Ignite Creation Date:
2025-12-24 @ 5:51 PM
Ignite Modification Date:
2026-01-07 @ 1:05 PM
Study NCT ID:
NCT06558968
Status:
RECRUITING
Last Update Posted:
2024-08-19
First Post:
2021-08-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of PEEK and BruxZir as Esthetic Space Maintainers in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER'], 'maskingDescription': 'articipants will be blinded to the type of intervention. Teeth treated will be assigned codes so that outcome evaluators at the follow up appointments are blinded. On the other hand, the operator/ primary investigator cannot be blinded, as she is already familiar with the nature of the materials used. For statistical analysis, codes will also assure blinding and confidentiality. For the patient, both types of space maintainers will have the same color and design.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-16', 'studyFirstSubmitDate': '2021-08-30', 'studyFirstSubmitQcDate': '2024-08-16', 'lastUpdatePostDateStruct': {'date': '2024-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical performance', 'timeFrame': '1 year', 'description': 'regarding debonding or fracture of the appliance. if debonding or fracture occur then this means failure.'}, {'measure': 'Gingival health', 'timeFrame': '1 year', 'description': 'Gingival Index of Loe and Silness. where score 0 indicates normal gingiva, score 1 mild inflammation (slight change in color, slight edema but no bleeding on probing. score 2 indicates moderate inflammation (redness, edema, bleeding on probing and score 3 refers to severe inflammation (marked redness, edema, ulceration with sponatnoeus bleeding.'}], 'secondaryOutcomes': [{'measure': 'Wear of the opposing tooth', 'timeFrame': '1 year', 'description': 'using CAD/CAM software Cerec software (Cerec 4.2, DentsplySirona, Bensheim, Germany)volumetric loss on the surfaces were calculated in the last follow up visit after 1 year'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pediatric Dentistry']}, 'descriptionModule': {'briefSummary': 'Compare two band and loop space maintainers made from two tooth colored materials; Polyetherethherketone (PEEK) and monolithic Zirconia (BruxZir) as regards to:\n\n* Clinical performance of space maintainers in terms of frequency of debonding or fracture of the appliance and health of adjacent gingiva during a one-year follow up.\n* Wear of the opposing teeth.', 'detailedDescription': "After extraction of the mandibular first primary molars in both mandibular quadrants, impressions will be taken with intraoral scanner. Then, it will be sent to the CAD/CAM laboratory to construct functional band and loop space maintainers using PEEK and monolithic zirconia 'BruxZir' blocks with proper shades.\n\nAfter the fabrication of the space maintainers of both sides, they will be cemented with resin luting cement containing MDP monomer. Photographs will be taken after cementation for the space maintainers and the patient will be informed and educated about the oral hygiene measures. The parents will also be inquired to call if any discomfort, debonding or fracture of the appliances happens."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Clinical inclusion criteria:\n\n * Children requiring bilateral extraction of mandibular first primary molars or those with previously extracted molars no more than 6 months prior to intervention (11) .\n * Existence of teeth on the mesial and distal side of edentulous area.\n * Angle's Class I molar relationship and/or flush terminal/mesial step primary molar occlusion\n\nRadiographic inclusion criteria:\n\n* No periapical and/ or furcural pathological condition related to abutment teeth.\n* Presence of tooth germ of the succeeding tooth (mandibular first premolars).\n* Presence of more than 1 mm of bone overlying the successor tooth germ\n\nExclusion Criteria:\n\n* Carious abutment teeth requiring pulp therapy.\n\n * Carious abutment primary teeth requiring a full coverage restoration.\n * Patients with history of bruxism or/and clenching.\n * Patients with medical, intellectual or physical disabilities.\n * Patients with abnormalities as posterior cross-bite, open bite, and deep bite"}, 'identificationModule': {'nctId': 'NCT06558968', 'briefTitle': 'Evaluation of PEEK and BruxZir as Esthetic Space Maintainers in Children', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Evaluation of Polyetheretherketone and Monolithic Zirconia as Esthetic Functional Space Maintainers in Children (A Randomized Clinical Trial)', 'orgStudyIdInfo': {'id': 'PED21-8D'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'polyetheretherketone', 'description': "PEEK 'Polyetheretherketone' Victrex® is a type of polymer with suitable mechanical and\n\nphysical properties. It is a resilient material with high flexural strength and resistance\n\nto deformation. Therefore, it can be used in fixed prosthesis and space maintainers", 'interventionNames': ['Other: aesthetic functional space maintainers']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'monolithic zirconia', 'description': 'BruxZir® is a type of monolithic zirconia with higher flexural strength and fracture toughness than the classic zirconia and can withstand the changes in temperature in the oral cavity. Therefore it can be used as a space maintainer', 'interventionNames': ['Other: aesthetic functional space maintainers']}], 'interventions': [{'name': 'aesthetic functional space maintainers', 'type': 'OTHER', 'description': "evaluate the use of Polyetheretherketone 'PEEK' and monolithic zirconia 'Bruxzir' as esthetic functional band and loop space maintainers.", 'armGroupLabels': ['monolithic zirconia', 'polyetheretherketone']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'facility': 'Ain Shams University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Hagar Abozeid, PhD', 'role': 'CONTACT', 'email': 'Hagar_abozeid_22@hotmail.com', 'phone': '0201110611169'}, {'name': 'Mariem Wassel, Professor', 'role': 'CONTACT', 'phone': '01064871416'}], 'overallOfficials': [{'name': 'Nagwa Khattab, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ainshams U'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Hagar Abozeid', 'investigatorAffiliation': 'Ain Shams University'}}}}