Ignite Creation Date:
2025-12-26 @ 11:49 AM
Ignite Modification Date:
2025-12-26 @ 11:49 AM
Study NCT ID:
NCT07124416
Status:
RECRUITING
Last Update Posted:
2025-08-15
First Post:
2025-07-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Impact of the Adequacy of Keratinized Mucosa on Peri-implant Tissue Health and Patient-reported Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-08', 'studyFirstSubmitDate': '2025-07-20', 'studyFirstSubmitQcDate': '2025-08-08', 'lastUpdatePostDateStruct': {'date': '2025-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Width of Keratinized Mucosa, KMW', 'timeFrame': 'on the day of enrollment'}, {'measure': 'Plaque Index(PI)', 'timeFrame': 'on the day of enrollment'}, {'measure': 'Bleeding on Probing(BOP)', 'timeFrame': 'on the day of enrollment'}, {'measure': 'Peri-implant Probing Depth(PPD)', 'timeFrame': 'on the day of enrollment'}, {'measure': 'Marginal Bone Loss(MBL)', 'timeFrame': 'The X-ray examination will be completed on the day of enrollment'}, {'measure': 'Patient Satisfaction', 'timeFrame': 'on the day of enrollment', 'description': 'visual analogue scale \\[VAS\\] 0-10,e.g., not at all satisfied to perfectly satisfied'}, {'measure': 'Immunological parameters in peri-implant crevicular fluids(PICF)', 'timeFrame': 'The PICF will be collected on the day of enrollment', 'description': 'PICF samples were collected from buccal aspects of implants after removing all supragingival plaque. The levels of IL-1β and PGE2 in PICF were measured using a sandwich ELISA kit.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Edentulous Alveolar Ridge']}, 'descriptionModule': {'briefSummary': 'This study aims to conduct a cross-sectional study to compare the differences in clinical indices, patient-reported outcomes, and levels of inflammatory factors in peri-implant gingival crevicular fluid between sites with adequate (≥ 2 mm) and inadequate (\\< 2 mm) keratinized mucosa after implant restoration, in order to explore the impact of the presence of keratinized mucosa on peri-implant soft and hard tissue health.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who have completed dental implant restoration（single crown or fixed bridge restorations） for at least 6 months and undergo routine follow-up examinations.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals aged 18 to 70 years (inclusive of 18 and 70 years), of any gender;\n* Patients who have undergone dental implant restoration是（single crown or fixed bridge restorations） at the Stomatology Hospital, Zhejiang University School of medicine and have had their final restoration for at least 6 months;\n* Patients who voluntarily participate and sign the informed consent form after being fully informed, and who cooperate with relevant examinations.\n\nExclusion Criteria:\n\n* Patients who are unwilling to participate in the follow-up of this study for various reasons'}, 'identificationModule': {'nctId': 'NCT07124416', 'briefTitle': 'The Impact of the Adequacy of Keratinized Mucosa on Peri-implant Tissue Health and Patient-reported Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'The Dental Hospital of Zhejiang University School of Medicine'}, 'officialTitle': 'The Impact of the Adequacy of Keratinized Mucosa on Peri-implant Tissue Health and Patient-reported Outcomes', 'orgStudyIdInfo': {'id': '2025-104'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'inadequate keratinized mucosa', 'description': 'peri-implant width of keratinized mucosa less than 2 mm'}, {'label': 'adequate keratinized mucosa', 'description': 'peri-implant width of keratinized mucosa ≥ 2 mm', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'No intervention: observational case-control study', 'armGroupLabels': ['adequate keratinized mucosa']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310000', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Misi Si', 'role': 'CONTACT', 'email': 'misi_si@zju.edu.cn', 'phone': '+86 18605712858'}], 'facility': 'The Stomatology Hospital, Zhejiang University School of Medicine', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Misi Si', 'role': 'CONTACT', 'email': 'misi_si@zju.edu.cn', 'phone': '+86 18605712858'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Dental Hospital of Zhejiang University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}