Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Fundação de Amparo à Pesquisa do Estado de São Paulo | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The main objective of this prospective, controlled, and randomized clinical study is to evaluate the peri-implant bone loss of immediately loaded versus conventionally loaded implants with a single prosthesis. A split-mouth experimental design will be used, and the success rate of the installed implants will be determined. Twelve selected patients (corresponding to a minimum of 24 surgical implant sites) will receive endosseous Ti dental implants. The protocol for preparing the surgical sites will be based on the manufacturer's recommendations and bone density. Patients with an initial torque less than 30 N·cm and an implant stability quotient (ISQ) less than 60 will be excluded from the research. Envelopes, indicating which site is the test site, will be opened after the implants are installed. Transfer impressions of the implants receiving immediate loading will be produced so that temporary crowns can be made. Temporary crowns will be installed a maximum of 24 hours after the surgery, by using the torque recommended by the manufacturer. Appropriate occlusal adjustment will be made to ensure minimal contact at maximum intercuspation and absence of contacts during protrusive and lateral excursive movements of the jaw. At baseline (time of implant installation) and 3, 6, 9, and 12 months after implant installation, the following aspects will be evaluated: the initial torque at the moment of implant insertion, Osstell ISQ, pain in the implant when subjected to vertical and horizontal forces, clinical mobility of the implant, crestal bone loss around the implant (as determined by x-ray evaluation), probing depth around the implant, and periodontal pain.
The main objective of this prospective, controlled, and randomized clinical study is to evaluate the peri-implant bone loss of immediately loaded versus conventionally loaded implants with a single prosthesis. A split-mouth experimental design will be used, and the success rate of the installed implants will be determined. Twelve selected patients (corresponding to a minimum of 24 surgical implant sites) will receive endosseous Ti dental implants. The protocol for preparing the surgical sites will be based on the manufacturer's recommendations and bone density. Patients with an initial torque less than 30 N·cm and an implant stability quotient (ISQ) less than 60 will be excluded from the research. Envelopes, indicating which site is the test site, will be opened after the implants are installed. Transfer impressions of the implants receiving immediate loading will be produced so that temporary crowns can be made. Temporary crowns will be installed a maximum of 24 hours after the surgery, by using the torque recommended by the manufacturer. Appropriate occlusal adjustment will be made to ensure minimal contact at maximum intercuspation and absence of contacts during protrusive and lateral excursive movements of the jaw. At baseline (time of implant installation) and 3, 6, 9, and 12 months after implant installation, the following aspects will be evaluated: the initial torque at the moment of implant insertion, Osstell ISQ, pain in the implant when subjected to vertical and horizontal forces, clinical mobility of the implant, crestal bone loss around the implant (as determined by x-ray evaluation), probing depth around the implant, and periodontal pain. These data will be collected for both the control/delayed loading group and the test/immediate loading group, followed by statistical analysis
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| immediate implant surgery | Experimental | Immediate implant surgery in one site. |
|
| conventional implant surgery | Active Comparator | Conventional implant surgery in another site |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| immediate implant surgery | Procedure | Surgery of dental implants in one side of the mouth. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bone Loss of Immediate Versus Conventional Implants as determined by x-ray evaluation | The same bone loss of for conventional and immediate implants. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| The success rate of the installed implants will be determined | Survival rate must be the same for the immediate and conventional implants | 12 months |
Not provided
Inclusion Criteria: edentulous sites bilateral in maxilla and mandibula with adequate quantity of bone
Exclusion Criteria: Patients with an initial torque less than 30 N·cm and an implant stability quotient (ISQ) less than 60 will be excluded from the research
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mônica N. Pigozzo, PhD | University of Sao Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mônica Nogueira Pigozzo | São Paulo | 04726-010 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24383987 | Background | Galindo-Moreno P, Leon-Cano A, Ortega-Oller I, Monje A, O Valle F, Catena A. Marginal bone loss as success criterion in implant dentistry: beyond 2 mm. Clin Oral Implants Res. 2015 Apr;26(4):e28-e34. doi: 10.1111/clr.12324. Epub 2014 Jan 3. | |
| 22866288 | Background | Cannizzaro G, Felice P, Leone M, Ferri V, Viola P, Esposito M. Immediate versus early loading of 6.5 mm-long flapless-placed single implants: a 4-year after loading report of a split-mouth randomised controlled trial. Eur J Oral Implantol. 2012 Summer;5(2):111-21. |
| Label | URL |
|---|---|
| Galindo-Moreno P, León-Cano A, Ortega-Oller I, Monje A, O Valle F, Catena A. Marginal bone loss as success criterion in implant dentistry: beyond 2 mm. | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D016301 | Alveolar Bone Loss |
| ID | Term |
|---|---|
| D001862 | Bone Resorption |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D055093 | Periodontal Atrophy |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| implant surgery (Straumann®) | Device | Dental implant surgery in one of the sides of the mouth |
|
|
| D010510 |
| Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |