Dental Plaque Imaging MethodsNCT05612009
Assessment of Different Imaging Systems for Dental Plaque Scoring
An observational study of Dental Plaque Imaging Methods, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to analyze the correlation between the dental plaque indices measured different imaging systems and conventional clinical indices that assess dental plaque. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Dental Plaque Imaging Methods
- What is being tested?
- Toothpastes
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 May 2021to 27 Aug 2021
- 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 35 years
- All sexes
- Adult
Study population: The study was performed with 30 adult male and female patients aged between 18-35, recruited from among the outpatients who visited the Marmara University, Faculty of Dentistry, Restorative Dentistry Department, agreed to the terms of the experiment, had a DMFT score 3 or lower, and had relatively even teeth arrangement. Among patients, those with orthodontic bracket placed, severe crowding of teeth not visually verified in the photograph, fixed or implant restoration installed, more than 3 DMFT score, and serious systemic diseases were excluded from the study.
Who may be able to join
- The volunteers between the ages of 18-35, No systemic disease, Teeth that do not contain hereditary, morphological, drug-induced structural changes, Not using orthodontic wires and appliances, Having a DMFT score of 3 and less than 3, Have not received antibiotic treatment in the last 6 weeks, Not using mouthwash in the last 6 weeks, Without dental calculus, Oral hygiene habits are similar to each other, University student or graduate, Thirty volunteers who were conscious of being able to understand and apply the guidelines set forth in the study were included.
Who cannot join
- Among volunteers, those with orthodontic bracket placed, severe crowding of teeth not visually verified in the photograph, fixed or implant restoration installed, more than 3 DMFT score, and serious systemic diseases were excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University Department of Restorative Dentistry
Istanbul
About this study
Official title: Assessment of Different Imaging Systems for Dental Plaque Scoring: an In-vivo Study
The aim of this study was to analyze the correlation between the dental plaque indices measured different imaging systems and conventional clinical indices that assess dental plaque. From among the patients who visited Marmara University, Faculty of Dentistry 30 adults between the age of 18-30, who had under 3 DMFT scores, were selected for full-mouth imaging. Digital dental photography, digital scanning system and fluorecam methods were used for taking intraoral images. The Turesky Modified Quigley Hein Plaque Index (TMQHPI) was scored both by the clinical examination method and on the images taken. The correlations between the clinical examinaton, digital photography, digital scanning system and fluorecam scores were analyzed. Maxillary and mandibulary anterior teeth's buccal surfaces were scored to TMQHPI after using disclosing agent.
Read the detailed description
The study was performed with 30 adult patients aged between 18-35, recruited from among the outpatients who visited the Marmara University, Faculty of Dentistry, Restorative Dentistry Department, agreed to the terms of the experiment, had a DMFT score 3 or lower, and had relatively even teeth arrangement. Among patients, those with orthodontic bracket placed, severe crowding of teeth not visually verified in the photograph, fixed or implant restoration installed, more than 3 DMFT score, and serious systemic diseases were excluded from the study.
In order to standardize the study, the volunteers were informed that they shouldn't eat any nutrients and do oral hygiene practices after dinner. Visualization of plaque samples formed in the mouth at least 8-12 hours between 08:30 and 10:00 a.m. in the morning and collecting dental plaque samples for microbiological examination were performed after the volunteers signed the informed consent form. The Turesky Modified Quigley Hein Plaque Index (TMQHPI) was scored both by the clinical examination method and on the images taken. The correlations between the manuel examinaton, digital photography, digital scanning system and fluorecam scores were analyzed. Maxillary and mandibulary anterior teeth's buccal surfaces were scored to TMQHPI after using disclosing agent. Using the standard toothbrush provided to the volunteers, they were asked to brush their teeth twice a day for 21 days with the recommended brushing method. After 21 days, dental plaque scoring and imaging procedure was repeated and dental plaque samples were collected again and placed in Eppendorf tubes. Eppendorf tubes were kept at -80 °C during the study. Bacterial changes in the samples taken on Day 0 and Day 21 were examined by Polymerase Chain Reaction (PCR) method in Marmara University Faculty of Medicine, Department of Clinical Microbiology. The levels in plaque samples of Streptococcus mutans, Lactobacillus acidophilus, Actinomyces viscosus, , Candida albicans, Staphylococcus aerus, were measured.
- Conditions
- Dental Plaque Imaging Methods
- Being tested
- Toothpastes
- Keywords
- dental plaque, dental photography, digital scanning system, fluorecam, Turesky Modified Quigley Hein Plaque Index
- Medical subject headings
- Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ToothpastesCombination product
Also called Signal Expert Protection, Colgate Hemp Seed Oil, Gumgumix
Signal Expert Protection: Conventional toothpaste including Sodium Lauryl Sulphate and fluoride.
Colgate Hemp Seed Oil: Herbal toothpaste including hemp seed oil and also fluoride.
Gumgumix: Herbal toothpaste including ginger extract (no fluoride).
| Study group | Role | What they receive |
|---|---|---|
| 1. Signal Expert Protection | After scoring clinically and with dental plaque imaging methods, Signal Expert Protection toothpaste was given to 10 volunteers. Receives: Combination Product: Toothpastes | |
| 2. Colgate Hemp Seed Oil | After scoring clinically and with dental plaque imaging methods, Colgate Hemp Seed Oil toothpaste was given to 10 volunteers. Receives: Combination Product: Toothpastes | |
| 3. Gumgumix | After scoring clinically and with dental plaque imaging methods, Gumgumix toothpaste was given to 10 volunteers. Receives: Combination Product: Toothpastes |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Dental plaque scoring clinically before staining agent
Dental plaque of the volunteer's anterior teeth were scored to Turesky Modified Quigley Hein Plaque Index
Measured: 15 minutes
2. Dental plaque scoring clinically after applying staining agent
Dental plaque of the volunteer's anterior teeth were scored to Turesky Modified Quigley Hein Plaque Index
Measured: 15 minutes
3.Dental plaque scoring after applying staining agent on the taken images with FluoreCam
Dental plaque of the volunteer's anterior teeth were scored on the images taken with FluoreCam to Turesky Modified Quigley Hein Plaque Index
Measured: 45 minutes
4. Dental plaque scoring after applying staining agent on the taken images with Digital Camera
Dental plaque of the volunteer's anterior teeth were scored on the images taken with FluoreCam to Turesky Modified Quigley Hein Plaque Index
Measured: 45 minutes
5. Dental plaque scoring after applying staining agent on the taken images with Intraoral Scanner
Dental plaque of the volunteer's anterior teeth were scored on the images taken with Intraoral Scanner to Turesky Modified Quigley Hein Plaque Index
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2022
- Study start17 May 2021
- Primary completion2 Jul 2021
- Study completion27 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Plaque Imaging MethodsStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05612009
- Sponsor's protocol ID
- S1s7s9s3
- Status last verified
- Nov 2022
- First submitted
- 3 Nov 2022
- Last updated
- 10 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Data will be shared after the publication of the article.
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Different Imaging Systems for Dental Plaque Scoring: an In-vivo Study
- ClinicalTrials.gov ID
- NCT05612009
- Acronym / sponsor ID
- S1s7s9s3
- Conditions
- Dental Plaque Imaging Methods
- Keywords
- dental plaque, dental photography, digital scanning system, fluorecam, Turesky Modified Quigley Hein Plaque Index
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 17 May 2021 (actual)
- Primary completion
- 2 Jul 2021 (actual)
- Study completion
- 27 Aug 2021 (actual)
- First posted
- 10 Nov 2022 (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.
The aim of this study was to analyze the correlation between the dental plaque indices measured different imaging systems and conventional clinical indices that assess dental plaque. From among the patients who visited Marmara University, Faculty of Dentistry 30 adults between the age of 18-30, who had under 3 DMFT scores, were selected for full-mouth imaging. Digital dental photography, digital scanning system and fluorecam methods were used for taking intraoral images. The Turesky Modified Quigley Hein Plaque Index (TMQHPI) was scored both by the clinical examination method and on the images taken. The correlations between the clinical examinaton, digital photography, digital scanning system and fluorecam scores were analyzed. Maxillary and mandibulary anterior teeth's buccal surfaces were scored to TMQHPI after using disclosing agent.
Detailed description
The study was performed with 30 adult patients aged between 18-35, recruited from among the outpatients who visited the Marmara University, Faculty of Dentistry, Restorative Dentistry Department, agreed to the terms of the experiment, had a DMFT score 3 or lower, and had relatively even teeth arrangement. Among patients, those with orthodontic bracket placed, severe crowding of teeth not visually verified in the photograph, fixed or implant restoration installed, more than 3 DMFT score, and serious systemic diseases were excluded from the study.
In order to standardize the study, the volunteers were informed that they shouldn't eat any nutrients and do oral hygiene practices after dinner. Visualization of plaque samples formed in the mouth at least 8-12 hours between 08:30 and 10:00 a.m. in the morning and collecting dental plaque samples for microbiological examination were performed after the volunteers signed the informed consent form. The Turesky Modified Quigley Hein Plaque Index (TMQHPI) was scored both by the clinical examination method and on the images taken. The correlations between the manuel examinaton, digital photography, digital scanning system and fluorecam scores were analyzed. Maxillary and mandibulary anterior teeth's buccal surfaces were scored to TMQHPI after using disclosing agent. Using the standard toothbrush provided to the volunteers, they were asked to brush their teeth twice a day for 21 days with the recommended brushing method. After 21 days, dental plaque scoring and imaging procedure was repeated and dental plaque samples were collected again and placed in Eppendorf tubes. Eppendorf tubes were kept at -80 °C during the study. Bacterial changes in the samples taken on Day 0 and Day 21 were examined by Polymerase Chain Reaction (PCR) method in Marmara University Faculty of Medicine, Department of Clinical Microbiology. The levels in plaque samples of Streptococcus mutans, Lactobacillus acidophilus, Actinomyces viscosus, , Candida albicans, Staphylococcus aerus, were measured.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1. Signal Expert Protection | – | Combination Product: ToothpastesAfter scoring clinically and with dental plaque imaging methods, Signal Expert Protection toothpaste was given to 10 volunteers. |
| 2. Colgate Hemp Seed Oil | – | Combination Product: ToothpastesAfter scoring clinically and with dental plaque imaging methods, Colgate Hemp Seed Oil toothpaste was given to 10 volunteers. |
| 3. Gumgumix | – | Combination Product: ToothpastesAfter scoring clinically and with dental plaque imaging methods, Gumgumix toothpaste was given to 10 volunteers. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Age groups
- Adult
- Study population
- The study was performed with 30 adult male and female patients aged between 18-35, recruited from among the outpatients who visited the Marmara University, Faculty of Dentistry, Restorative Dentistry Department, agreed to the terms of the experiment, had a DMFT score 3 or lower, and had relatively even teeth arrangement. Among patients, those with orthodontic bracket placed, severe crowding of teeth not visually verified in the photograph, fixed or implant restoration installed, more than 3 DMFT score, and serious systemic diseases were excluded from the study.
Key inclusion criteria (1 listed)
- The volunteers between the ages of 18-35, No systemic disease, Teeth that do not contain hereditary, morphological, drug-induced structural changes, Not using orthodontic wires and appliances, Having a DMFT score of 3 and less than 3, Have not received antibiotic treatment in the last 6 weeks, Not using mouthwash in the last 6 weeks, Without dental calculus, Oral hygiene habits are similar to each other, University student or graduate, Thirty volunteers who were conscious of being able to understand and apply the guidelines set forth in the study were included.
Key exclusion criteria (1 listed)
- Among volunteers, those with orthodontic bracket placed, severe crowding of teeth not visually verified in the photograph, fixed or implant restoration installed, more than 3 DMFT score, and serious systemic diseases were excluded from 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 |
|---|---|---|
| ToothpastesAlso: Signal Expert Protection, Colgate Hemp Seed Oil, GumgumixSignal Expert Protection: Conventional toothpaste including Sodium Lauryl Sulphate and fluoride. Colgate Hemp Seed Oil: Herbal toothpaste including hemp seed oil and also fluoride. Gumgumix: Herbal toothpaste including ginger extract (no fluoride). | Combination product | 1. Signal Expert Protection, 2. Colgate Hemp Seed Oil, 3. Gumgumix |
Primary outcome
1. Dental plaque scoring clinically before staining agent
Time frame: 15 minutes
Dental plaque of the volunteer's anterior teeth were scored to Turesky Modified Quigley Hein Plaque Index
2. Dental plaque scoring clinically after applying staining agent
Time frame: 15 minutes
Dental plaque of the volunteer's anterior teeth were scored to Turesky Modified Quigley Hein Plaque Index
3.Dental plaque scoring after applying staining agent on the taken images with FluoreCam
Time frame: 45 minutes
Dental plaque of the volunteer's anterior teeth were scored on the images taken with FluoreCam to Turesky Modified Quigley Hein Plaque Index
4. Dental plaque scoring after applying staining agent on the taken images with Digital Camera
Time frame: 45 minutes
Dental plaque of the volunteer's anterior teeth were scored on the images taken with FluoreCam to Turesky Modified Quigley Hein Plaque Index
5. Dental plaque scoring after applying staining agent on the taken images with Intraoral Scanner
Time frame: 1 hour
Dental plaque of the volunteer's anterior teeth were scored on the images taken with Intraoral Scanner to Turesky Modified Quigley Hein Plaque Index
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 10 Nov 2022.
- Individual participant dataSharing planned: Yes. Data will be shared after the publication of the article.
Related trials for Dental Plaque Imaging Methods
Not yet recruitingObservational study
3D Volumetric Plaque Assessment on Teeth, Composite Restorations, and Ceramic Veneers Using an Intraoral Scanner
Dental Plaque Accumulation, Oral Hygiene, Oral Health
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Imaging Methods, 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 10 Nov 2022. 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?
1. Dental plaque scoring clinically before staining agent (time frame: 15 minutes). The study lists 5 primary outcomes in all. 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 10 Nov 2022.