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

Recruiting

• Conditions: Peri-Implantitis; Peri-implant Mucositis
• Interventions: Diagnostic Test: Two contiguous dental implants placed with less ≤ 3mm from each other.; Diagnostic Test: Two contiguous dental implants placed with > 3mm from each other.

• Registration Number: NCT06364982
• Lead Sponsor: Universitat Internacional de Catalunya

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 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.

Study Timeline

• Study First Submitted: 2024-01-31
• Study Start: 2024-04-05
• Study First Submitted QC: 2024-04-10
• Study First Posted: 2024-04-15
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-16
• Last Update Posted: 2024-07-17
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 180

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Inter-implant distance ≤ 3mm	Two contiguous dental implants placed with less ≤ 3mm from each other.	Presence of an inter-implant distance ≤ 3mm
Inter-implant distance ≥ 3mm	Two contiguous dental implants placed with > 3mm from each other.	Presence of an inter-implant distance ≥ 3mm

Primary Outcome Measures

Name	Time	Method
Prevalence of peri-implant diseases.	At least 36 months of function - at the moment of the evaluation	Prevalence of peri-implant mucositis and peri-implantitis.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Clínica Universitaria de Odontologia; 🇪🇸 Sant Cugat Del Vallès, Barcelona, Spain