- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05612009
Assessment of Different Imaging Systems for Dental Plaque Scoring
Assessment of Different Imaging Systems for Dental Plaque Scoring: an In-vivo Study
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Istanbul, Turkey
- Marmara University Department of Restorative Dentistry
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
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.
Exclusion criteria:
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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1. Signal Expert Protection
After scoring clinically and with dental plaque imaging methods, Signal Expert Protection toothpaste was given to 10 volunteers.
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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).
Other Names:
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2. Colgate Hemp Seed Oil
After scoring clinically and with dental plaque imaging methods, Colgate Hemp Seed Oil toothpaste was given to 10 volunteers.
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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).
Other Names:
|
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3. Gumgumix
After scoring clinically and with dental plaque imaging methods, Gumgumix toothpaste was given to 10 volunteers.
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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).
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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1. Dental plaque scoring clinically before staining agent
Time Frame: 15 minutes
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Dental plaque of the volunteer's anterior teeth were scored to Turesky Modified Quigley Hein Plaque Index
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15 minutes
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2. Dental plaque scoring clinically after applying staining agent
Time Frame: 15 minutes
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Dental plaque of the volunteer's anterior teeth were scored to Turesky Modified Quigley Hein Plaque Index
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15 minutes
|
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3.Dental plaque scoring after applying staining agent on the taken images with FluoreCam
Time Frame: 45 minutes
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Dental plaque of the volunteer's anterior teeth were scored on the images taken with FluoreCam to Turesky Modified Quigley Hein Plaque Index
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45 minutes
|
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4. Dental plaque scoring after applying staining agent on the taken images with Digital Camera
Time Frame: 45 minutes
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Dental plaque of the volunteer's anterior teeth were scored on the images taken with FluoreCam to Turesky Modified Quigley Hein Plaque Index
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45 minutes
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5. Dental plaque scoring after applying staining agent on the taken images with Intraoral Scanner
Time Frame: 1 hour
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Dental plaque of the volunteer's anterior teeth were scored on the images taken with Intraoral Scanner to Turesky Modified Quigley Hein Plaque Index
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1 hour
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- S1s7s9s3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
- Informed Consent Form (ICF)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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