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The aim of this study is to analyse contiguous dental implants and its peri-implant status depending on different inter-implant distances.
The present research project has been designed as a multicentric cross-sectional study. The STROBE guidelines have been followed in the design of this observational study.
Ethical issues The study will be performed after the approval of the Ethics Committee of the Universitat Internacional de Catalunya (UIC) and Faculdade de Medicina Dentária da Universidade de Lisboa (FMDUL) and will be intended to be registered in clinicaltrials.gov. Also, this research will be conducted according to the principles outlined in the Declaration of Helsinki (revised, amended, and clarified in 2013). In addition, all study participants will provide written informed consent before participating in the study.
Study population Subjects will be selected from an electronic database collected at the CUO (UIC) / CU (FMDUL) and composed of patients treated with at least two contiguous dental implants before 2021. This investigation will use a stratified random sampling based on year of implant placement to select a representative sample of subjects with implant-supported restorations conducted during the period 2001-2020 at the CUO and CU. Then, two examiners (I.T. / F.F.) will contact patients by telephone once every 2 days (with a maximum of 3 attempts) for an evaluation by the same investigators (I.T / F.F).
Criteria for subject selection will be as follows:
Moreover, the exclusion criteria will be the following:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inter-implant distance ≤ 3mm | Presence of an inter-implant distance ≤ 3mm |
| |
| Inter-implant distance ≥ 3mm | Presence of an inter-implant distance ≥ 3mm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Two contiguous dental implants placed with less ≤ 3mm from each other. | Diagnostic Test | Implant Placement of 2 contiguous dental implants with less ≤ 3mm from each other. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of peri-implant diseases. | Prevalence of peri-implant mucositis and peri-implantitis. | At least 36 months of function - at the moment of the evaluation |
| Measure | Description | Time Frame |
|---|---|---|
| FMPI | Full Mouth Plaque Index | At least 36 months of function - at the moment of the evaluation |
| FMBI | Full Mouth Bleeding Index | At least 36 months of function - at the moment of the evaluation |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects will be selected from an electronic database collected at the CUO (UIC) / CU (FMDUL) and composed of patients treated with at least two contiguous dental implants before 2021. This investigation will use a stratified random sampling based on year of implant placement to select a representative sample of subjects with implant-supported restorations conducted during the period 2001-2020 at the CUO and CU. Then, two examiners (I.T. / F.F.) will contact patients by telephone once every 2 days (with a maximum of 3 attempts) for an evaluation by the same investigators (I.T / F.F).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ioannis Terpou, MSc | Contact | +306978218177 | ioannisterpou.95@uic.es | |
| Tiago R Amaral, MSc | Contact | +351916067069 | tiagoamaral@edu.ulisboa.pt |
| Name | Affiliation | Role |
|---|---|---|
| Cristina V Vallès, PhD | Department of Periodontology, University Internacional de Cataluña | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clínica Universitaria de Odontologia | Recruiting | Sant Cugat del Vallès | Barcelona | 08195 | Spain |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 10, 2024 |
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| Two contiguous dental implants placed with > 3mm from each other. | Diagnostic Test | Implant Placement of 2 contiguous dental implants with > 3mm from each other. |
|
| mPI | modified Plaque Index | At least 36 months of function - at the moment of the evaluation |
| mBI | modified Bleeding Index | At least 36 months of function - at the moment of the evaluation |
| SoP | Suppuration on Probing | At least 36 months of function - at the moment of the evaluation |
| PPD | Probing Pocket Depth | At least 36 months of function - at the moment of the evaluation |
| MR | Mucosal Recession | At least 36 months of function - at the moment of the evaluation |
| KM | Keratinized Mucosa | At least 36 months of function - at the moment of the evaluation |
| Implant location | Implant location in the oral cavity | At least 36 months of function - at the moment of the evaluation |
| Implant position | Implant position in the oral cavity | At least 36 months of function - at the moment of the evaluation |
| Implant type | Implant type used | At least 36 months of function - at the moment of the evaluation |
| Implant brand | Brand of the implant used | At least 36 months of function - at the moment of the evaluation |
| Implant roughness | Type of implant roughness | At least 36 months of function - at the moment of the evaluation |
| Implant diameter | Type of implant diameter | At least 36 months of function - at the moment of the evaluation |
| Implant length | Length of the implant | At least 36 months of function - at the moment of the evaluation |
| Apico-coronal position of the implant | Apico-coroal position | At least 36 months of function - at the moment of the evaluation |
| Inter-implant distances (IID) | Inter-implant distance | At least 36 months of function - at the moment of the evaluation |
| Implant placement protocol | Moment of the implant placement | At least 36 months of function - at the moment of the evaluation |
| Bone grafting procedures (BGP) at implant placement | Bone grafting associated with the implant placement | At least 36 months of function - at the moment of the evaluation |
| Implant-supported restorations | Screwed or Cemented | At least 36 months of function - at the moment of the evaluation |
| Cleansability of the prosthesis | Cleansable, difficult or impossible to clean | At least 36 months of function - at the moment of the evaluation |
| Apr 10, 2024 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D057873 | Peri-Implantitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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