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Diagnostic and Prognostic Test for Periodontitis and Peri-implantitis (AHC-FRDgrant)

NCT06784362 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 230

Last updated 2025-01-20

No results posted yet for this study

Summary

The dental community, dental insurance companies and the public are becoming increasingly aware of the high prevalence of gum disease around teeth (periodontitis) and around dental implants (peri-implantitis). To date, it cannot be accurately predicted which individuals will develop or re-develop periodontitis or peri-implantitis, leading most dental patients to undergo unnecessary treatment and undue risks and costs. Gingival fluid is a serum-like fluid that diffuses into the oral cavity by flowing between the gum and the tooth or dental implant.

Oral bacteria that grow around teeth and dental implants induce inflammation and change the amount and composition of the gingival fluid. The study hypothesizes that the spectra of metabolites in the inflammatory transudates and exudates around teeth and dental-implants are predictors of future periodontitis or peri-implantitis. The first objective is to use proton nuclear magnetic resonance (H-NMR) spectroscopy in a cross-sectional study to map mapping the metabolites in the gingival fluid that are capable of discriminating between healthy gum tissue and gum tissue that shows signs of periodontitis or dental peri-implantitis. The second objective is to begin prospective measurement of gingival fluid metabolites every 6 months in (i) individuals without periodontitis or peri-implantitis (healthy group), (ii) individuals with periodontitis or peri- implantitis who have been informed of the need for treatment - but have decided not to have treatment (untreated group) and (iii) individuals who received treatment for periodontitis or peri-implantitis and are now receiving regular dental hygiene care every 3 months (high risk group). By defining metabolites that can discriminate health from disease (Aim 1) and by measuring proportional changes of key metabolites relative to disease progression over time (Aim 2), the study will be able to predict in a site-specific manner, (a) the risk of disease initiation in people who do not initially have periodontitis or peri-implantitis (healthy persons), and (b) disease progression in untreated people or in people who were treated and are currently in a dental hygiene maintenance program. Accomplishing these two aims will provide a foundation from which to increase the efficacy of prevention whilst abating the morbidity and cost associated with current clinical practice.

Conditions

  • Periodontal Diseases
  • Periodontitis
  • Peri-Implantitis

Interventions

OTHER

No intervention

This is an observational study

Sponsors & Collaborators

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-12-05
Primary Completion
2024-01-29
Completion
2024-01-29

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06784362 on ClinicalTrials.gov