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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversitat Internacional de Catalunya

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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);

Disqualifiers

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);

Trial 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).

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

  • Two contiguous dental implants placed with less ≤ 3mm from each other.

    Diagnostic test

    Implant Placement of 2 contiguous dental implants with less ≤ 3mm from each other.

  • Two contiguous dental implants placed with > 3mm from each other.

    Diagnostic test

    Implant Placement of 2 contiguous dental implants with \> 3mm from each other.

Treatment groups

180 Participants
are divided into 2 treatment groups
Group A: Inter-implant distance ≤ 3mm1 intervention
Group B: Inter-implant distance ≥ 3mm1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

FMPI

Full Mouth Plaque Index

Time frame
At least 36 months of function - at the moment of the evaluation
2

FMBI

Full Mouth Bleeding Index

Time frame
At least 36 months of function - at the moment of the evaluation
3

mPI

modified Plaque Index

Time frame
At least 36 months of function - at the moment of the evaluation
4

mBI

modified Bleeding Index

Time frame
At least 36 months of function - at the moment of the evaluation

Other outcomes

Sponsors and contacts

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