Effectiveness of Plaque Score Detection Techniques

NCT ID: NCT06511830

Last Updated: 2025-06-11

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-11-20
• Study Completion Date: 2026-06-30

Brief Summary

This study investigates the similarity between microbial plaque scores when assessing the entire dentition versus select teeth. The hypothesis posits that plaque buildup on single teeth mirrors that of the entire mouth, facilitating efficient plaque data collection and generalized deductions. Additionally, the research explores the potential of Dental Monitoring© photos in accurately identifying plaque indexes, aiming to enhance plaque evaluation efficiency in dental appointments. The null hypothesis suggests no significant difference between full dentition plaque scores and selected teeth. Results may streamline plaque tracking in patient appointments and enable remote monitoring, potentially detecting plaque accumulation issues earlier.

Detailed Description

Following the obtainment of participant consent, data will be collected during participant's routine prophylaxis appointment or during designated clinic time open for participants to volunteer. Utilizing a scan box provided by Dental Monitoring©, a scan (series of intra-oral images) will be taken of the participant's dentition. The scan will be taken once before disclosing solution (erythrosine) is introduced to the dentition and once after.

The disclosing solution will allow for visualization of plaque. The presence of plaque on all teeth surfaces will be recorded using the O'Leary Plaque Index. No procedures (other than the intra-oral photos), interventions, evaluations or tests will be performed more frequently than they would be if the participant was not participating in the research. The only participant demographic information that will be recorded for this study is age.

Participants who opt to come in voluntarily for only data collection will not receive a prophylaxis. Their plaque information will be collected, and they will be dismissed.

Oversight procedures in place: The Scan Boxes will be utilized by the investigators to take intra-oral photographs of each patient's dentition. These will be sterilized between each participant and stored in the College of Dentistry's clinic lockers when not in use.

Conditions

Plaque, Dental

Study Design

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

Interventions

Dental Monitoring images

Dental Monitoring is a series of intraoral photos that will be taken and assessed to determine the subject's dental plaque levels.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• 19-85 years old
• Patient at the University of Nebraska Medical Center (UNMC) College of Dentistry
• One molar, premolar or canine pe quadrant

Exclusion Criteria

• No permanent dental devices (braces, splints)
• Less than 20 non-restored teeth present in the dentition

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Nebraska

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amy Killeen, DDS, MS

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska

Locations

University of Nebraska Medical Center Dental College

Lincoln, Nebraska, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Amy Killeen, DDS, MS

Role: CONTACT

akilleen@unmc.edu

402-472-7848

Facility Contacts

James Wahl, PhD

Role: primary

jwahl@unmc.edu

402-472-1324

Other Identifiers

0341-24-FB

Identifier Type: -

Identifier Source: org_study_id