Dental PlaqueNCT06443853
Creating Digital Dental Plaque Scoring
An observational study of Dental Plaque, run by Marmara University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Plaque
- What is being tested?
- Dental plaque scoring and dental plaque coated tooth surface measuring
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2024to 5 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- Patients without orthodontic brackets, fixed or implant restorations and without severe tooth crowding were included in the study.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University, Department of Restorative Dentistry
Istanbul, Maltepe, 34854
About this study
Official title: A Novel Approach to Digital Dental Plaque Scoring
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.
Read the detailed description
The (h1) hypothesis of this study was that dental plaque scores measured through digital camera and intraoral scanner images can replace clinical visual scoring. This study aimed to compare dental plaque areas measured on images taken by digital camera and intraoral scanner and to evaluate these areas with clinical plaque scores with the help of a software program and provide a novel plaque index to score dental plaque on the taken intraoral images.
Study Design The tooth arches of the volunteers were stained with a plaque-disclosing solution (Tri Plaque ID Gel, GC Corporation, Tokyo, Japan). 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 (Canon EOS 700D; 100 mm macrolens, Canon Inc., Tokyo, Japan), and 3D images were recorded by an intraoral scanner (iTero Element Flex, Align Technologies, San Jose, California, USA). Photograph and intraoral scanner images were overlapped and pixel-synchronized using the Keynote program.
After synchronization, 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 and the areas were measured in square pixels. Measurements were made on a total of 66 teeth, which can be easily seen on the images. Intraoral scanner plaque area/ tooth surface area ratio and intraoral photograph plaque area/ tooth surface area ratio were calculated and recorded for each tooth.
- Conditions
- Dental Plaque
- Being tested
- Dental plaque scoring and dental plaque coated tooth surface measuring
- Keywords
- dental plaque, dental plaque scoring, dental plaque imaging
- Medical subject headings
- Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental plaque scoring and dental plaque coated tooth surface measuringDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Diagnostic Test: Dental plaque scoring and dental plaque coated tooth surface measuring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2024
- Study start1 Mar 2024
- Primary completion29 Mar 2024
- Study completion5 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental PlaqueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dilek Tagtekin, Professor, Study director, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06443853
- Sponsor's protocol ID
- Digital Scoring
- Status last verified
- May 2024
- First submitted
- 30 May 2024
- Last updated
- 5 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Approach to Digital Dental Plaque Scoring
- ClinicalTrials.gov ID
- NCT06443853
- Acronym / sponsor ID
- Digital Scoring
- Conditions
- Dental Plaque
- Keywords
- dental plaque, dental plaque scoring, dental plaque imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 29 Mar 2024 (actual)
- Study completion
- 5 Apr 2024 (actual)
- First posted
- 5 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The (h1) hypothesis of this study was that dental plaque scores measured through digital camera and intraoral scanner images can replace clinical visual scoring. This study aimed to compare dental plaque areas measured on images taken by digital camera and intraoral scanner and to evaluate these areas with clinical plaque scores with the help of a software program and provide a novel plaque index to score dental plaque on the taken intraoral images.
Study Design The tooth arches of the volunteers were stained with a plaque-disclosing solution (Tri Plaque ID Gel, GC Corporation, Tokyo, Japan). 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 (Canon EOS 700D; 100 mm macrolens, Canon Inc., Tokyo, Japan), and 3D images were recorded by an intraoral scanner (iTero Element Flex, Align Technologies, San Jose, California, USA). Photograph and intraoral scanner images were overlapped and pixel-synchronized using the Keynote program.
After synchronization, 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 and the areas were measured in square pixels. Measurements were made on a total of 66 teeth, which can be easily seen on the images. Intraoral scanner plaque area/ tooth surface area ratio and intraoral photograph plaque area/ tooth surface area ratio were calculated and recorded for each tooth.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Clinical scoring | – | Diagnostic Test: Dental plaque scoring and dental plaque coated tooth surface measuringThe Turesky Modified Quigley Hein Plaque Index of anterior teeth of the volunteers' was recorded using clinical visual examination after dental plaque staining. |
| Digital Camera | – | Diagnostic Test: Dental plaque scoring and dental plaque coated tooth surface measuringIntraoral 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. |
| Intraoral Scanner | – | Diagnostic Test: Dental plaque scoring and dental plaque coated tooth surface measuring3D 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (1 listed)
- Patients without orthodontic brackets, fixed or implant restorations and without severe tooth crowding were included in the study.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dental plaque scoring and dental plaque coated tooth surface measuringThe 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. | Diagnostic test | Clinical scoring, Digital Camera, Intraoral Scanner |
Primary outcome
Correlation between Turesky Modified Quigley Hein Plaque Scores and dental plaque coated surface areas on the images taken by digital camera and intraoral scanner
Time frame: 1 month
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dilek Tagtekin, Professor study director
Marmara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Plaque, run by Marmara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between Turesky Modified Quigley Hein Plaque Scores and dental plaque coated surface areas on the images taken by digital camera and intraoral scanner (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2024.