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

NCT06364982 | Recruiting

• 1 other identifier: PER-ECL-2023-05
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Peri-implant Mucositis; Peri-Implantitis

Keywords

Peri-implantitis; Peri-implant diseases; Peri-implant mucositis; Inter-implant distances

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (21)

• FMPI

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

• FMBI

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

• mPI

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

• mBI

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

• SoP

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

Study Arms (2)

Inter-implant distance ≤ 3mm

Presence of an inter-implant distance ≤ 3mm

Diagnostic Test: Two contiguous dental implants placed with less ≤ 3mm from each other.

Inter-implant distance ≥ 3mm

Presence of an inter-implant distance ≥ 3mm

Diagnostic Test: Two contiguous dental implants placed with > 3mm from each other.

Interventions

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.

Inter-implant distance ≤ 3mm

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

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

Inter-implant distance ≥ 3mm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitat Internacional de Catalunya: lead

Study Sites (1)

Clínica Universitaria de Odontologia

Sant Cugat del Vallès, Barcelona, 08195, Spain

RECRUITING

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Cristina V Vallès, PhD

  Department of Periodontology, University Internacional de Cataluña

  STUDY DIRECTOR

Central Study Contacts

Ioannis Terpou, MSc

CONTACT

+306978218177; ioannisterpou.95@uic.es

Tiago R Amaral, MSc

CONTACT

+351916067069; tiagoamaral@edu.ulisboa.pt

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD candidate

Study Record Dates

• First Submitted: January 31, 2024
• First Posted: April 15, 2024
• Study Start: April 5, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: July 17, 2024

Record last verified: 2024-07

Locations

ES (1)