Clínica Universitaria de Odontologia
Sant Cugat del Vallès, Barcelona, 08195, Spain
Location status: Recruiting
NCT Number: NCT06364982
The aim of this study is to analyse contiguous dental implants and its peri-implant status depending on different inter-implant distances.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Sant Cugat del Vallès, Barcelona, 08195, Spain
Location status: Recruiting
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:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: At least 36 months of function - at the moment of the evaluation
Prevalence of peri-implant mucositis and peri-implantitis.
Time frame: At least 36 months of function - at the moment of the evaluation
Full Mouth Plaque Index
Time frame: At least 36 months of function - at the moment of the evaluation
Full Mouth Bleeding Index
Time frame: At least 36 months of function - at the moment of the evaluation
modified Plaque Index
Time frame: At least 36 months of function - at the moment of the evaluation
modified Bleeding Index
Time frame: At least 36 months of function - at the moment of the evaluation
Suppuration on Probing
Time frame: At least 36 months of function - at the moment of the evaluation
Probing Pocket Depth
Time frame: At least 36 months of function - at the moment of the evaluation
Mucosal Recession
Time frame: At least 36 months of function - at the moment of the evaluation
Keratinized Mucosa
Time frame: At least 36 months of function - at the moment of the evaluation
Implant location in the oral cavity
Time frame: At least 36 months of function - at the moment of the evaluation
Implant position in the oral cavity
Time frame: At least 36 months of function - at the moment of the evaluation
Implant type used
Time frame: At least 36 months of function - at the moment of the evaluation
Brand of the implant used
Time frame: At least 36 months of function - at the moment of the evaluation
Type of implant roughness
Time frame: At least 36 months of function - at the moment of the evaluation
Type of implant diameter
Time frame: At least 36 months of function - at the moment of the evaluation
Length of the implant
Time frame: At least 36 months of function - at the moment of the evaluation
Apico-coroal position
Time frame: At least 36 months of function - at the moment of the evaluation
Inter-implant distance
Time frame: At least 36 months of function - at the moment of the evaluation
Moment of the implant placement
Time frame: At least 36 months of function - at the moment of the evaluation
Bone grafting associated with the implant placement
Time frame: At least 36 months of function - at the moment of the evaluation
Screwed or Cemented
Time frame: At least 36 months of function - at the moment of the evaluation
Cleansable, difficult or impossible to clean
Contact information is provided by the study sponsor or research team.
Ioannis Terpou, MSc
CONTACT
Tiago R Amaral, MSc
CONTACT
Universitat Internacional de Catalunya
Other
Distance Between Dental Implants as a Risk Indicator for Peri-implant Disease. A Multi-center Cross-sectional Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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