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Sensitivity and Specificity of Peri-Implantitis-Related Parameters

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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

Tracking Information
First Submitted Date January 20, 2017
First Posted Date January 25, 2017
Last Update Posted Date May 11, 2017
Actual Study Start Date July 1, 2016
Actual Primary Completion Date April 1, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 23, 2017)
  • Sensitivity to detect peri-implantitis [ Time Frame: 1 year ]
    Capability to diagnose disease
  • Specificity to detect peri-implantitis [ Time Frame: 1 year ]
    Capability to diagnose health
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Sensitivity and Specificity of Peri-Implantitis-Related Parameters
Official Title Sensitivity and Specificity of Peri-Implantitis-Related Parameters: A Case-Control Study
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.

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
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Sensitivity
  • Peri-implant Mucositis
  • Peri-Implantational Loss
  • Peri-Implantitis
Intervention Diagnostic Test: Sensitivity test
Routine clinical and radiographic examination
Study Groups/Cohorts
  • Peri-implantitis
    Individuals with implants ≥2mm of radiographic bone loss
    Intervention: Diagnostic Test: Sensitivity test
  • non-peri-implantitis patients
    Individuals with implants <2mm of radiographic bone loss
    Intervention: Diagnostic Test: Sensitivity test
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 16, 2017)
141
Original Estimated Enrollment
 (submitted: January 23, 2017)
200
Actual Study Completion Date April 2, 2017
Actual Primary Completion Date April 1, 2017   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT03031392
Other Study ID Numbers 18002909/3
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain
Study Sponsor Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain
Collaborators Not Provided
Investigators
Study Director: Florencio Monje Gil Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain
PRS Account Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain
Verification Date January 2017