Ignite Creation Date:
2025-12-24 @ 10:41 PM
Ignite Modification Date:
2025-12-25 @ 8:11 PM
Study NCT ID:
NCT06281535
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-28
First Post:
2024-02-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Early Versus Conventional Loading for Fully Guided Immediate Implant Placement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D057893', 'term': 'Immediate Dental Implant Loading'}], 'ancestors': [{'id': 'D003758', 'term': 'Dental Implantation, Endosseous'}, {'id': 'D003757', 'term': 'Dental Implantation'}, {'id': 'D013516', 'term': 'Oral Surgical Procedures, Preprosthetic'}, {'id': 'D019647', 'term': 'Oral Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019919', 'term': 'Prosthesis Implantation'}, {'id': 'D003813', 'term': 'Dentistry'}, {'id': 'D011476', 'term': 'Prosthodontics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-02-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-06-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-24', 'studyFirstSubmitDate': '2024-02-06', 'studyFirstSubmitQcDate': '2024-02-24', 'lastUpdatePostDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Implant stability', 'timeFrame': '2 and 3 months following implant placement', 'description': 'Degree of implant stability will be measured by Osstell device as a scale from 1 to 100'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['early loading', 'conventional loading'], 'conditions': ['Dental Implant']}, 'descriptionModule': {'briefSummary': 'Conventional loading protocol following implant placement 3 -6 months is considered the gold standard. However, early loading following 2 months after implant placement decreases the time and had a good survival rate.', 'detailedDescription': 'The conventional loading protocol presented involves healing period of 3 -6 months. A healing period without stress was recommended in the order to present better survival rate. This loading protocol was developed in the time when micro- and macro design of implant surface was machine produced. Early loading of dental implants within 2 months following placement on healed posterior mandible showed 100% survival rate for five years follow up, with uneventful crestal bone loss. The lack of difference between conventional loading 6 months following implant placement and early loading could be explained by the fact that even if the crowns were not put in direct occlusion, patients used them functionally when chewing. The most relevant factor which may explain the positive results obtained in this trial is the high insertion torque at implant placement.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients age range from 20-60 years.\n* Molar tooth to be extracted due to periodontal diseases, peri- apical diseases, Endo-perio diseases, or tooth fracture.\n* Primary implant stability is above 30 Ncm.\n\nExclusion Criteria:\n\n* History or presence of severe uncontrolled systemic disease.\n* Heavy smokers (\\>10 cigarettes per day) or alcohol/drug abusers.\n* Poor oral hygiene.\n* Acute periapical infection.'}, 'identificationModule': {'nctId': 'NCT06281535', 'briefTitle': 'Early Versus Conventional Loading for Fully Guided Immediate Implant Placement', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Early Versus Conventional Loading for Fully Guided Immediate Implant Placement in Molar Sites (A Randomized Controlled Clinical Study)', 'orgStudyIdInfo': {'id': '21789'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Early loading group', 'description': 'The surgical treatment protocol entails atraumatic tooth extraction, fixture insertion and placement of the final restoration 2 months following implant placement.', 'interventionNames': ['Device: Implant loading']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional loading group', 'description': 'The surgical treatment protocol entails atraumatic tooth extraction, fixture insertion and placement of the final restoration 3 months following implant placement.', 'interventionNames': ['Device: Implant loading']}], 'interventions': [{'name': 'Implant loading', 'type': 'DEVICE', 'description': 'Placement of abutments and final restorations either 2 months following implant placement in early loading group or 3 months in conventional loading group', 'armGroupLabels': ['Conventional loading group', 'Early loading group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Doaa Adel-Khattab, PhD', 'role': 'CONTACT', 'email': 'dr.doaa.adel-khattab@dent.asu.edu.eg', 'phone': '01006814258'}, {'name': 'Abdel Rahman Khalaf, PHD', 'role': 'CONTACT', 'email': 'abdodent84@yahoo.com', 'phone': '0116589954'}], 'overallOfficials': [{'name': 'Doaa Adel-Khattab, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Associate Professor Faculty of Dentistry, Ain Shams University'}, {'name': 'Abdel Rahman Khalaf, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lecturer of Faculty of Dentistry, Assiut University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Assiut University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Doaa Adel Salah Khattab', 'investigatorAffiliation': 'Ain Shams University'}}}}