Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2025-12-25 @ 11:22 PM
Study NCT ID:
NCT07196293
Status:
COMPLETED
Last Update Posted:
2025-09-29
First Post:
2025-09-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Comparison Between Protemp and Flowable Light Cure Composite Material for Creating Optimal Gingival Emergence Profile Around Implant
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-19', 'studyFirstSubmitDate': '2025-09-14', 'studyFirstSubmitQcDate': '2025-09-19', 'lastUpdatePostDateStruct': {'date': '2025-09-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gingival Index (GI)', 'timeFrame': 'T1: Immediately after the placement of the final prosthesis. T2: At the one-month follow-up appointment.', 'description': 'Gingival Index (GI): This index is used to evaluate inflammation of the gums around the implant.\n\nScale: 0 to 3.\n\nInterpretation: A higher score indicates a worse outcome, signifying greater gingival inflammation.'}, {'measure': 'Probing depth (PI)', 'timeFrame': 'T1: Immediately after the placement of the final prosthesis. T2: At the one-month follow-up appointment.', 'description': 'Probing Depth (PD): This is a direct clinical measurement, not a scored scale, taken in millimeters at six points around the implant.\n\nInterpretation: Deeper measurements are generally associated with less healthy peri-implant tissue. Therefore, a lower value indicates a better clinical outcome.'}, {'measure': 'Pink Esthetic Score (PES)', 'timeFrame': 'T1: Immediately after the placement of the final prosthesis. T2: At the one-month follow-up appointment.', 'description': 'Pink Esthetic Score (PES): This score is used to assess the aesthetic quality of the soft tissue surrounding the implant restoration.\n\nScale: 0 to 14.\n\nInterpretation: A higher score indicates a better and more aesthetically pleasing outcome.'}, {'measure': 'Pain Numeric Scale', 'timeFrame': 'T1: Immediately after the placement of the final prosthesis. T2: At the one-month follow-up appointment.', 'description': 'Pain Numeric Rating Scale (NRS): This scale measures the patient\'s subjective experience of pain during the insertion of the final prosthesis.\n\nScale: 0 ("no pain") to 10 ("worst pain imaginable").\n\nInterpretation: A higher score indicates a worse outcome, representing more severe pain.'}], 'secondaryOutcomes': [{'measure': 'Plaque Index (PI)', 'timeFrame': 'T2: At the one-month follow-up appointment.', 'description': 'Plaque Index (PI): This index is used to quantify the amount of dental plaque present on the implant restoration.\n\nScale: 0 to 3.\n\nInterpretation: A higher score indicates a worse outcome, corresponding to a greater accumulation of plaque.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Customized Healing Abutment', 'Dental Implant', 'Composite Resin', 'Peri-Implant Health']}, 'descriptionModule': {'briefSummary': 'The study focuses on the critical role of the gingival emergence profile in the success of dental implants, emphasizing its importance for both peri-implant health and esthetics. The research aims to evaluate and compare the effectiveness of two common, cost-effective dental materials-light-cure composite and Protemp (a bis-acryl composite resin)-for fabricating customized healing abutments. By assessing the peri-implant tissue response to these materials, the study seeks to determine which is more suitable for creating an optimal, natural-looking soft tissue contour, thereby providing dentists with a practical and reliable alternative to more expensive options like PEEK.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18 and 65 years.\n* Edentulous spaces to be replaced with implant-supported single crowns.\n* Antagonistic natural tooth present and sound (sound periodontium) (Stable occlusion and opposing dentition)\n* Good general periodontal health\n* Good general health.\n* Willing to participate in the study and able to sign informed consent. (Ability to attend all follow-up appointments.)\n\nExclusion Criteria:\n\n* Untreated caries or periapical lesions in the opposing natural antagonistic tooth.\n* Active periodontal disease.\n* major active systemic disease affecting soft tissue healing\n* Multiple implant supported restorations already present.\n* Long edentulous spaces.\n* Complete edentulous cases'}, 'identificationModule': {'nctId': 'NCT07196293', 'briefTitle': 'A Comparison Between Protemp and Flowable Light Cure Composite Material for Creating Optimal Gingival Emergence Profile Around Implant', 'organization': {'class': 'OTHER', 'fullName': 'Amrita Institute of Medical Sciences & Research Center'}, 'officialTitle': 'A Comparison Between Protemp and Flowable Light Cure Composite Material for Creating Optimal Gingival Emergence Profile and Evaluation of Peri-implant Soft Tissue; an In-vivo Study', 'orgStudyIdInfo': {'id': 'ECASM-AIMS-2023-356'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'standard titanium healing abutment', 'description': 'standard titanium healing abutments used'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'customized healing abutment - bulk-fill flowable composite', 'interventionNames': ['Procedure: Customized Healing Abutment - bulk fill composite']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'customized healing abutment - Protemp 4 (Bis-Acryl composite)', 'interventionNames': ['Procedure: customized healing abutments - Bis acryl composite materials']}], 'interventions': [{'name': 'Customized Healing Abutment - bulk fill composite', 'type': 'PROCEDURE', 'description': 'instead of standard healing abutments , customization was done using bulk fill composite', 'armGroupLabels': ['customized healing abutment - bulk-fill flowable composite']}, {'name': 'customized healing abutments - Bis acryl composite materials', 'type': 'PROCEDURE', 'description': 'customized healing abutments with bis acryl composite material was used instead of standard healing abutments', 'armGroupLabels': ['customized healing abutment - Protemp 4 (Bis-Acryl composite)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '682041', 'city': 'Kochi', 'state': 'Kerala', 'country': 'India', 'facility': 'Amrita School Of Dentistry', 'geoPoint': {'lat': 9.93988, 'lon': 76.26022}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amrita Institute of Medical Sciences & Research Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Bhavin Milind Patil', 'investigatorAffiliation': 'Amrita Institute of Medical Sciences & Research Center'}}}}