Immediate Versus Conventional Loading of Early Placed Dental Implant Supporting Single Crowns
NCT ID: NCT06693297
Last Updated: 2024-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2024-09-25
2026-09-30
Brief Summary
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The aim of the randomized controlled trial is to compare between two loading protocols (immediate versus conventional) of early placed implants (Type 2-3A) in terms of clinical, radiographic, and patient-reported outcomes.
Null hypothesis: There will be no significant differences in implant survival/success, stability, radiographic marginal bone level, and patient reported outcomes between immediately or conventionally loaded and early placed implants.
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Detailed Description
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This study is designed as a parallel group randomized controlled trial with an allocation ratio of 1:1.
The (PICO) study design: population will be patients from Jordan University Hospital aged 18 years or older, requiring single tooth replacement (molar or premolar) with dental implants, with sufficient bone volume and controlled oral hygiene. The intervention group will receive immediate loading of early placed implants (within 1 week), while the comparator group will receive conventional loading (after more than 8 weeks). The primary outcome is changes in marginal bone levels, and the secondary outcomes include implant primary osseointegration, stability, patient satisfaction, and various complications.
Both groups will receive early placed implants after 8-12 weeks of healing (Type 2-3A placement). The surgical procedure will follow standardized protocols, with no variations between groups other than the loading time.
Blinded assessors will perform radiographic and clinical evaluations at designated follow-up visits: at implant placement, definitive loading, 6 months, and 1 year. Ethical approval is obtained prior to study commencement, and all participants will provide informed consent.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Conventional loading of early placed implants
Early placed implants ( within 16 weeks of healing after Extraction of a tooth) will be conventionally loaded ( at least 8 weeks after implant placement )
Immediate loading of early placed implants
Implants with active thread design will be used. The implants placed will be randomly allocated into either immediate loading or conventional loading group.
Conventional loading of early placed implants
Definitive loading of early placed implants upon successful osteointegration (after 8 weks)
Immediate loading of early placed implants
Early placed implants (within 16 weeks of tooth extraction) will be loaded immediately with provisional screw retained crown
Immediate loading of early placed implants
Implants with active thread design will be used. The implants placed will be randomly allocated into either immediate loading or conventional loading group.
Conventional loading of early placed implants
Definitive loading of early placed implants upon successful osteointegration (after 8 weks)
Interventions
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Immediate loading of early placed implants
Implants with active thread design will be used. The implants placed will be randomly allocated into either immediate loading or conventional loading group.
Conventional loading of early placed implants
Definitive loading of early placed implants upon successful osteointegration (after 8 weks)
Eligibility Criteria
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Inclusion Criteria
2. requiring single tooth replacement with dental implants in presence of four bone walls (mandible or maxilla)
3. having adequate bone volume
4. controlled oral hygiene
5. having agreed to take part in the study and willing to comply with the study protocol and follow-up visits
Exclusion Criteria
2. history of radiation therapy to the head and neck region
3. history of bisphosphonate therapy or other medications that may affect bone metabolism
4. smoking more than 10 cigarettes/day
5. history of bruxism or parafunctional habits
6. localized/generalized periodontitis
7. patients in need of bone grafting
8. any known allergy or hypersensitivity to implant materials
18 Years
ALL
Yes
Sponsors
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Straumann Group
UNKNOWN
MegaGen
UNKNOWN
University of Jordan
OTHER
Responsible Party
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Mohammad AL-Rababáh
Associate Professor
Locations
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Jordan University Hospital
Amman, , Jordan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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10/2024/22294
Identifier Type: -
Identifier Source: org_study_id
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