Ignite Creation Date:
2025-12-24 @ 2:19 PM
Ignite Modification Date:
2026-03-06 @ 12:25 AM
Study NCT ID:
NCT06725095
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-06-04
First Post:
2024-12-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Enamel Matrix Derivative in the Treatment of Peri-implant Mucositis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D052016', 'term': 'Mucositis'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Sealed envelopes'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 54}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-12-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-06-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-30', 'studyFirstSubmitDate': '2024-12-05', 'studyFirstSubmitQcDate': '2024-12-05', 'lastUpdatePostDateStruct': {'date': '2025-06-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bleeding on probing (BOP) changes', 'timeFrame': '6-months', 'description': 'The number of implants presenting with complete absence of BOP or implants with limited extent of BOP (≤1 spot/implant-the presence of a single spot)'}], 'secondaryOutcomes': [{'measure': 'Probing pocket depth (PPD) changes', 'timeFrame': '6-months', 'description': 'Changes in PPD'}, {'measure': 'Full mouth plaque score (FMPS) % changes', 'timeFrame': '6-months', 'description': 'Full mouth plaque score (FMPS) % changes'}, {'measure': 'Full mouth bleeding score (FMBS) % changes', 'timeFrame': '6-months', 'description': 'Changes in FMBS'}, {'measure': 'Plaque at implant sites according to modified gingival index (mGI) changes score', 'timeFrame': '6-months', 'description': 'Changes in mGI 0-4 score'}, {'measure': 'Plaque at implant sites according to modified plaque index (mPlI) changes score', 'timeFrame': '6-months', 'description': 'Changes in mPlI 0-4 score'}, {'measure': 'Patient-Reported Outcome Measures (PROMs)', 'timeFrame': '6-months', 'description': 'Patient-Reported Outcome Measures (PROMs) Were evaluated PROMs such as the number of abscesses, systemic complications, gingival recession, excessive bleeding, allergic effects, systemic impacts and related drug side effects'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Enamel matrix derivative'], 'conditions': ['Mucositis', 'Peri Implant Mucositis']}, 'descriptionModule': {'briefSummary': 'To evaluate the naturally occurring peri-implant mucositis (PM) treatment by means of non-surgical sub-marginal peri-implant instrumentation (NSPI) with or without use of enamel matrix protein derivative (EMD). Specifically, the primary outcome of the present study compared the efficacy of NSPI +EMD with respect to NSPI and placebo in the treatment of PM at 6 months follow-up by means of BOP reduction. The secondary outcome evaluated the influence of possible predictors on the BOP changes among all follow-up sessions.', 'detailedDescription': 'Patients (n° 54) with Implants affected by PM were randomly assigned to test (NSMD+EMD) or control procedures (NSMD + placebo). At baseline, 1, 3, 6 months, full-mouth plaque score (FMPS), full-mouth bleeding score (FMBS), probing depth (PD), bleeding on probing (BOP), modified gingival index (mGI), and modified plaque index (mPlI) will assessed as well as levels of periodontal bacteria such as Aggregatibacter Actynomycencomitans, Porphyromonas Gingivalis, Tannerella Forsythia and Treponema Denticola. The BOP reduction was set as a primary outcome and the patient was considered statistical unit. Data were analysed to assess BOP reduction at a 6-month follow-up and to identify significant predictors of implant-site BOP through mixed generalized linear regression.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age ≥18 years old;\n* implants with smooth necks supporting cemented or screw-retained single-unit crowns with at least one BOP-positive site (Berglundh et al., 2018),\n* implants placed in both maxilla and mandible\n* patients with gingivitis or treated periodontitis with the absence of residual PD ≥5 mm\n* presence at least of 2 mm of keratinized mucosa (KT) at implant sites\n\nExclusion Criteria:\n\n* presence of systemic diseases;\n* pregnancy or lactating;\n* use of inflammatory drugs or antibiotics within 3 months prior to study recruitment;\n* implants with modified (i.e., micro-rough) necks;\n* interproximal open contacts between implant restoration and adjacent teeth; peri-implantitis (Berglundh et al., 2018)'}, 'identificationModule': {'nctId': 'NCT06725095', 'briefTitle': 'Effects of Enamel Matrix Derivative in the Treatment of Peri-implant Mucositis', 'organization': {'class': 'OTHER', 'fullName': 'University of Catania'}, 'officialTitle': 'Effects of Enamel Matrix Derivative in the Non-surgical Mechanical Debridement Treatment of Peri-implant Mucositis', 'orgStudyIdInfo': {'id': '2024-3306'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Comparator: non-surgical sub-marginal peri-implant instrumentation (NSPI) with placebo gel', 'description': 'Patients received a one-session of non-surgical sub-marginal peri-implant instrumentation (NSPI) with placebo', 'interventionNames': ['Other: Placebo gel']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'non-surgical sub-marginal peri-implant instrumentation (NSPI) with EMD', 'description': 'Patients received a one-session of non-surgical sub-marginal peri-implant instrumentation (NSPI) with EMD', 'interventionNames': ['Other: Enamel Matrix Proteins Derivative']}], 'interventions': [{'name': 'Placebo gel', 'type': 'OTHER', 'description': 'Patients were treated with non surgical peri-implant mucositis therapy with non-surgical sub-marginal peri-implant instrumentation plus the use of a placebo gel', 'armGroupLabels': ['Placebo Comparator: non-surgical sub-marginal peri-implant instrumentation (NSPI) with placebo gel']}, {'name': 'Enamel Matrix Proteins Derivative', 'type': 'OTHER', 'description': 'Patients were treated with non surgical peri-implant mucositis therapy with non-surgical sub-marginal peri-implant instrumentation plus the use of non-surgical treatment plus Enamel Matrix Proteins Derivative', 'armGroupLabels': ['non-surgical sub-marginal peri-implant instrumentation (NSPI) with EMD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95124', 'city': 'Catania', 'state': 'Ct', 'country': 'Italy', 'facility': 'Policlinico G. Rodolico', 'geoPoint': {'lat': 37.49223, 'lon': 15.07041}}], 'overallOfficials': [{'name': 'Gaetano Isola, DDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Catania'}]}, 'ipdSharingStatementModule': {'url': 'https://pubmed.ncbi.nlm.nih.gov/', 'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': '6 months', 'ipdSharing': 'YES', 'description': 'Pubmed', 'accessCriteria': 'pubmed databse'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Catania', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Gaetano Isola', 'investigatorAffiliation': 'University of Catania'}}}}