Diagnostic Accuracy of Matrix Metalloproteinase-8 Test for the Discrimination of Periodontal Health and Disease

NCT05099731 | Completed

• 1 other identifier: Pilotstudy0818
• Study Type: observational
• Target: 95
• Locations: 1 country
• Sites: 1

Brief Summary

The application of point-of-care test with oral fluid-based biomarkers assisting in early-detection of gum disease is highly needed. Recently, a commercially available active Matrix metalloproteinase-8 (aMMP-8) point-of-care test (POCT) for detecting the risk of gum disease has been developed. Currently, there is a paucity of research to assess the performance of aMMP-8 POCT using different oral fluid sampling methods. This study will evaluate the accuracy of aMMP-8 POCT for discriminating periodontal health from disease in saliva and oral rinse.The information obtained from this study may help us understand better which sample is superior for the early detection of gum disease.

Conditions

Periodontitis; Diagnostic Self Evaluation

Outcome Measures

Primary Outcomes (1)

• The area under the receiver operating characteristic curve (AUROC) measure

  Comparing the area under the receiver operating characteristic curve (AUROC) of aMMP-8 in different samples to correctly identify periodontitis cases at the time of completion of clinical examination

  1day

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consenting untreated patients seeking care at the Periodontology clinic and Implant Dentistry clinic of Shanghai Ninth People's Hospital.

You may qualify if:

• Aged 18 and above
• Ability and willingness to give written informed consent

You may not qualify if:

• Edentulous mouth
• Pregnant females
• Having received professional periodontal treatment (other than supragingival cleaning) within the previous 12 months
• Having received antibiotic medication within the previous 3 months
• Presence of xerostomia interfering with saliva sampling
• Inability or unwillingness of individual to give written informed consent

Sponsors & Collaborators

• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University: lead

Study Sites (1)

Department of Oral and Maxillofacial Implantology

Shanghai, Shanghai Municipality, 200000, China

Location

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 26, 2021
• First Posted: October 29, 2021
• Study Start: October 10, 2021
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2021
• Last Updated: March 31, 2022

Record last verified: 2022-03

Locations

CN (1)