Last reviewed · How we verify

NCT03031392

Sensitivity and Specificity of Peri-Implantitis-Related Parameters

Completed Last updated 11 May 2017
What this trial tests

trial testing Sensitivity test in Sensitivity in 141 participants. Completed in 2 April 2017.

Timeline
1 July 2016
Primary endpoint
1 April 2017
2 April 2017

Quick facts

Lead sponsorCenter of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain
StatusCompleted
Study typeOBSERVATIONAL
Enrollment141
Start date1 July 2016
Primary completion1 April 2017
Estimated completion2 April 2017
Sites1 location across Spain

Drugs / interventions tested

Conditions studied

Sponsor

Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain — full company profile →

Who can join

Adults 18 to 80, any sex, with Sensitivity or Peri-implant Mucositis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

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

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03031392.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing