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This study aims to assess the treatment outcomes (clinical, functional and subjective) of full arch rehabilitations supported by implants with or without an immediate loading protocol. In this randomized clinical trial 20 fully edentulous patients were treated with full arch rehabilitations on dental implants. In half of the sample, the implants were loaded immediately by means of abutments after emplacement of the implant; but in the counterparts these abutments were connected to implants two months after the surgery (conventional protocol), and until that time the dentures were retained by healing abutments. Treatment outcomes were assessed at 2, 6 and 12 months after surgery. Clinical outcomes were quantified on the basis of implant failure rate, marginal bone loss and the peri-implant gingival index. Functional outcomes were calculated according to masticatory performance, estimated by the mixed fraction of a two-coloured chewing gum after 5, 10 and 15 chewing strokes, by the occlusal force recorded by pressure-sensitive sheets and by the bioelectrical muscular activity. The subjective outcomes of the treatment were assessed using both the oral satisfaction scale (visual analogue scale) and the Spanish version of the Oral Health Impact Profile (OHIP-20).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional Loading | Active Comparator | implants are loaded at least after two months of healing |
|
| Immediate Loading | Experimental | implants are loaded the same day of surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implant supported dentures | Procedure | Placement of dental implants with different loading protocols for supporting full arch dentures. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Performance of Dental implants | Implant failure rate | One year after treatment |
| Oral health-related quality of life | impact according to the OHIP-20 (Oral Health Impact Profile) instrument. The score range from 0 to 20, being 20 the worst outcome. | One year after treatment |
| Mastication | Mixing ability tests | One year after treatment |
| Area of Occlusal Occlusion | According to pressure-sensitive colorimetric sheets it is recorded the area in square millimeters | One year after treatment |
| Occlusal Load | According to the pressure-sensitive colorimetric sheets , the load in both the anterior and posterior region of the arch are calculated. | One year after treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinica Odontológica de la Universidad de Salamanca | Salamanca | 37007 | Spain |
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| ID | Term |
|---|---|
| D007575 | Jaw, Edentulous |
| D000848 | Anodontia |
| ID | Term |
|---|---|
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D009057 | Stomatognathic Diseases |
| D009066 | Mouth, Edentulous |
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| ID | Term |
|---|---|
| D019094 | Dental Prosthesis, Implant-Supported |
| ID | Term |
|---|---|
| D017266 | Dental Prosthesis |
| D011476 | Prosthodontics |
| D003813 | Dentistry |
| D019736 | Prostheses and Implants |
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| D009059 |
| Mouth Diseases |
| D014076 | Tooth Diseases |
| D014071 | Tooth Abnormalities |
| D018640 | Stomatognathic System Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D004864 |
| Equipment and Supplies |