Distance Between Dental Implants as a Risk Indicator for Peri-implant Disease.

Peri-Implantitis Clinical Trial

Official title:

Distance Between Dental Implants as a Risk Indicator for Peri-implant Disease. A Multi-center Cross-sectional Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06364982
• Other study ID #: PER-ECL-2023-05
• Status: Not yet recruiting
• Start date: April 5, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: Universitat Internacional de Catalunya
• Contact: Ioannis Terpou, MSc
• Phone: +306978218177
• Email: ioannisterpou.95[@]uic.es
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this study is to analyse contiguous dental implants and its peri-implant status depending on different inter-implant distances.

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 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:

• The patient must be ≥18 years of age and systemically healthy;

• Partially edentulous patients, rehabilitated until 2020 (i.e., 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 (i.e., 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 180
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• The patient must be =18 years of age and systemically healthy;

• Partially edentulous patients, rehabilitated until 2020 (i.e., 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 (i.e., single crowns and partial prosthesis);

• No implant mobility.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Mucositis
• Peri-implant Mucositis
• Peri-Implantitis

Intervention

Diagnostic Test:
• Two contiguous dental implants placed with less = 3mm from each other.
Implant Placement of 2 contiguous dental implants with less = 3mm from each other.
• Two contiguous dental implants placed with > 3mm from each other.
Implant Placement of 2 contiguous dental implants with > 3mm from each other.

Locations

Country	Name	City	State
Spain	Clínica Universitaria de Odontologia	Sant Cugat Del Vallès	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Universitat Internacional de Catalunya

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	FMPI	Full Mouth Plaque Index	At least 36 months of function - at the moment of the evaluation
Secondary	FMBI	Full Mouth Bleeding Index	At least 36 months of function - at the moment of the evaluation
Secondary	mPI	modified Plaque Index	At least 36 months of function - at the moment of the evaluation
Secondary	mBI	modified Bleeding Index	At least 36 months of function - at the moment of the evaluation
Secondary	SoP	Suppuration on Probing	At least 36 months of function - at the moment of the evaluation
Secondary	PPD	Probing Pocket Depth	At least 36 months of function - at the moment of the evaluation
Secondary	MR	Mucosal Recession	At least 36 months of function - at the moment of the evaluation
Secondary	KM	Keratinized Mucosa	At least 36 months of function - at the moment of the evaluation
Secondary	Implant location	Implant location in the oral cavity	At least 36 months of function - at the moment of the evaluation
Secondary	Implant position	Implant position in the oral cavity	At least 36 months of function - at the moment of the evaluation
Secondary	Implant type	Implant type used	At least 36 months of function - at the moment of the evaluation
Secondary	Implant brand	Brand of the implant used	At least 36 months of function - at the moment of the evaluation
Secondary	Implant roughness	Type of implant roughness	At least 36 months of function - at the moment of the evaluation
Secondary	Implant diameter	Type of implant diameter	At least 36 months of function - at the moment of the evaluation
Secondary	Implant length	Length of the implant	At least 36 months of function - at the moment of the evaluation
Secondary	Apico-coronal position of the implant	Apico-coroal position	At least 36 months of function - at the moment of the evaluation
Secondary	Inter-implant distances (IID)	Inter-implant distance	At least 36 months of function - at the moment of the evaluation
Secondary	Implant placement protocol	Moment of the implant placement	At least 36 months of function - at the moment of the evaluation
Secondary	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
Secondary	Implant-supported restorations	Screwed or Cemented	At least 36 months of function - at the moment of the evaluation
Secondary	Cleansability of the prosthesis	Cleansable, difficult or impossible to clean	At least 36 months of function - at the moment of the evaluation