Ignite Creation Date:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2026-01-07 @ 12:23 PM
Study NCT ID:
NCT06144034
Status:
COMPLETED
Last Update Posted:
2023-11-22
First Post:
2023-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Air Polishing Effect on Biological, Clinical and Patient-reported Experience Among Epileptic and Non-epileptic Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004827', 'term': 'Epilepsy'}, {'id': 'D005891', 'term': 'Gingivitis'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D005882', 'term': 'Gingival Diseases'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012123', 'term': 'Pulmonary Ventilation'}], 'ancestors': [{'id': 'D012129', 'term': 'Respiratory Function Tests'}, {'id': 'D003948', 'term': 'Diagnostic Techniques, Respiratory System'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D012143', 'term': 'Respiratory Physiological Phenomena'}, {'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Outcomes Assessor was blinded to treatment intervention'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Split-Mouth Design Clinical Trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-06-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-20', 'studyFirstSubmitDate': '2023-11-13', 'studyFirstSubmitQcDate': '2023-11-20', 'lastUpdatePostDateStruct': {'date': '2023-11-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gingival inflammation', 'timeFrame': 'Before treatment began, and two weeks after treatment.', 'description': 'using Loe and Silness gingival index. Before biofilm disclosing, evaluated by assigning scores from 0-3 for gingival inflammation at four sites (mesial, distal, buccal, and lingual/palatal) per tooth, 0- normal gingiva and 3 - severely inflamed'}, {'measure': 'Mean Marginal Plaque', 'timeFrame': 'Before treatment began, immediately after, and two weeks after treatment.', 'description': "O'Leary Plaque Index on 6 sites per tooth, 0= absence of plaque or 1= presence of plaque"}, {'measure': 'patient satisfaction', 'timeFrame': 'immediately after treatments of each quadrant.', 'description': 'Likert Faces 5-points satisfaction scale, 0-4, 0 = Very dissatisfied. 4= Very satisficed'}, {'measure': 'Treatment duration', 'timeFrame': 'from the time procedure begins until removing all dental biofilm and calculus', 'description': 'for each quadrant, time was measured from beginning of treatment till biofilm and calculus are fully removed per seconds'}, {'measure': 'Pain measure', 'timeFrame': 'immediately after treatments of each quadrant.', 'description': 'Faces pain scale-Revised 0-10, 0 no pain, 10 maximum pain'}, {'measure': 'patient satisfaction', 'timeFrame': 'immediately after treatments of each quadrant.', 'description': 'two questions, Which treatment method was less painful, Which treatment would you do again?'}], 'secondaryOutcomes': [{'measure': 'Biomarkers', 'timeFrame': 'Before treatment began, and two weeks after treatment.', 'description': 'Gingival crevicular fluid samples IL-1B and MMP-8 two samples per patient, one for each treatment method'}, {'measure': 'Residual plaque area', 'timeFrame': 'Before treatment began, immediately after, and two weeks after treatment.', 'description': 'Rustogi modified Navy plaque index'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Air polishing', 'Airflow', 'Erythritol', 'Oral health of special healthcare needs children'], 'conditions': ['Epilepsy', 'Gingivitis']}, 'descriptionModule': {'briefSummary': 'In epileptic and non Epileptic children, the full dentition of each patient was split into four quadrants, starting from the upper right quadrant (1) and moving clockwise until the lower right quadrant (4). Bundled into two groups: quadrant (1+3) vs. (2+4). After randomization, each of these pairs of quadrants had the same treatment modality; test quadrants received treatment with airflow to remove soft biofilm, and ultrasonic scaler for areas with calculus deposits, and control quadrants were treated with conventional rubber cup polishing to remove soft biofilm and ultrasonic scaler for calculus deposits.', 'detailedDescription': "The treatment of each quadrant was administered sequentially, beginning with the upper right quadrant. Treatment duration was measured in seconds from the start of treatment in each quadrant until the removal of all disclosed biofilm and calculus. This process was repeated for each quadrant individually. And intra-oral photographs were taken before, immediately after treatment, and at follow-up time.\n\nConventional treatment was conducted after biofilm disclosure by a rubber cup and prophylaxis paste spearmint (Kemdent Works, Purton. Swindon, Wiltshire. SN5 4HT, UK). The power setting was between 70% and 100%. The rubber cup was used until all biofilm was removed, then, if present, calculus was removed by Electro Medical Systems (EMS) ultrasonic scaler with a power setting between 3-6 on the Airflow control panel.\n\nFor Airflow, treatment was conducted after biofilm disclosure. The powder chamber of the air polishing device was filled with low-abrasive erythritol powder, according to the manufacturer's instructions. The tip of the handpiece was positioned at an angle of 70° to the surface of the tooth to be polished at 3 mm from the tooth surface. Once activated, a non-stop movement from mesial to distal and distal to mesial in a smiley face shape starting from the gingival sulcus and moving upwards coronally to the incisal to cover the entire clinical crown was performed, with a power setting ranging from 3-6 on the control panel of the airflow device. EMS ultrasonic scaler was used to remove calculus if present with a power ranging from 3-6."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '5 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* children aged 5 to 15 years with epilepsy\n* on anti-epileptic drugs (AED) for at least 3 months\n* periodontal pockets depths not exceeding 3mm\n* full-mouth plaque scores over 50%, and having 5 teeth per quadrant.\n* The non-epileptic group included healthy non-epileptic children meeting similar criteria for age, periodontal health, and plaque scores\n\nExclusion Criteria:\n\n* coexisting neurological illnesses other than epilepsy, medical conditions impacting oral health, periodontitis, asthma, swallowing difficulties, intellectual disabilities, and non-ambulatory status'}, 'identificationModule': {'nctId': 'NCT06144034', 'briefTitle': 'Air Polishing Effect on Biological, Clinical and Patient-reported Experience Among Epileptic and Non-epileptic Children', 'organization': {'class': 'OTHER', 'fullName': 'King Abdullah University Hospital'}, 'officialTitle': 'Effect of Air Polishing for Biofilm Removal on Clinical, Biological, and Patient-Reported Experience Among Epileptic and Non-Epileptic Children: A Split-Mouth Randomised Clinical Trial', 'orgStudyIdInfo': {'id': '635-2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Epilepsy patients', 'description': '1 and 3 quadrants got the same treatment and 2 and 4 got the same treatment. Air polishing with erythritol powder was used to remove biofilm and EMS ultrasonic scaler to remove calculus if present. also rubber cup and prophylaxis paste spearmint (Kemdent Works, Purton. Swindon, Wiltshire. SN5 4HT, UK). and EMS ultrasonic scaler to remove calculus if present.', 'interventionNames': ['Device: Air polishing with erythritol powder', 'Device: Conventional treatment']}, {'type': 'EXPERIMENTAL', 'label': 'Non-epileptic pateints', 'description': '1 and 3 quadrants got the same treatment and 2 and 4 got the same treatment. Air polishing with erythritol powder was used to remove biofilm and EMS ultrasonic scaler to remove calculus if present. also rubber cup and prophylaxis paste spearmint (Kemdent Works, Purton. Swindon, Wiltshire. SN5 4HT, UK). and EMS ultrasonic scaler to remove calculus if present.', 'interventionNames': ['Device: Air polishing with erythritol powder', 'Device: Conventional treatment']}], 'interventions': [{'name': 'Air polishing with erythritol powder', 'type': 'DEVICE', 'otherNames': ['Airflow'], 'description': 'Air polishing with erythritol powder utilized for biofilm disclosing and, followed by an ultrasonic scaler to remove calculus if present.', 'armGroupLabels': ['Epilepsy patients', 'Non-epileptic pateints']}, {'name': 'Conventional treatment', 'type': 'DEVICE', 'otherNames': ['Rubber cup polishing'], 'description': 'Rubber cup polishing with prophy paste after biofilm disclosing, followed by ultrasonic scaling of calculus if present.', 'armGroupLabels': ['Epilepsy patients', 'Non-epileptic pateints']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21110', 'city': 'Irbid', 'country': 'Jordan', 'facility': 'Jordan Univerity of Science and technology', 'geoPoint': {'lat': 32.55556, 'lon': 35.85}}, {'zip': '21110', 'city': 'Irbid', 'country': 'Jordan', 'facility': 'Jordan University of Science and Technology', 'geoPoint': {'lat': 32.55556, 'lon': 35.85}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'King Abdullah University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}