Sensitivity and Specificity of Peri-Implantitis-Related Parameters

NCT03031392 | Completed

• 1 other identifier: 18002909/3
• Study Type: observational
• Target: 141
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sensitivity; Peri-implant Mucositis; Peri-Implantational Loss; Peri-Implantitis

Outcome Measures

Primary Outcomes (2)

• Sensitivity to detect peri-implantitis

  Capability to diagnose disease

  1 year

• Specificity to detect peri-implantitis

  Capability to diagnose health

  1 year

Study Arms (2)

Peri-implantitis

Individuals with implants ≥2mm of radiographic bone loss

Diagnostic Test: Sensitivity test

non-peri-implantitis patients

Individuals with implants \<2mm of radiographic bone loss

Diagnostic Test: Sensitivity test

Interventions

Sensitivity test DIAGNOSTIC_TEST

Routine clinical and radiographic examination

Peri-implantitis; non-peri-implantitis patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain: lead

Study Sites (1)

Centro de Implantologia Cirugia Oral y Maxiofacial

Badajoz, 06001, Spain

Location

MeSH Terms

Conditions

Hypersensitivity; Peri-Implantitis

Condition Hierarchy (Ancestors)

Immune System Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Florencio Monje Gil

  Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2017
• First Posted: January 25, 2017
• Study Start: July 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: April 2, 2017
• Last Updated: May 11, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)