Sensitivity and Specificity of Peri-Implantitis-Related Parameters

Sensitivity and Specificity of Peri-Implantitis-Related Parameters: A Case-Control Study

Bleeding on probing demonstrated to have high specificity with certain level of sensitivity to detect periodontal disease. Again, understanding the weak hemidesmosome attachment to the implant surface is imperative to discern on the probe penetration extent and subsequent bleeding. In the presence of inflammation, bleeding should be present indicating high sensitivity when probing deeper sites; nevertheless the lack thereof in healthy condition does not seem to translate high specificity. In this sense, it is noteworthy to mention that the mucogingival shift after implant placement often decreases the presence of keratinized mucosa, triggering a greater inflammatory condition on the peri-implant tissues. Thereupon, bleeding on probing, although might reliably indicate presence of disease, it does not seem to be a suitable diagnostic parameter. On the other side, suppuration characterizes the necrosis of peri-implant tissues, being rich in polymorphonuclear cells and as such, a sensitive indicator of bone turnover. In this sense, it must be noted that, if detected in early stages where bone resorption has not occurred yet, it might be a consequence of a foreign body reaction (i.e., residual cement or floss).

Therefore, in the diagnosis of peri-implantitis, radiographic examination must be always incorporated to the clinical assessment as the 'gold standard'. Hence, the aim of this case-control study was to assess the diagnostic accuracy of peri-implantitis-related clinical parameters compared to otherwise healthy dental implants.

Study Overview

• Status: Completed
• Conditions: Peri-Implantitis; Peri-implant Mucositis; Sensitivity; Peri-Implantational Loss
• Intervention / Treatment: Diagnostic test: Sensitivity test

Detailed Description

All subjects enrolled had to be consecutively evaluated in a routine peri-implant maintenance t with dental implants for fixed prosthesis rehabilitation with a minimum period of 12 months after final prosthesis delivery. Patients were contacted and informed to participate in a cross-sectional assessment to identify the presence of peri-implant diseases. Eligible implants had to be in an ideal prosthetically driven position, otherwise they were excluded from the analysis. Moreover, implants that could not be accurately recorded the probing depth due to inadequate prosthesis design were further excluded. Baseline periapical x-ray at time of prosthesis delivery was retrospective assessed to exclude implants with early peri-implant bone loss before function. A detailed description of risk factors and indicators of peri-implant disease were explained at the same stage. Additionally, patients were thoroughly instructed on plaque control home care strategies including but not limited to interdental brushes with nylon-coated core wire, soft toothbrushes (manual and power) and floss with stiffened end to clean under multiple units fixed-prosthesis. Moreover, treated patients were encouraged to routinely enroll in a peri-implant maintenance therapy program.

The present case-control study will be conducted in accordance with the Helsinki declaration of human studies and received approval from the ethics committee from the University of Extremadura (Badajoz, Spain). An informed written consent was signed from each subject enrolled in the present study.

• Study Type: Observational
• Enrollment (Actual): 141

Contacts and Locations

Study Locations

• Spain
  • Badajoz, Spain, 06001
    • Centro de Implantologia Cirugia Oral y Maxiofacial

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients will be either approached during their biannual peri-implant maintenance recall appointment or contacted and asked to participate in a free clinical and radiographic examination to identify the possible presence of peri-implant pathology.

Description

Inclusion Criteria:

• patients within the age range of 18 to 80,
• non- or light smokers (<10cigarettes/day),
• no presence of infectious diseases at the time of implant placement or during the maintenance program,
• no presence of serious disease or condition known to alter bone metabolism,
• partial edentulous patients with stable periodontal condition with or without history of chronic periodontitis.

Exclusion Criteria:

• pregnancy,
• history of heavy smoking,
• uncontrolled medical conditions such as diabetes mellitus,
• not adequate implant position (i.e., prosthetically driven),
• not properly restored impeding accurate probing depth recording
• lack of keratinized mucosa

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Peri-implantitis; Individuals with implants ≥2mm of radiographic bone loss	Diagnostic test: Sensitivity test; Routine clinical and radiographic examination
non-peri-implantitis patients; Individuals with implants <2mm of radiographic bone loss	Diagnostic test: Sensitivity test; Routine clinical and radiographic examination

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity to detect peri-implantitis	Capability to diagnose disease	1 year
Specificity to detect peri-implantitis	Capability to diagnose health	1 year

Collaborators and Investigators

• Sponsor: Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain
• Investigators: Study Director: Florencio Monje Gil, Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2016
• Primary Completion (ACTUAL): April 1, 2017
• Study Completion (ACTUAL): April 2, 2017

Study Registration Dates

• First Submitted: January 20, 2017
• First Submitted That Met QC Criteria: January 23, 2017
• First Posted (ESTIMATE): January 25, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 11, 2017
• Last Update Submitted That Met QC Criteria: May 10, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Immune System Diseases; Gastrointestinal Diseases; Gastroenteritis; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Hypersensitivity; Mucositis; Peri-Implantitis
• Other Study ID Numbers: 18002909/3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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