExclusion Criteria:\n\n* A systemic or pharmacological condition that can affect the healing of soft or hard tissue in the rest of the teeth or implants such as cyclosporine, calcium channel blockers\n* Pregnant or lactating women (\\*If Male Please write N/A).\n* Heavy smokers (more than 10 cigarettes per day).\n* Patients with a pacemaker that do not allow the use of an ultrasonic device.\n* Patient with an active periodontal disease (may undergo periodontal treatment as required and not completed as part of the study if it can be included in the study).\n* Systemic condition requiring prophylactic antibiotics.\n* Patients taking NSAIDS for prolonged period.'}, 'identificationModule': {'nctId': 'NCT04640857', 'briefTitle': 'Evaluation of the Influence of Radiofrequency-based Toothbrush on the Accumulation of Calculus', 'organization': {'class': 'OTHER', 'fullName': 'Rambam Health Care Campus'}, 'officialTitle': 'Randomized Double Blind Controlled Prospective Study to Evaluate the Influence of Radiofrequency Based Toothbrush on the Accumulation of the Calculus', 'orgStudyIdInfo': {'id': '0352-20-RMB CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': "Test group: Silk'n Toothwave with vibration and electromagnetic field", 'description': "Silk'n Toothwave with vibration and electromagnetic field use twice a day for 3 months.", 'interventionNames': ["Device: Silk'n Toothwave"]}, {'type': 'SHAM_COMPARATOR', 'label': "Control group: Silk'n Toothwave with-out an electromagnetic field ( only vibration)", 'description': "Silk'n Toothwave without an electromagnetic field (only vibration ) use twice a day for 3 months.", 'interventionNames': ["Device: Silk'n Toothwave"]}, {'type': 'ACTIVE_COMPARATOR', 'label': "Silk'n Toothwave with an electromagnetic field and without vibration", 'description': "Silk'n Toothwave with an electromagnetic field and without vibration use twice a day for 3 months.", 'interventionNames': ["Device: Silk'n Toothwave"]}], 'interventions': [{'name': "Silk'n Toothwave", 'type': 'DEVICE', 'description': 'patients will receive a non-surgical treatment which will include oral hygiene instructions, calculus removal with ultrasonic and manual instruments. At the end of the meeting they will be provided with a toothbrush which is based on a radiofrequency technology.', 'armGroupLabels': ["Control group: Silk'n Toothwave with-out an electromagnetic field ( only vibration)", "Silk'n Toothwave with an electromagnetic field and without vibration", "Test group: Silk'n Toothwave with vibration and electromagnetic field"]}]}, 'contactsLocationsModule': {'locations': [{'zip': '31096', 'city': 'Haifa', 'country': 'Israel', 'facility': 'Rambam Health Care Campus, Dept. of Periodontology', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}], 'overallOfficials': [{'name': 'Hadar Zigdon, DMD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rambam Health Care Campus'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rambam Health Care Campus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}