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| Name | Class |
|---|---|
| Camlog Oral Reconstruction Foundation | OTHER |
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Introduction: the repeated connection and disconnection of healing abutments during dental implants´ osseointegration has been associated with significant increased peri-implant bone loss, when compared with placing the final prosthetic abutment during implant placement surgery and non-removing it ever again. Previous data from animal studies suggests that the higher the number of removals of the healing abutments, the greater the bone resorption around implants, however the evidence in humans is scarce and heterogeneous. Furthermore, this greater bone resorption has been claimed to be associated to the inflammatory status of the peri-implant soft tissues, which would be greater as a consequence of the repeated disruption of the soft-tissues attachment to the prosthetic abutment, and the hypothetical microbial contamination of the implant-abutment interphase, induced by the repeated manipulation of the prosthetic components.
Objective: to evaluate the changes in peri-implant crestal bone levels between two prosthetic protocols, the control being the conventional protocol where healing abutments are placed during surgery and removed four times before the delivery of the final abutment and prostheses, and the test protocol where definitive abutments are placed immediately after implant placement and are not removed ever again.
Material and methods: 80 platform switched implants will be placed in the posterior maxilla or mandible of 40 partial edentulous patients. Immediately after implant placement, patients will be randomized to receive the definitive abutment at the moment of implant placement (one abutment-one time protocol), or 12 weeks later, after removing the healing abutment four times during the confection of the final prostheses, following the conventional protocol for implant supported restorations. The day of prostheses delivery, a mucosal biopsy from the implant surrounding tissues will be taken for histomorphometric and immunohistochemical analyses of the inflammatory response of the peri-implant soft tissues. Radiographic assessment of vertical bone level changes (primary outcome), clinical status of peri-implant tissues, changes in soft tissues margin, patient related outcomes and adverse events will be assessed at 6, 12, 24 and 36 months after loading.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Definitive abutment | Experimental | Definitive prosthetic abutment placed at the moment of implant placement |
|
| Healing abutment | Active Comparator | Conventional healing abutment placed at the moment of implant placement and removed 4 times during prosthesis making |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abutment removal | Procedure | 4 times healing abutment removal during prosthesis making (impressions, metal try-in, ceramic try-in, prosthesis loading) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in interproximal bone levels | Changes at the mesial and distal crestal bone levels measured in periapical digital radiographs at the mesial and distal implant aspects | Implantation, prosthesis loading, 6 months, 12 months, 24 months, 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mobility | Implant and/or prostheses mobility | Prosthesis loading, 6 months, 12 months, 24 months, 36 months |
| Keratinized peri-implant mucosa | Presence or absence of keratinized peri-implant mucosa in the mid-buccal and mid-lingual aspects |
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Inclusion Criteria:
Exclusion Criteria:
Systemic exclusion criteria:
Local exclusion criteria:
Exclusion criteria at surgery: in any of the following circumstances, the patient will not be randomized and will be excluded from the analysis
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| Name | Affiliation | Role |
|---|---|---|
| Mariano Sanz, Prof. Dr. | University Complutense of Madrid | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dental School, University Complutense of Madrid | Madrid | 28040 | Spain |
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| Placement of definitive abutment | Procedure | Placement of the final prosthetic abutment at the moment of implantation |
|
| Prosthesis loading, 6 months, 12 months, 24 months, 36 months |
| Modified plaque index | Modified plaque index (Mombelli et al. 1987) at six sites per implant | Prosthesis loading, 6 months, 12 months, 24 months, 36 months |
| Sulcus bleeding index | Sulcus bleeding index (Mombelli et al. 1987) at six sites per implant | Prosthesis loading, 6 months, 12 months, 24 months, 36 months |
| Probing depth | Probing depth (Mombelli et al. 1987) at six sites per implant | Prosthesis loading, 6 months, 12 months, 24 months, 36 months |
| Clinical crown length of the adjacent tooth | CLT: distance in mm from the highest line of gingival/mucosal curvature of the crown to the occlusal aspect of the tooth | Prosthesis loading, 6 months, 12 months, 24 months, 36 months |
| Clinical crown length of the implant supported crown | CLI: distance in mm from the highest line of mucosal curvature of the crown to the occlusal aspect of the implant prostheses | Prosthesis loading, 6 months, 12 months, 24 months, 36 months |
| Papilla index | IP: distance in mm from the top of the mesial and distal papillae of each implant to the most coronal portion of the contact point or the occlusal surface (Grunder 2000) | Prosthesis loading, 6 months, 12 months, 24 months, 36 months |
| Patient-reported outcomes | 5-items questionnaire (comfort, appearance, masticatory function, taste and overall satisfaction) rated according to the following scale: very unsatisfied, unsatisfied, fair, satisfied, and very satisfied | Prosthesis loading, 6 months, 12 months, 24 months, 36 months |
| Adverse events | Occurrence and nature of adverse events, either "implant or prostheses associated" (device related adverse events and other tissue complications), or "non-implant associated" (death, serious illness or any condition requiring hospitalization for more than 1 day). | Prosthesis loading, 6 months, 12 months, 24 months, 36 months |
| Hystomorphometric analysis of soft tissue biopsy samples | Total areas of the sample, the epithelium, the connective tissue, the inflammatory infiltrate and cell density in an interest area into the inflammatory infiltrate | Prosthesis loading |
| Immunohistochemical analysis of the histologic sections | Nature and extension of the inflammatory infiltrate in the connective tissue: high positive (HP), positive (P), low positive (LP) or negative (N) staining | Prosthesis loading |