Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06364982
Status:
RECRUITING
Last Update Posted:
2024-04-15
First Post:
2024-01-31
Brief Title:
Distance Between Dental Implants as a Risk Indicator for Peri-implant Disease
Sponsor:
Universitat Internacional de Catalunya
Organization:
Universitat Internacional de Catalunya
Study Overview
Official Title:
Distance Between Dental Implants as a Risk Indicator for Peri-implant Disease A Multi-center Cross-sectional Study
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study is to analyse contiguous dental implants and its peri-implant status depending on different inter-implant distances
Detailed Description:
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 clinicaltrialsgov 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 IT FF will contact patients by telephone once every 2 days with a maximum of 3 attempts for an evaluation by the same investigators IT FF
Criteria for subject selection will be as follows
The patient must be 18 years of age and systemically healthy
Partially edentulous patients rehabilitated until 2020 ie a minimum of 3 years of function time with at least two contiguous implant-supported restorations in the maxilla or mandible
Screw or cemented-retained prosthesis
Fixed dental prosthesis ie single crowns and partial prosthesis
No implant mobility
Moreover the exclusion criteria will be the following
Pregnant and lactating women
Patients who have taken systemic antibiotics during the 3 months prior to the examination
Patients being treated with drugs that may induce a gingival overgrowth
Patients undergoing orthodontic treatment since it can influence periodontal diagnosis
Patients who have received mechanical debridement during the 3 months prior to the exam
Patients who have received surgical treatment for peri-implantitis
Psychophysical inability to carry out study procedures
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 clinicaltrialsgov 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 IT FF will contact patients by telephone once every 2 days with a maximum of 3 attempts for an evaluation by the same investigators IT FF
Criteria for subject selection will be as follows
The patient must be 18 years of age and systemically healthy
Partially edentulous patients rehabilitated until 2020 ie a minimum of 3 years of function time with at least two contiguous implant-supported restorations in the maxilla or mandible
Screw or cemented-retained prosthesis
Fixed dental prosthesis ie single crowns and partial prosthesis
No implant mobility
Moreover the exclusion criteria will be the following
Pregnant and lactating women
Patients who have taken systemic antibiotics during the 3 months prior to the examination
Patients being treated with drugs that may induce a gingival overgrowth
Patients undergoing orthodontic treatment since it can influence periodontal diagnosis
Patients who have received mechanical debridement during the 3 months prior to the exam
Patients who have received surgical treatment for peri-implantitis
Psychophysical inability to carry out study procedures
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None