An observational study in Peri-implant Mucositis and Peri-Implantitis, sponsored by Universitat Internacional de Catalunya. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-17.
Sponsored by Universitat Internacional de Catalunya · Observational
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:
488 studies on the registry are indexed under Mucositis; 70 are open to participants now.
This study's planned enrollment of 180 is above the median of 102 across 66 observational studies indexed under Mucositis.
Browse Mucositis studies →Universitat Internacional de Catalunya is the lead sponsor of 144 studies on the registry; 43 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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).
Exclusion Criteria:
Presence of an inter-implant distance ≤ 3mm
Diagnostic Test: Two contiguous dental implants placed with less ≤ 3mm from each other.
Presence of an inter-implant distance ≥ 3mm
Diagnostic Test: Two contiguous dental implants placed with > 3mm from each other.
Implant Placement of 2 contiguous dental implants with less ≤ 3mm from each other.
Implant Placement of 2 contiguous dental implants with \> 3mm from each other.
Prevalence of peri-implant diseases.
Prevalence of peri-implant mucositis and peri-implantitis.
Time frame: At least 36 months of function - at the moment of the evaluation
FMPI
Full Mouth Plaque Index
Time frame: At least 36 months of function - at the moment of the evaluation
FMBI
Full Mouth Bleeding Index
Time frame: At least 36 months of function - at the moment of the evaluation
mPI
modified Plaque Index
Time frame: At least 36 months of function - at the moment of the evaluation
mBI
modified Bleeding Index
Time frame: At least 36 months of function - at the moment of the evaluation
SoP
Suppuration on Probing
Time frame: At least 36 months of function - at the moment of the evaluation
PPD
Probing Pocket Depth
Time frame: At least 36 months of function - at the moment of the evaluation
MR
Mucosal Recession
Time frame: At least 36 months of function - at the moment of the evaluation
KM
Keratinized Mucosa
Time frame: At least 36 months of function - at the moment of the evaluation
Implant location
Implant location in the oral cavity
Time frame: At least 36 months of function - at the moment of the evaluation
Implant position
Implant position in the oral cavity
Time frame: At least 36 months of function - at the moment of the evaluation
Implant type
Implant type used
Time frame: At least 36 months of function - at the moment of the evaluation
Implant brand
Brand of the implant used
Time frame: At least 36 months of function - at the moment of the evaluation
Implant roughness
Type of implant roughness
Time frame: At least 36 months of function - at the moment of the evaluation
Implant diameter
Type of implant diameter
Time frame: At least 36 months of function - at the moment of the evaluation
Implant length
Length of the implant
Time frame: At least 36 months of function - at the moment of the evaluation
Apico-coronal position of the implant
Apico-coroal position
Time frame: At least 36 months of function - at the moment of the evaluation
Inter-implant distances (IID)
Inter-implant distance
Time frame: At least 36 months of function - at the moment of the evaluation
Implant placement protocol
Moment of the implant placement
Time frame: 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
Time frame: At least 36 months of function - at the moment of the evaluation
Implant-supported restorations
Screwed or Cemented
Time frame: At least 36 months of function - at the moment of the evaluation
Cleansability of the prosthesis
Cleansable, difficult or impossible to clean
Time frame: At least 36 months of function - at the moment of the evaluation
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Universitat Internacional de Catalunya