Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 2:27 AM
Study NCT ID:
NCT07480551
Status:
COMPLETED
Last Update Posted:
2026-03-20
First Post:
2026-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Direct Anterior Diastema Closure on Quality of Life and Dental Anxiety
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-03-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2025-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-18', 'studyFirstSubmitDate': '2026-03-14', 'studyFirstSubmitQcDate': '2026-03-14', 'lastUpdatePostDateStruct': {'date': '2026-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Oral Health-Related Quality of Life (OHIP-14 Score)', 'timeFrame': 'Baseline and 3 months after treatment', 'description': 'Oral health-related quality of life assessed using the Oral Health Impact Profile-14 (OHIP-14). The total score ranges from 0 to 56, with higher scores indicating poorer oral health-related quality of life.'}, {'measure': 'Change in Dental Anxiety (MDAS Score)', 'timeFrame': 'Baseline and 3 months after treatment', 'description': 'Dental anxiety assessed using the Modified Dental Anxiety Scale (MDAS). Total scores range from 5 to 25, with higher scores indicating greater dental anxiety.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Maxillary Anterior Diastema']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the effects of non-invasive direct anterior diastema closure on dental anxiety and oral health-related quality of life in adults with maxillary anterior diastema. Direct composite resin restorations are widely used for diastema closure due to their minimally invasive nature, cost-effectiveness, and ability to be completed in a single clinical visit. However, limited information is available regarding the psychological and quality-of-life outcomes of this treatment.\n\nIn this prospective single-arm clinical study, adult participants presenting with anterior diastema receive non-invasive direct composite restorations for diastema closure. Dental anxiety and oral health-related quality of life are assessed using the Modified Dental Anxiety Scale (MDAS) and the Oral Health Impact Profile-14 (OHIP-14). Participants complete these questionnaires before treatment and three months after the restorative procedure. The study aims to determine whether direct anterior diastema closure improves oral health-related quality of life and reduces dental anxiety in affected individuals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 18 years or older\n* Absence of previous restorative treatment (including restorative, endodontic, or prosthetic procedures)\n* Periodontally healthy teeth\n* Presence of anterior diastema with a width of less than 2 mm\n* Absence of malocclusion\n* Good general systemic health\n* No use of anxiety-reducing pharmacological agents (e.g., sedatives, anxiolytics, or analgesics) prior to treatment\n\nExclusion Criteria:\n\n* Presence of cognitive or psychiatric disorders\n* History of substance abuse\n* Presence of malignant diseases\n* Presence of acute dental or periodontal conditions'}, 'identificationModule': {'nctId': 'NCT07480551', 'briefTitle': 'Effect of Direct Anterior Diastema Closure on Quality of Life and Dental Anxiety', 'organization': {'class': 'OTHER', 'fullName': 'Recep Tayyip Erdogan University'}, 'officialTitle': 'Effect of Direct Anterior Diastema Closure Treatment on Oral Health-related Quality of Life and Dental Anxiety', 'orgStudyIdInfo': {'id': 'Recep Tayyip Erdogan Universit'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Direct Anterior Diastema Closure', 'description': 'Participants with maxillary anterior diastema received non-invasive direct anterior diastema closure using direct composite resin restorations.', 'interventionNames': ['Procedure: Direct Composite Resin Restoration for Anterior Diastema Closure']}], 'interventions': [{'name': 'Direct Composite Resin Restoration for Anterior Diastema Closure', 'type': 'PROCEDURE', 'description': 'Non-invasive direct anterior diastema closure was performed using direct composite resin restorations following standard adhesive procedures.', 'armGroupLabels': ['Direct Anterior Diastema Closure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53020', 'city': 'Rize', 'country': 'Turkey (Türkiye)', 'facility': 'Recep Tayyip Erdoğan University Faculty of Dentistry', 'geoPoint': {'lat': 41.02083, 'lon': 40.52194}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Recep Tayyip Erdogan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant professor', 'investigatorFullName': 'fatih bedir', 'investigatorAffiliation': 'Recep Tayyip Erdogan University'}}}}