Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Dental implants are worldwide recognized one of the best manners to replace lost or hopeless prognosis teeth. There are different variables that creates proper conditions for long-term prognosis of implant treatments.
Implant position and surrounding bone around them, have been described in scientific literature to be key factors in the longevity of those treatments.
It has to be defined the "critical bone thickness" around implants. It basically means that implants has to be completely surrounded by bone, that will serve as protection. If the implants are not surrounded by bone, procedures as guided bone regeneration may be performed.
Those procedures can be executed before or simultaneously during the implant placement. In the standard procedure, the simultaneous guided bone regeneration during implant placement requires to leave the implant and the regeneration healing below the gingiva, needing a second surgery for accesing to those implants.
In this randomized controlled trial the hypothesis is to discover if not submerging this regenerations may show the same results than submerged ones.
For that, the objective is to study the different variables around these regeneration to evaluate the performance of non-submerged protocol.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group (Submerged Approach) | Active Comparator | Standard/Conventional approach in which guided bone regeneration simultaneous to implant placement is leaved submerged under gingival tissue by suturing looking for first intention healing. |
|
| Test Group (Non-Submerged Approach) | Experimental | To test approach in which guided bone regeneration simultaneous to implant placement is leaved in a non-submerged manner with second intention healing around an abutment and interproximal suturing. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Guided Bone Regeneration (Submerged) | Procedure | Guided Bone Regeneration by means of bone xenograft and collagen membrane (submerged approach) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Vertical bone dimensional changes | Comparison between CBCT images. Vertical bone changes in mm from initial CBCT to 12 months CBCT will be asessed. | 0-12months |
| Measure | Description | Time Frame |
|---|---|---|
| Horizontal bone dimensional changes | Comparison between CBCT images | 0-12 months |
| Buccal Bone thickness (Dehiscence resolution) | Comparison between CBCT images |
Not provided
Inclusion Criteria:
• Men and women over 18 years old.
Exclusion Criteria:
Implant surgery requiring sinus lift procedure.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Germán Pardo Perl, DDS, MSc | Contact | +34630083315 | Germanpardo@uic.es |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Uic Barcelona | Barcelona | Spain |
|
Not provided
Not provided
Not provided
Not provided
Not provided
| Guided Bone Regeneration (Non-submerged) | Procedure | Guided Bone Regeneration by means of bone xenograft and collagen membrane (Non submerged Approach) |
|
| 0-12 months |
| Marginal Bone Loss (MBL) | Comparison between 2d xrays | 0-12 months |
| Peri-implant clinical parameters | Clinical variables | 0-12 months |
| Volumetric parameters | Comparison between STL's models | 0-12 months |
| PROMs | Patient Related Outcomes. (Overall satisfaction from 1-10, Pain perceived from 1-10, Willingness to repeat in case of need from 1-10) | 0-12 months |