NCT06511830

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
1mo left

Started Nov 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress96%
Nov 2024Jun 2026

First Submitted

Initial submission to the registry

July 15, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 22, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

November 20, 2024

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

June 11, 2025

Status Verified

June 1, 2025

Enrollment Period

1.5 years

First QC Date

July 15, 2024

Last Update Submit

June 9, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Presence of Visibly Detectable Plaque

    The presence of dental plaque will be determined by visual presence or absence of dental plaque at 6 sites per tooth. The presence of dental plaque is reported as a percentage of tooth surfaces with visibly detectable plaque.

    Baseline

Interventions

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

Eligibility Criteria

Age19 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants will be routine patients at the UNMC College of Dentistry clinics.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nebraska Medical Center Dental College

Lincoln, Nebraska, 68583-0740, United States

RECRUITING

MeSH Terms

Conditions

Dental Plaque

Condition Hierarchy (Ancestors)

Dental DepositsTooth DiseasesStomatognathic Diseases

Study Officials

  • Amy Killeen, DDS, MS

    University of Nebraska

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amy Killeen, DDS, MS

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2024

First Posted

July 22, 2024

Study Start

November 20, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

June 11, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations