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This will be a prospective, randomized, controlled, single center clinical trial with
1 year enrollment period, surgical and prosthetic rehabilitation with 1-year post-loading follow-up. A total of 2.0 years of study duration The primary objective is to compare peri-implant hard and soft tissue changes between single implants placed in the posterior mandible and immediately loaded either with definitive (one-time) or provisional abutment.
Hard tissue contour changes will be assessed using standardized two-dimensional intra-oral radiographs and partial small field of view three-dimensional cone beam CT scans. Soft tissue contour changes will be assessed using superimposition of dental digital models. Inflammatory soft tissue reactions will be evaluated by measurement of respective cytokines' levels.A quantitative evaluation of total bacteria amount of the peri-implant samples.
Secondary objectives of this study will be to estimate total bacterial amount (quantitative real-time polymerase chain reaction - qRT-PCR).
Bleeding on probing (BoP), full mouth oral hygiene index, periodontal pocket depth (PPD) and keratinized tissue width will also be evaluated.
Indication: Patients with need of at least two implants (one per side) in the premolar or molar region in the mandible, bilaterally.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| immediate loading | Other | Immediate loading of implants by means of one definitive abutment on one side and temporary abutment on the other side of the posterior mandible restored by provisional crown-split mouth design |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| immediate loading of implants | Other | This is a randomized control clinical trial including 24 implants, immediately loaded with definitive abutment protocol and 24 implants immediately loaded with with temporary abutment protocol |
| Measure | Description | Time Frame |
|---|---|---|
| Periimplant marginal bone loss | Hard tissue changes will be analyzed and followed up at 3, 6 and 12 months by captured intraoral radiographs using a customized radiographic holder. The following landmarks will be measured in order to assess bone remodelling around implants
| 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ana R Todorovic, DDS,PhD | School of Dentistry, University of Belgrade | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Dental Medicine University of Belgrade | Belgrade | 11000 | Serbia |
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