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NCT Number: NCT06364982

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clínica Universitaria de Odontologia

Sant Cugat del Vallès, Barcelona, 08195, Spain

Location status: Recruiting

Location contact

Enrique Roldan, Dentist

CONTACT

[email protected]

935042030 ext. +34

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Prevalence of peri-implant diseases.

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

    Prevalence of peri-implant mucositis and peri-implantitis.

Secondary outcomes

  1. FMPI

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

    Full Mouth Plaque Index

  2. FMBI

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

    Full Mouth Bleeding Index

  3. mPI

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

    modified Plaque Index

  4. mBI

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

    modified Bleeding Index

  5. SoP

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

    Suppuration on Probing

  6. PPD

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

    Probing Pocket Depth

  7. MR

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

    Mucosal Recession

  8. KM

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

    Keratinized Mucosa

  9. Implant location

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

    Implant location in the oral cavity

  10. Implant position

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

    Implant position in the oral cavity

  11. Implant type

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

    Implant type used

  12. Implant brand

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

    Brand of the implant used

  13. Implant roughness

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

    Type of implant roughness

  14. Implant diameter

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

    Type of implant diameter

  15. Implant length

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

    Length of the implant

  16. Apico-coronal position of the implant

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

    Apico-coroal position

  17. Inter-implant distances (IID)

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

    Inter-implant distance

  18. Implant placement protocol

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

    Moment of the implant placement

  19. Bone grafting procedures (BGP) at implant placement

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

    Bone grafting associated with the implant placement

  20. Implant-supported restorations

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

    Screwed or Cemented

  21. Cleansability of the prosthesis

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

    Cleansable, difficult or impossible to clean

Study contacts

Contact information is provided by the study sponsor or research team.

Ioannis Terpou, MSc

CONTACT

[email protected]

+306978218177

Tiago R Amaral, MSc

CONTACT

[email protected]

+351916067069

Sponsors and collaborators

Lead sponsor

Universitat Internacional de Catalunya

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 15, 2024
Registry last updated
Jul 17, 2024

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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