Rapid Point-of-Care Salivary Diagnostic for Periodontal Health

Status Terminated

Clinical Trial Summary

The purpose of this study is to learn if a chair-side testing device will accurately measure levels of a salivary biomarker and thus indicate if a patient has periodontal health, gingivitis or periodontal disease.

Clinical Trial Description

Human subjects will participate in this cross-sectional study by attending a single visit where their mouth will be examined and saliva will be collected to help determine the accuracy of a POC salivary diagnostic device. The study population will consist of 174 persons (58 that are orally healthy and have no oral discomfort; 58 that have gingivitis; and 58 that have periodontitis. The device results (i.e., visual and optical scans) will be compared against the Luminex results by two methods: 1) the Bland-Altman procedure and 2) discriminant analysis that examines whether the concentration would correctly identify the subject as health or disease using a defined threshold for MMP-8 levels.

Three groups of individuals will be recruited: those that are orally healthy and do not have any oral discomfort (N=58), those who have gingivitis (i.e., bleeding gums; N=58), and those who have periodontal disease (N=58). The groups will be matched by gender and smoking status. Women are predicted to account for 50% of the participants. The age distribution will be 18 to 95 years. Subjects will not be excluded based on race, gender, or ethnicity. ;

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02403297
Study type	Observational
Source	Innovative Diagnostics Inc
Contact
Status	Terminated
Phase	N/A
Start date	March 2015
Completion date	May 2016

View Details

See also
Status	Clinical Trial	Phase
Not yet recruiting	`NCT05568290` - Interleukin-38 Levels in Individuals With Periodontitis
Completed	`NCT04402996` - Meteorin-like Levels in Individuals With Periodontitis
Not yet recruiting	`NCT06016023` - Evaluation of Macrophage Inflammatory Protein-1α as a Periodontal Disease Biomarker
Not yet recruiting	`NCT05497895` - The Assessment of Clinical Efficacy of Topical Application of 5% Thymoquinone Gel for Gingivitis Patients	Early Phase 1
Completed	`NCT02633345` - Effects on Tablets Containing Probiotic Candidate Strains	N/A
Completed	`NCT02884817` - Essential Oil+ELA, Plaque and Gingivitis	Phase 4
Completed	`NCT02552589` - Effect of Toothpaste on the Reduction of Plaque and Inflammation	N/A
Completed	`NCT02235532` - Effects of Aloe Vera Toothpaste on Periodontal Parameters	N/A
Completed	`NCT02515929` - Prospective Double-Blind Randomized Controlled Clinical Trial in the Gingivitis Prevention With OPCs	Phase 4
Unknown status	`NCT01956656` - Efficacy Of Lotus Leaves In Management Of Plaque Induced Gingivitis	N/A
Completed	`NCT02980497` - Antiplaque/Antigingivitis Efficacy of Essential Oil Mouthrinses in Six-Month Study	N/A
Completed	`NCT01941797` - Experimental Peri-implant Mucositis in Humans	N/A
Completed	`NCT02508987` - Obesity and Oxidative Stress in Patients With Different Periodontal Status	N/A
Unknown status	`NCT01197105` - Evaluation Study of a Mouthwash Based on Schinus Terebinthifolius to Treat Gingivitis in Children	Phase 1/Phase 2
Completed	`NCT01593540` - Clinical Examination of Metal Free Interdental Brushes	Phase 4
Completed	`NCT01236963` - Essential Oils Mouth Rinse and Dental Floss: Efficacy on Interproximal Gingivitis and Dental Plaque Accumulation	N/A
Completed	`NCT02102295` - Effects of Antioxidant Dentifrice on Gingivitis	Phase 3
Completed	`NCT06140784` - A Clinical Study to Assess the Gingivitis and Plaque Effects of Various Dentifrices	N/A
Completed	`NCT02937636` - To Investigate the Gingivitis Efficacy of a Stannous Fluoride Dentifrice in a Chinese Population	N/A
Completed	`NCT06212908` - Assessment of Periodontal Therapy and Biofilm Management in Breast Cancer	N/A