NCT06443853

Brief Summary

It is aimed to compare dental plaque area measured on images obtained in the clinic by using dental photography and intraoral scanner and to evaluate the correlation of this area with clinical plaque scores. Clinical dental plaque scoring was measured according to the "Turesky Modified Quigley Hein Plaque Index" after applying a plaque staining agent (Tri Plaque ID Gel, GC Corp., Tokyo, Japan) to evaluate the oral hygiene of 20 patients who applied to the university clinic. Following clinical scoring, intraoral photographs of the patients were taken using dental photography equipment of the same standards (EOS700D, Canon; 100mm lens, Canon; twin flash, Yong Nuo) and scan images were taken with an intraoral scanner (iTero Element Flex, Align Tech., USA). In the data obtained, dental plaque area on the buccal surface of 66 lower and upper jaw anterior teeth were measured with Image J (National Institute for Health, Bethesda, USA) software, and the ratio of dental plaque area to the visible surface area of the tooth was measured.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2024

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 29, 2024

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 30, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 5, 2024

Completed
Last Updated

June 5, 2024

Status Verified

May 1, 2024

Enrollment Period

28 days

First QC Date

May 30, 2024

Last Update Submit

May 30, 2024

Conditions

Keywords

dental plaquedental plaque scoringdental plaque imaging

Outcome Measures

Primary Outcomes (1)

  • Correlation between Turesky Modified Quigley Hein Plaque Scores and dental plaque coated surface areas on the images taken by digital camera and intraoral scanner

    The Turesky Modified Quigley Hein Plaque Index (TMQHPI) of anterior teeth of the volunteers' was recorded using clinical visual examination.Intraoral photographs of the volunteers were taken by using a digital camera and 3D images were recorded by an intraoral scanner.The plaque-covered area and the total surface area of the teeth were marked in the manual mode of the Image J program and the areas were measured.

    1 month

Study Arms (3)

Clinical scoring

The Turesky Modified Quigley Hein Plaque Index of anterior teeth of the volunteers' was recorded using clinical visual examination after dental plaque staining.

Diagnostic Test: Dental plaque scoring and dental plaque coated tooth surface measuring

Digital Camera

Intraoral photographs of the volunteers were taken by using a digital camera (Canon EOS 700D; 100 mm macrolens, Canon Inc., Tokyo, Japan). All taken photographs were transferred to the Image J V1.53 (National Institute for Health, Bethesda, USA) program. The plaque-covered area and the total surface area of the teeth were marked in the manual mode of the program.

Diagnostic Test: Dental plaque scoring and dental plaque coated tooth surface measuring

Intraoral Scanner

3D images of the volunteers were recorded by an intraoral scanner (iTero Element Flex, Align Technologies, San Jose, California, USA). All taken images were transferred to the Image J V1.53 (National Institute for Health, Bethesda, USA) program. The plaque-covered area and the total surface area of the teeth were marked in the manual mode of the program.

Diagnostic Test: Dental plaque scoring and dental plaque coated tooth surface measuring

Interventions

The Turesky Modified Quigley Hein Plaque Index of anterior teeth of the volunteers' was recorded using clinical visual examination. Intraoral photographs of the volunteers were taken by using a digital camera and 3D images were recorded by an intraoral scanner. The plaque-covered area and the total surface area of the teeth were marked in the manual mode of the Image J program and the areas were measured in square pixels. The correlation between clinical visual scoring, dental plaque areas on images were compared.

Clinical scoringDigital CameraIntraoral Scanner

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The study included 20 patients between the age of 18 to 45. Among the patients with orthodontic brackets, severe tooth crowding that could not be visually verified on images, fixed or implant restorations were excluded in the study. Measurements were made on a total of 66 teeth, which can be easily seen on the images.

You may qualify if:

  • Patients without orthodontic brackets, fixed or implant restorations and without severe tooth crowding were included in the study.

You may not qualify if:

  • Among the patients with orthodontic brackets, severe tooth crowding that could not be visually verified on images, fixed or implant restorations were excluded in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University, Department of Restorative Dentistry

Istanbul, Maltepe, 34854, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dental Plaque

Condition Hierarchy (Ancestors)

Dental DepositsTooth DiseasesStomatognathic Diseases

Study Officials

  • Dilek Tagtekin, Professor

    Marmara University

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

May 30, 2024

First Posted

June 5, 2024

Study Start

March 1, 2024

Primary Completion

March 29, 2024

Study Completion

April 5, 2024

Last Updated

June 5, 2024

Record last verified: 2024-05

Locations