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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Peri-Implantitis; Peri-implant Mucositis
• Intervention / Treatment: 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.

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 Type: Observational
• Enrollment (Estimated): 180

Contacts and Locations

• Study Contact: Name: Ioannis Terpou, MSc; Phone Number: +306978218177; Email: ioannisterpou.95@uic.es
• Study Contact Backup: Name: Tiago R Amaral, MSc; Phone Number: +351916067069; Email: tiagoamaral@edu.ulisboa.pt

Study Locations

• Spain
  • Barcelona
    • Sant Cugat Del Vallès, Barcelona, Spain, 08195
      • Clínica Universitaria de Odontologia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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).

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Inter-implant distance ≤ 3mm; Presence of an inter-implant distance ≤ 3mm	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.
Inter-implant distance ≥ 3mm; Presence of an inter-implant distance ≥ 3mm	Diagnostic test: Two contiguous dental implants placed with > 3mm from each other.; Implant Placement of 2 contiguous dental implants with > 3mm from each other.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Universitat Internacional de Catalunya
• Investigators: Study Director: Cristina V Vallès, PhD, Department of Periodontology, University Internacional de Cataluña

Study record dates

Study Major Dates

• Study Start (Estimated): April 5, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: January 31, 2024
• First Submitted That Met QC Criteria: April 10, 2024
• First Posted (Estimated): April 15, 2024

Study Record Updates

• Last Update Posted (Estimated): April 15, 2024
• Last Update Submitted That Met QC Criteria: April 10, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Peri-implantitis; Peri-implant mucositis; Peri-implant diseases; Inter-implant distances
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Mucositis; Peri-Implantitis
• Other Study ID Numbers: PER-ECL-2023-05

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No