Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-25 @ 8:23 PM
Study NCT ID:
NCT07196969
Status:
COMPLETED
Last Update Posted:
2025-09-29
First Post:
2025-09-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Electric Toothbrushes on Periodontal Health and Oral Microbial Flora in Children With Space Maintainers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 84}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2023-04-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-21', 'studyFirstSubmitDate': '2025-09-21', 'studyFirstSubmitQcDate': '2025-09-21', 'lastUpdatePostDateStruct': {'date': '2025-09-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-04-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Plaque Index (PI)', 'timeFrame': 'Baseline (T0), 1 month (T1), and 3 months (T2).', 'description': 'Evaluation of plaque index scores using the Modified Silness and Löe Index.'}, {'measure': 'Change in Gingival Index (GI)', 'timeFrame': 'Baseline (T0), 1 month (T1), and 3 months (T2)', 'description': 'Evaluation of gingival index scores using the Gingival Index.'}, {'measure': 'Change in Bleeding on Probing (BOP)', 'timeFrame': 'Baseline (T0), 1 month (T1), and 3 months (T2)', 'description': 'Evaluation of bleeding on probing scores using the Bleeding on Probing (bop) Index'}, {'measure': 'Change in Periodontal Pocket Depth (PPD)', 'timeFrame': 'Baseline (T0), 1 month (T1), and 3 months (T2)', 'description': 'Evaluation of periodontal pocket depth (PPD)'}, {'measure': 'Change in salivary Streptococcus mutans levels', 'timeFrame': 'Baseline (T0), 1 month (T1), and 3 months (T2)'}, {'measure': 'Change in salivary Lactobacillus levels', 'timeFrame': 'Baseline (T0), 1 month (T1), and 3 months (T2)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Electric toothbrush', 'Manual toothbrush', 'Periodontal health', 'Pediatric dentistry', 'Space maintainers', 'Salivary microbiota'], 'conditions': ['Periodontal Parameters', 'Oral Microbial Colonization', 'Periodontal Health']}, 'descriptionModule': {'briefSummary': 'Objectives: To evaluate and compare the effects of electric and manual toothbrushes on periodontal health parameters and salivary microbial flora in children with fixed and removable space maintainers.\n\nMaterials and methods: Sixty-eight children (30 girls, 38 boys; mean age 8.8 years) requiring fixed (n=34) or removable (n=34) space maintainers were randomly allocated to electric (n=17) or manual (n=17) toothbrush subgroups. Periodontal indices; plaque index (PI), gingival index (GI), bleeding on probing (BOP), probing pocket depth (PPD) and salivary levels of Streptococcus mutans and Lactobacillus were assessed at baseline (T0), 1 month (T1), and 3 months (T2).', 'detailedDescription': "A total of 68 patients (thirty girls and thirty-eight boys), aged between 6 and 12 years (mean age 8.8), who received either fixed or removable space maintainers due to premature loss of primary molar teeth, were included in the study.\n\nPatients were randomized into two groups based on the type of space maintainer: fixed (n = 34) or removable (n = 34). Each group was further subdivided according to the type of toothbrush used: manual or electric, resulting in four subgroups (n=17). To standardize the study population, only band-and-loop appliances were used in the fixed space maintainer group, which were cemented using a fluoride-releasing glass ionomer cement (RelyX; 3M ESPE, St. Paul, MN, USA). Removable space maintainers consisted of an acrylic base with retention elements such as Adams' clasps, C clasps, or vestibular archesPatients in the removable space maintainer group were instructed to use their appliances during the day, except while eating and sleeping, and to clean them by brushing after toothbrushing."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children aged 6-12 years who required a space maintainer due to premature loss of primary molar teeth were included if they were medically healthy; had no periodontal disease, temporomandibular disorders, bruxism, abnormal oral habits, or physical/mental disabilities affecting hand movement; were not on regular medication; had not used antibiotics within the past three months or plaque-preventive agents within the last six months; and were able to comply with scheduled follow-up visits.\n\nExclusion Criteria:\n\n* Patients who failed to attend follow-up appointments or developed an infection/disease requiring antibiotic therapy during the study were excluded.'}, 'identificationModule': {'nctId': 'NCT07196969', 'briefTitle': 'Effects of Electric Toothbrushes on Periodontal Health and Oral Microbial Flora in Children With Space Maintainers', 'organization': {'class': 'OTHER', 'fullName': 'Pamukkale University'}, 'officialTitle': 'Effects of Electric and Manual Toothbrushes on Periodontal Health and Oral Microbial Flora in Children With Space Maintainers: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2022DİŞF002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Group I: Fixed Space Maintainer with Manual Toothbrush', 'description': 'In this group, patients with fixed space maintainers used manual toothbrushes (Oral-B Cavity Defense; Procter \\& Gamble, USA) during study period.', 'interventionNames': ['Device: Manual toothbrush']}, {'type': 'EXPERIMENTAL', 'label': 'Group II: Fixed Space Maintainer with Electric Toothbrush', 'description': 'In this group, patients with fixed space maintainers used electric toothbrushes (Oral-B Vitality Cross Action; Procter \\& Gamble, USA) during study period.', 'interventionNames': ['Device: Electric toothbrush']}, {'type': 'OTHER', 'label': 'Group III: Removable Space Maintainer with Manual Toothbrush', 'description': 'In this group, patients with removable space maintainers used manual toothbrushes (Oral-B Cavity Defense; Procter \\& Gamble, USA) during study period.', 'interventionNames': ['Device: Manual toothbrush']}, {'type': 'EXPERIMENTAL', 'label': 'Group IV: Removable Space Maintainer with Electric Toothbrush', 'description': 'In this group, patients with removable space maintainers used electric toothbrushes (Oral-B Vitality Cross Action; Procter \\& Gamble, USA) during study period.', 'interventionNames': ['Device: Electric toothbrush']}], 'interventions': [{'name': 'Electric toothbrush', 'type': 'DEVICE', 'description': 'Two minutes; twice a day; 3-months.', 'armGroupLabels': ['Group II: Fixed Space Maintainer with Electric Toothbrush', 'Group IV: Removable Space Maintainer with Electric Toothbrush']}, {'name': 'Manual toothbrush', 'type': 'DEVICE', 'description': 'Two minutes; twice a day; 3-months.', 'armGroupLabels': ['Group I: Fixed Space Maintainer with Manual Toothbrush', 'Group III: Removable Space Maintainer with Manual Toothbrush']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Denizli', 'country': 'Turkey (Türkiye)', 'facility': 'Pamukkale University Faculty of Dentistry', 'geoPoint': {'lat': 37.77417, 'lon': 29.0875}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pamukkale University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assist. Prof. Dr.', 'investigatorFullName': 'Arif Bolaca', 'investigatorAffiliation': 'Pamukkale University'}}}}