Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2026-01-04 @ 11:12 PM
Study NCT ID:
NCT05312593
Status:
COMPLETED
Last Update Posted:
2024-06-25
First Post:
2022-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Domiciliary Use of Hyaluronic Acid Gel Solutions vs Domiciliary Use of Chlorhexidine Mouthwash 0,20% for the Management of Peri-implant Mucositis Sites
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2022-11-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-23', 'studyFirstSubmitDate': '2022-03-26', 'studyFirstSubmitQcDate': '2022-03-26', 'lastUpdatePostDateStruct': {'date': '2024-06-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Probing Depth (PD)', 'timeFrame': 'Baseline (T0), after 1 (T1), 3 (T2), 6 (T3), 9 (T4) and 12 months (T5)', 'description': 'Evaluation (in mm) of the depth of the gingival sulcus, through a millimeter periodontal PEEK probe; it is detected from the gingival margin to the bottom of the gingival sulcus or periodontal pocket, evaluated at 6 sites.'}, {'measure': 'Change in Bleeding on Probing (BOP%)', 'timeFrame': 'Baseline (T0), after 1 (T1), 3 (T2), 6 (T3), 9 (T4) and 12 months (T5)', 'description': 'Quantitative assessment (percentage) of the bleeding sites (6 per tooth in total).\n\nFormula = n ° bleeding sites / n ° probed sites x100'}, {'measure': 'Change in Bleeding Score (BS - Mombelli et al.)', 'timeFrame': 'Baseline (T0), after 1 (T1), 3 (T2), 6 (T3), 9 (T4) and 12 months (T5)', 'description': 'Scoring criteria:\n\n0: no bleeding\n\n1. isolated visible spots\n2. blood forms a confluent red line on the mucosal margin\n3. profuse and copious bleeding'}, {'measure': 'Change in Plaque Control Record (PCR%)', 'timeFrame': 'Baseline (T0), after 1 (T1), 3 (T2), 6 (T3), 9 (T4) and 12 months (T5)', 'description': 'Evaluation of the presence of plaque on the 4 surfaces of teeth on the total amount of dental surfaces.\n\nFormula = n ° sites with plaque / total n ° of dental surfaces x100'}, {'measure': 'Change in marginal mucosa condition', 'timeFrame': 'Baseline (T0), after 1 (T1), 3 (T2), 6 (T3), 9 (T4) and 12 months (T5)', 'description': 'Scoring criteria:\n\n0: normal mucosa\n\n1. minimal inflammation with color change and minor edema\n2. moderate inflammation with redness, edema and glazing\n3. severe inflammation with redness, edema, ulceration and spontaneous bleeding without probing'}, {'measure': 'Change in Suppuration (%)', 'timeFrame': 'Baseline (T0), after 1 (T1), 3 (T2), 6 (T3), 9 (T4) and 12 months (T5)', 'description': 'Dichotomous scoring (yes/no) of suppurating sites'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hyaluronic acid', 'chrlorhexidine', 'non-surgical periodontal therapy'], 'conditions': ['Peri-implant Mucositis']}, 'descriptionModule': {'briefSummary': 'This is a randomized controlled clinical trial (RCT). After signing the informed consent, patients satisfying the inclusion criteria will undergo supragingival and subgingival professional oral hygiene of both arches performed with ultrasonic instrumentation with PEEK inserts, manual instrumentation with PEEK curettes and air polishing with glycine powder.\n\nAfter that, the sample will be randomly divided into 2 groups based on the domiciliary assigned treatment:\n\n* Aftoral® Oral Gel solution with Hyaluronic Acid, Xylitol and glycerophosphoinositol for the domiciliary use for 15 days for 2 peri-implant mucositis sites.\n* Unidea® Chlorhexidine digluconate Mouthwash 0,20% administration for the domiciliary application for 15 days for 2 peri-implant sites.\n\nThe study will last 6 months. Patients will be visited at: T0, after 1 month from T0 (T1), after 3 months (T2), after 6 months (T3), after 9 months (T4) and after 12 months (T5). Professional hygiene will be performed again at T3.\n\nAt each recall session were collected a satisfaction questionnaire of the products (taste, smell, consistency, persistence and ease of application) and the following periodontal clinical indices, using a PEEK probe on each peri-implant site:\n\n* conditions of the marginal mucosa (swelling and erythema),\n* migration of the marginal mucosa,\n* PPD (Probing Pocket Depth),\n* BOP% (Bleeding on Probing),\n* BS (Bleeding Score),\n* Suppuration,\n* PCR% (Plaque Control Record),', 'detailedDescription': 'This is a randomized controlled clinical trial (RCT). 60 patients are expected to be enrolled. After signing the informed consent, patients satisfying the inclusion criteria will undergo supragingival and subgingival professional oral hygiene of both arches performed with ultrasonic instrumentation with PEEK inserts, manual instrumentation with PEEK curettes and air polishing with glycine powder.\n\nAfter that, the sample will be randomly divided into 2 groups based on the domiciliary assigned treatment:\n\n* Aftoral® Oral Gel solution with Hyaluronic Acid, Xylitol and glycerophosphoinositol for the domiciliary use for 15 days for 2 peri-implant mucositis sites.\n* Unidea® Chlorhexidine digluconate Mouthwash 0,20% administration for the domiciliary application for 15 days for 2 peri-implant sites.\n\nThe study will last 6 months. Patients will be visited at: T0, after 1 month from T0 (T1), after 3 months (T2), after 6 months (T3), after 9 months (T4) and after 12 months (T5).\n\nAt T3, professional hygiene will be performed again.\n\nAt each recall session were collected a satisfaction questionnaire of the products (taste, smell, consistency, persistence and ease of application) and the following periodontal clinical indices, using a PEEK probe on each peri-implant site:\n\n* conditions of the marginal mucosa (swelling and erythema),\n* Marginal mucosal condition,\n* PPD (Probing Pocket Depth),\n* BOP% (Bleeding on Probing),\n* BS (Bleeding Score),\n* Suppuration,\n* PCR% (Plaque Control Record).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 18-70 years\n* presence of at least one site suffering from peri-implant mucositis with PPD \\> or equal to 5 mm\n* no systemic, metabolic and autoimmune disease\n* compliant patients\n\nExclusion Criteria:\n\n* absence of dental implants\n* neurologic, psychiatric and mental diseases\n* patients taking bisphosphonates in the last 12 months\n* patients taking antibiotics during the study\n* pregnant and breastfeeding women\n* patients undergoing anticancer treatment\n* allergy to chlorhexidine or hyaluronic acid\n* sites with peri-implantitis'}, 'identificationModule': {'nctId': 'NCT05312593', 'briefTitle': 'Domiciliary Use of Hyaluronic Acid Gel Solutions vs Domiciliary Use of Chlorhexidine Mouthwash 0,20% for the Management of Peri-implant Mucositis Sites', 'organization': {'class': 'OTHER', 'fullName': 'University of Pavia'}, 'officialTitle': 'Domiciliary Use of Hyaluronic Acid Gel Solutions vs Domiciliary Use of Chlorhexidine Mouthwash 0,20% for the Management of Peri-implant Mucositis Sites: a Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '2022-AFTORAL IMPL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Trial Group', 'description': 'A group of 30 patients will be randomly assigned to Hyaluronic Acid domiciliary treatment, applied into Peri-implant mucositis sites.', 'interventionNames': ['Other: Aftoral Oral Gel']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'A group of 30 patients will be randomly assigned to Chlorhexidine mouthwash domiciliary treatment, applied into Peri-implant mucositis sites.', 'interventionNames': ['Other: Unidea Chlorhexidine mouthwash']}], 'interventions': [{'name': 'Aftoral Oral Gel', 'type': 'OTHER', 'description': 'Patients will use Aftoral® Oral Gel solution for the domiciliary application once a day for 15 days after the visits (no rinsing and eating for 30 minutes after gel solution application).', 'armGroupLabels': ['Trial Group']}, {'name': 'Unidea Chlorhexidine mouthwash', 'type': 'OTHER', 'description': 'Patients will use chlorhexidine mouthwash 0,20% for the domiciliary application once a day for 15 days after the visits (no rinsing and eating for 30 minutes after mouthwash application).', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27100', 'city': 'Pavia', 'state': 'Lombardy', 'country': 'Italy', 'facility': 'Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}], 'overallOfficials': [{'name': 'Andrea Scribante, DDS, PhD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pavia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data will be available upon motivated request to the Principal Investigator.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pavia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, Principal Investigator', 'investigatorFullName': 'Andrea Scribante', 'investigatorAffiliation': 'University of Pavia'}}}}