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Sensitivity and Specificity of Peri-Implantitis-Related Parameters

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03031392
Recruitment Status : Completed
First Posted : January 25, 2017
Last Update Posted : May 11, 2017
Sponsor:
Information provided by (Responsible Party):
Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain

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.


Condition or disease Intervention/treatment
Sensitivity Peri-implant Mucositis Peri-Implantational Loss Peri-Implantitis 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.

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Study Type : Observational
Actual Enrollment : 141 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Sensitivity and Specificity of Peri-Implantitis-Related Parameters: A Case-Control Study
Actual Study Start Date : July 1, 2016
Actual Primary Completion Date : April 1, 2017
Actual Study Completion Date : April 2, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

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




Primary Outcome Measures :
  1. Sensitivity to detect peri-implantitis [ Time Frame: 1 year ]
    Capability to diagnose disease

  2. Specificity to detect peri-implantitis [ Time Frame: 1 year ]
    Capability to diagnose health



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03031392


Locations
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Spain
Centro de Implantologia Cirugia Oral y Maxiofacial
Badajoz, Spain, 06001
Sponsors and Collaborators
Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain
Investigators
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Study Director: Florencio Monje Gil Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain
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Responsible Party: Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain
ClinicalTrials.gov Identifier: NCT03031392    
Other Study ID Numbers: 18002909/3
First Posted: January 25, 2017    Key Record Dates
Last Update Posted: May 11, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Mucositis
Peri-Implantitis
Hypersensitivity
Immune System Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases
Periodontal Diseases