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| Name | Class |
|---|---|
| Mozo Grau Ticare Implants | UNKNOWN |
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The objective of this study is to evaluate the radiographic changes on the marginal peri-implant bone level on bone level implants with a narrower transmucosal abutment, in comparison to the conventional abutment, both of 3mm height
Patients will receive from one to eight bone-level implants according to their rehabilitation necessity and transmucosal abutments will be connected the day of the surgery. The control group will receive conventional transmucosal abutments while the test group will receive TCP abutments, with a narrower design.
Results will be evaluated initially 6 and 12 months after the connection of the definitive prostheses, and finally 3 years later.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Other | Control group will receive an intermediate transmucosal abutment with conventional diameter and 3mm height, once the implants are placed. |
|
| Test Group | Experimental | Test group will receive an intermediate transmucosal abutment with a TCP design, narrower than the conventional one, of 3mm height, once the implants are placed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional transmucosal abutment design | Device | The macroscopic design of the intermediate transmucosal abutment will be evaluated on terms of the marginal peri-implant bone levels using two identical devices, if only being the test device narrower than the control one |
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic marginal periimplant bone level changes | Measured as the distance from the bone crest to the first implant-to-bone contact. This will be assessed on parallelized periapical radiographies | from baseline (connection of the definitive abutment) to 6 and 12 months after the definitive prostheses will be connected, and finally 3 years later |
| Measure | Description | Time Frame |
|---|---|---|
| Probing pocket depth | measured with a CP12 probe as the distance from the soft tissue margin to the bottom of the peri-implant pocket | 6 and 12 months after the definitive prostheses will be connected, and finally 3 years later |
| Papilla refill |
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Inclusion Criteria:
Exclusion Criteria:
Systemic factors:
Local factors:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lucia Maceiras | Contact | +0034676780483 | luciamaceiraspombo@outlook.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Santiago de Compostela | Recruiting | Santiago de Compostela | La Coruña | 15782 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24735458 | Background | Alves CC, Munoz F, Cantalapiedra A, Ramos I, Neves M, Blanco J. Marginal bone and soft tissue behavior following platform switching abutment connection/disconnection--a dog model study. Clin Oral Implants Res. 2015 Sep;26(9):983-91. doi: 10.1111/clr.12385. Epub 2014 Apr 16. | |
| 8915028 | Background | Berglundh T, Lindhe J. Dimension of the periimplant mucosa. Biological width revisited. J Clin Periodontol. 1996 Oct;23(10):971-3. doi: 10.1111/j.1600-051x.1996.tb00520.x. |
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For each participant on the test group will be another participant on the control group
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None of the participants or the outcomes assessor will know the device (transmucosal abutment) received. The care provider will connect the transmucosal abutment while the surgery, after opening the randomization envelope; and the investigator will identify the participant's group while analysing the radiographs.
| Narrow transmucosal abutment design | Device | The macroscopic design of the intermediate transmucosal abutment will be evaluated on terms of the marginal peri-implant bone levels using two identical devices, if only being the test device narrower than the control one |
|
Evaluated according to the Jemt 1997 index
| 6 and 12 months after the definitive prostheses will be connected, and finally 3 years later |
| Bleeding on probing | Evaluated according to the Mombelli 1987 index, presence of bleeding after probing | 6 and 12 months after the definitive prostheses will be connected, and finally 3 years later |
| Plaque index | Evaluated according to the Mombelli 1987 index, presence of plaque | 6 and 12 months after the definitive prostheses will be connected, and finally 3 years later |
| Patient Reported Outcomes Measurements | Using a visual analoge scale from 1 to 10 to evaluate patient's satisfaction parameters related to the aesthetics, masticatory ability, confort, general satisfaction and phonetics | 6 and 12 months after the definitive prostheses will be connected, and finally 3 years later |
| Adverse effects frequency | Presence of adverse effects during the follow-up, such as fracture of the implant or the prosthetic unit or presence of periimplantitis or mucositis | 6 and 12 months after the definitive prostheses will be connected, and finally 3 years later |
| 29222809 | Background | Blanco J, Pico A, Caneiro L, Novoa L, Batalla P, Martin-Lancharro P. Effect of abutment height on interproximal implant bone level in the early healing: A randomized clinical trial. Clin Oral Implants Res. 2018 Jan;29(1):108-117. doi: 10.1111/clr.13108. Epub 2017 Dec 8. |
| 7790533 | Background | Ericsson I, Persson LG, Berglundh T, Marinello CP, Lindhe J, Klinge B. Different types of inflammatory reactions in peri-implant soft tissues. J Clin Periodontol. 1995 Mar;22(3):255-61. doi: 10.1111/j.1600-051x.1995.tb00143.x. |
| 31180160 | Background | Koutouzis T, Adeinat B, Ali A. The influence of abutment macro-design on clinical and radiographic peri-implant tissue changes for guided, placed, and restored implants: A 1-year randomized controlled trial. Clin Oral Implants Res. 2019 Sep;30(9):882-891. doi: 10.1111/clr.13493. Epub 2019 Jun 24. |
| 28817138 | Background | Novoa L, Batalla P, Caneiro L, Pico A, Linares A, Blanco J. Influence of Abutment Height on Maintenance of Peri-implant Crestal Bone at Bone-Level Implants: A 3-Year Follow-up Study. Int J Periodontics Restorative Dent. 2017 Sep/Oct;37(5):721-727. doi: 10.11607/prd.2762. |
| 30246409 | Background | Souza AB, Alshihri A, Kammerer PW, Araujo MG, Gallucci GO. Histological and micro-CT analysis of peri-implant soft and hard tissue healing on implants with different healing abutments configurations. Clin Oral Implants Res. 2018 Oct;29(10):1007-1015. doi: 10.1111/clr.13367. Epub 2018 Sep 23. |