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

NCT ID: NCT06784362

Last Updated: 2025-01-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 230 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-12-05
• Study Completion Date: 2024-01-29

Brief 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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Healthy group

individuals without periodontitis or peri-implantitis

No intervention

Intervention Type: OTHER

This is an observational study

untreated group

individuals with periodontitis or peri- implantitis who have been informed of the need for treatment - but have decided not to have treatment (untreated group)

No intervention

Intervention Type: OTHER

This is an observational study

high risk group

individuals who received treatment for periodontitis or peri-implantitis and are now receiving regular dental hygiene care every 3 months (high risk group).

No intervention

Intervention Type: OTHER

This is an observational study

Interventions

No intervention

This is an observational study

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Subjects with disease (cases) were diagnosed with generalized chronic severe periodontitis with at least five teeth having clinical evidence of disease [clinical attachment loss (CAL) ≥ 5mm, at least one site with probing depth (PD) ≥ 7 mm] and radiographic evidence of at least 30% bone loss
• Control subjects exhibited a healthy periodontium (no PD >3 mm. no site with CAL) with no radiographic evidence of bone loss.
• Case and control subjects were in good general health.

Exclusion Criteria

• uncontrolled systemic disease, such as diabetes;
• systemic antibiotic use within the past 3 months;
• unable to provide consent; and
• history of periodontal treatment or local antibiotic use in the past 12 months;
• use of NSAIDs in the past 3 weeks.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

#1511M79922

Identifier Type: -

Identifier Source: org_study_id