Periodontal IndexesNCT06080672
The Effect of Disclosing Dental Plaque on Plaque Index and Gingival Index in Faculty of Dentistry Students
A study testing Experimental: Group 1 (dental examination-training-tooth brushing) Experimental: Group 2 (dental examination-training-plaque disclosing-tooth brushing) in people with Periodontal Indexes and Oral Health, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
The hypothesis of this study is; using the tooth disclosing agents by individuals has a positive effect on oral care and as if it is an effective method in improving oral health. Read more about this study
- Who is it for?
- Ages 20 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Indexes, Oral Health
- What is being tested?
- Experimental: Group 1 (dental examination-training-tooth brushing) Experimental: Group 2 (dental examination-training-plaque disclosing-tooth brushing)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 May 2024to 30 Aug 2024
- Phase
- Interventional
- 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 20 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Systemically healthy
- Being drug-free
- Have at least twenty teeth in the mouth
Who cannot join
- Smokers
- Undergoing orthodontic treatment
- Has pain or infection that prevent brushing
- Pregnant/breastfeeding
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medipol University, Faculty of Dentistry, Department of Pedodontics
Istanbul, 34083
About this study
Official title: The Effect of Disclosing Dental Plaque on Plaque Index and Gingival Index in Istanbul Medipol University Faculty of Dentistry Students
The hypothesis of this study is; using the tooth disclosing agents by individuals has a positive effect on oral care and as if it is an effective method in improving oral health. Therefore, the aim of this study is to assess the effect of visual guidance of plaque disclosing agents on plaque removal efficacy for patients versus the group of patients evaluated without any tools.
Istanbul Medipol University Faculty of Dentistry 4th grade students are going to be invited to the study. The study will carry out with a total of 124 students. The students who are systemically healthy, drug-free, and at least 20 teeth in the mouth will be included in the study. Smokers, those undergoing orthodontic treatment, the presence of pain or infection that may prevent brushing, pregnant/breastfeeding students, and students who do not agree to participate in the study will not include to the study.
Read more
After the initial records (Plaque index and Gingival Index and DMFT- caries, missing teeth due to caries, filled teeth) were obtained, the students in the study will randomly divide into 2 groups:
Group 1; Control Group (n=62) After explaining the Modified Bass Technique and the use of dental floss/interface brush, students will be asked to brush their teeth.
Group 2; Test Group (n=62) After explaining the Modified Bass Technique and the use of dental floss/interface brush, the teeth will stain with a plaque disclosing agent, the plaque is going to be shown in the mirror and then the students will brush their teeth.
Post-operatively, periodontal parameters will be evaluated. Plaque index and gingival index will be measured immediately after brushing, 1 week, 1 months are going to be compared to baseline. A single investigator will make measurements of Gingival Index (GI, Löe and Sillness-1967) and Plaque Index (PI, Sillness and Löe-1964) using a Williams periodontal probe. Measurements will be obtained from 4 surfaces of all teeth (mesiobuccal, midbuccal, distobuccal, midlingual) except third molar teeth, and the values obtained will be summed and averaged, and the average of one tooth. Then, these values will be summed up and averaged, and the mean PI and GI of the individual will be obtained. The outcomes of the two groups will be evaluated by statistical analysis.
Read the detailed description
The study will be carried out in Istanbul Medipol University Department of Pedodontics, period between October 2023- January 2024. Ethical approval for the study was received from Istanbul Medipol University Ethics Committee. (REF: E-10840098-772.02-2361). The students who agreed to participate in the study will be informed about the study and the written informed consents will be obtained from all participants included in the study.
At the end of the study, 124 students whose measurements were completed will be included in the research. A randomization list was generated using online software (http://www.graphpad.com/quickcalcs/index.cfm), where students enrolled on the study were randomized into 2 groups with an allocation ratio of 1:1. The random allocation sequence was generated by an independent researcher; thus, the operator and observer were blinded to the assignment of the study participants to the groups as follows:
Group 1: Students, whose first records (plaque index, gingival index) are taken after the examination by the periodontology specialist, will be taught how to brush their teeth with the Modified Bass Technique and how to use dental floss/interdental brush. Students will then be asked to brush their teeth.
Group 2: The students, whose initial records (plaque index, gingival index) are taken after the examination by the periodontology specialist, will be taught how to brush their teeth with the Modified Bass Technique and how to use dental floss/interdental brush. After staining the teeth with a plaque disclosing agent, they will be shown in the mirror. Then the students will then be asked to brush their teeth.
Study Design This randomized clinical study will last in three months. According to data from the previous studies, the desired sample size (n=124) was calculated. Among the 204 students who were examined in the beginning, 124 students who met the inclusion criteria will be included in the study to be protected from dropouts.
In the beginning, students are going to fill out an examination form consisting of questions about attitudes of their oral and dental health and the demographic data of the study group. Examination forms consisted of; name-surname, birthdate, examination date, gender, tooth brushing habits (yes or no, and how often they brush their teeth), the use of dental floss and/or an interdental (interface) brush, and how often they use them, the use of mouthwash and/or mouth spray, the last time of they visited a dentist, bleeding of their gums (yes/no). Then, the students will be examined and their DMFT index (decayed, filled, and missing teeth), baseline plaque index and gingival index measurements will be recorded. The students will randomly divide into two groups. All students will be trained about toothbrushing by Modified Bass Technique and the use of dental floss/interface brush by the video presentation and demonstrating with models from the same instructer. Commercially available standard toothpastes will be distributed to students. The students in the control group will be asked to brush their teeth with the technique taught. The teeth of the students in the second group, which is the test group, to stain the teeth Mira 2-tone Solution (Hager\&Werken) will be used to visualize dental plaque. After the staining, the students will rinse their mouths with water and the stained tooth surfaces will be shown with the help of hand mirrors. Then the second groups students will brush their teeth with Modified Bass Technique and only the plaque index will be measured again. One week later, the students will be called for control again, and plaque index and gingival index measurements will be repeated in the test group after plaque disclosing and in the control group without disclosing. At the end of one month, the measurements will be repeated in both groups and the data will be recorded.
Gingival Index (GI, Löe and Sillness-1967) and Plaque Index (PI, Sillness and Löe-1964) measurements will be done by a single investigator using a Williams periodontal probe. Measurements will be obtained from 4 surfaces of all teeth (mesiobuccal, midbuccal, distobuccal, midlingual) except third molars, and the values obtained will be summed and averaged, and the average of one tooth; Then, these values will be summed up and averaged, and the mean PI and GI of the individual will be obtained.
The distribution of variables will be analyzed using the Kolmogorov-Smirnov test. Student's t-test and chi-square test will be used to compare the quantitative and qualitative data of the two groups. Spearman's correlation coefficient (R) will be used to evaluate relationships between periodontal status data (PI, GI, DMFT).
- Conditions
- Periodontal Indexes, Oral Health
- Being tested
- Experimental: Group 1 (dental examination-training-tooth brushing) Experimental: Group 2 (dental examination-training-plaque disclosing-tooth brushing)
- Keywords
- Dental students, Plaque index, Gingival index, Plaque disclosing agents
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Group 1 (dental examination-training-tooth brushing) Experimental: Group 2 (dental examination-training-plaque disclosing-tooth brushing)Other
All participants will be examined and their decay, filling and extracted teeth, plaque index and gingival index measurements will be recorded. Plaque disclosing will be applied to Group 2 after brushing training.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (dental examination-training-tooth brushing) | Experimental | Students, whose first records (plaque index, gingival index) are taken after the examination by the periodontology specialist, will be taught how to brush their teeth with the Modified Bass Technique and how to use dental floss/interdental brush. Students will then be asked to brush their teeth. Receives: Other: Experimental: Group 1 (dental examination-training-tooth brushing) Experimental: Group 2 (dental examination-training-plaque disclosing-tooth brushing) |
| Group 2 (dental examination-training-plaque disclosing-tooth brushing) | Experimental | The students, whose initial records (plaque index, gingival index) are taken after the examination by the periodontology specialist, will be taught how to brush their teeth with the Modified Bass Technique and how to use dental floss/interdental brush. After staining the teeth with a plaque disclosing agent, they will be shown in the mirror. Then the students will then be asked to brush their teeth. Receives: Other: Experimental: Group 1 (dental examination-training-tooth brushing) Experimental: Group 2 (dental examination-training-plaque disclosing-tooth brushing) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Filling examination forms
The form containing questions about the study group's attitudes towards oral and dental health and their demographic data is filled out by the participants.
Measured: The first 10 minutes of the first visit
Dental examination
Oral and dental examination will be done by a specialist periodontist, and DMFT index (total number of decayed, filled, and missing teeth) will be recorded
Measured: Immediately after the students filled the examination forms at the first visit
Plaque Index (PI, Sillness and Löe-1964) measurements
Measurements will be done by a single investigator using a Williams periodontal probe. Measurements will be obtained from 4 surfaces of all teeth (mesiobuccal, midbuccal, distobuccal, midlingual) except third molars, and the values obtained will be summed and averaged, and the average of one tooth; Then, these values will be summed up and averaged, and the mean PI of the individual will be obtained. The PI which is going to be used to determine the oral hygiene level of the individuals included in the study will be evaluated as follows:
0: No bacterial plaque on the tooth surface.
- There is plaque in the form of film and can be seen with the help of a probe.
- There is moderate soft attachment visible to the naked eye.
- There is a visible dense soft appendage filling the gingival sulcus on the tooth surface.
Measured: During the dental examination procedure
Gingival Index (GI, Löe and Sillness-1967) measurements
Measurements will be done by a single investigator using a Williams periodontal probe. Measurements will be obtained from 4 surfaces of all teeth (mesiobuccal, midbuccal, distobuccal, midlingual) except third molars, and the values obtained will be summed and averaged, and the average of one tooth; Then, these values will be summed up and averaged, and the mean GI of the individual will be obtained.
GI will be evaluated according to the following criteria:
0: Healthy gingiva.
- There is mild inflammation, discoloration and edema, no bleeding on probing.
- Moderate inflammation, marked redness, edema, and bleeding on probing.
- Severe inflammation, prominent redness and edema, ulceration, spontaneous bleeding tendency.
Measured: During the dental examination procedure
Green and Vermillion Oral Hygiene Index-Simplified
In the second group, to stain the teeth Mira 2-tone Solution (Hager\&Werken) will be used to visualize dental plaque. The amount of plaque will be measured by staining method from different surfaces of six teeth, two from the front area and four from the back area. 2 drops of Mira-2-tone plaque staining solution will be placed in plastic containers and be applied to the teeth with a brush. Measurements will be done from the buccal surfaces of teeth 16 and 26, the lingual surfaces of teeth 36 and 46, and the labial surfaces of teeth 11 and 31. The amount of plaque will be graded with 4 separate scores from 0 to 3, depending on the size of the surface area stained with the staining solution. The index will be calculated by dividing the total values by the number of surfaces.
Measured: 30th minute of the first visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study start14 May 2024
- Primary completion14 Aug 2024
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Periodontal IndexesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group 1: Students, whose first records (plaque index, gingival index) are taken after the examination by the periodontology specialist, will be taught how to brush their teeth with the Modified Bass Technique and how to use dental floss/interdental brush. Students will then be asked to brush their teeth. Group 2: The students, whose initial records (plaque index, gingival index) are taken after the examination by the periodontology specialist, will be taught how to brush their teeth with the Modified Bass Technique and how to use dental floss/interdental brush. After staining the teeth with a plaque disclosing agent, they will be shown in the mirror. Then the students will then be asked to brush their teeth.
- Masking
- None (open label)
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nilüfer Üstün, Istanbul Medipol University Hospital
- Investigators
- Nilüfer Üstün, Ph.D., Principal investigator, Medipol UniversityBeyza Ballı Akgöl, Ph.D., Principal investigator, Antalya Bilim UniversityMerve Bayram, Ph.D., Principal investigator, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06080672
- Sponsor's protocol ID
- E-10840098-772.02-2361
- Status last verified
- Apr 2025
- First submitted
- 20 Sep 2023
- Last updated
- 2 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Peng Y, Wu R, Qu W, Wu W, Chen J, Fang J, Chen Y, Farella M, Mei L. Effect of visual method vs plaque disclosure in enhancing oral hygiene in adolescents and young adults: a single-blind randomized controlled trial. Am J Orthod Dentofacial Orthop. 2014 Mar;145(3):280-6. doi: 10.1016/j.ajodo.2013.10.021.
PubMed 24582019da Silva CH, Paranhos Hde F. Efficacy of biofilm disclosing agent and of three brushes in the control of complete denture cleansing. J Appl Oral Sci. 2006 Dec;14(6):454-9. doi: 10.1590/s1678-77572006000600012.
PubMed 19089247Silva DD, Goncalo Cda S, Sousa Mda L, Wada RS. Aggregation of plaque disclosing agent in a dentifrice. J Appl Oral Sci. 2004 Jun;12(2):154-8. doi: 10.1590/s1678-77572004000200014.
PubMed 21365140Mensi M, Scotti E, Sordillo A, Agosti R, Calza S. Plaque disclosing agent as a guide for professional biofilm removal: A randomized controlled clinical trial. Int J Dent Hyg. 2020 Aug;18(3):285-294. doi: 10.1111/idh.12442. Epub 2020 May 26.
PubMed 32348624Montevecchi M, Checchi V, Gatto MR, Klein S, Checchi L. The use of a disclosing agent during resective periodontal surgery for improved removal of biofilm. Open Dent J. 2012;6:46-50. doi: 10.2174/1874210601206010046. Epub 2012 Feb 6.
PubMed 22371815Balli Akgol B, Bayram M, Ustun N, Aksaka N. Effect of plaque-disclosing agents on biofilm removal: single-center randomized trial in fourth-year dental students. Head Face Med. 2026 Mar 6;22(1):31. doi: 10.1186/s13005-026-00596-z.
PubMed 41792751
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Disclosing Dental Plaque on Plaque Index and Gingival Index in Istanbul Medipol University Faculty of Dentistry Students
- ClinicalTrials.gov ID
- NCT06080672
- Acronym / sponsor ID
- E-10840098-772.02-2361
- Conditions
- Periodontal Indexes, Oral Health
- Keywords
- Dental students, Plaque index, Gingival index, Plaque disclosing agents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 14 May 2024 (actual)
- Primary completion
- 14 Aug 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 12 Oct 2023 (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 hypothesis of this study is; using the tooth disclosing agents by individuals has a positive effect on oral care and as if it is an effective method in improving oral health. Therefore, the aim of this study is to assess the effect of visual guidance of plaque disclosing agents on plaque removal efficacy for patients versus the group of patients evaluated without any tools.
Istanbul Medipol University Faculty of Dentistry 4th grade students are going to be invited to the study. The study will carry out with a total of 124 students. The students who are systemically healthy, drug-free, and at least 20 teeth in the mouth will be included in the study. Smokers, those undergoing orthodontic treatment, the presence of pain or infection that may prevent brushing, pregnant/breastfeeding students, and students who do not agree to participate in the study will not include to the study.
After the initial records (Plaque index and Gingival Index and DMFT- caries, missing teeth due to caries, filled teeth) were obtained, the students in the study will randomly divide into 2 groups:
Group 1; Control Group (n=62) After explaining the Modified Bass Technique and the use of dental floss/interface brush, students will be asked to brush their teeth.
Group 2; Test Group (n=62) After explaining the Modified Bass Technique and the use of dental floss/interface brush, the teeth will stain with a plaque disclosing agent, the plaque is going to be shown in the mirror and then the students will brush their teeth.
Post-operatively, periodontal parameters will be evaluated. Plaque index and gingival index will be measured immediately after brushing, 1 week, 1 months are going to be compared to baseline. A single investigator will make measurements of Gingival Index (GI, Löe and Sillness-1967) and Plaque Index (PI, Sillness and Löe-1964) using a Williams periodontal probe. Measurements will be obtained from 4 surfaces of all teeth (mesiobuccal, midbuccal, distobuccal, midlingual) except third molar teeth, and the values obtained will be summed and averaged, and the average of one tooth. Then, these values will be summed up and averaged, and the mean PI and GI of the individual will be obtained. The outcomes of the two groups will be evaluated by statistical analysis.
Detailed description
The study will be carried out in Istanbul Medipol University Department of Pedodontics, period between October 2023- January 2024. Ethical approval for the study was received from Istanbul Medipol University Ethics Committee. (REF: E-10840098-772.02-2361). The students who agreed to participate in the study will be informed about the study and the written informed consents will be obtained from all participants included in the study.
At the end of the study, 124 students whose measurements were completed will be included in the research. A randomization list was generated using online software (http://www.graphpad.com/quickcalcs/index.cfm), where students enrolled on the study were randomized into 2 groups with an allocation ratio of 1:1. The random allocation sequence was generated by an independent researcher; thus, the operator and observer were blinded to the assignment of the study participants to the groups as follows:
Group 1: Students, whose first records (plaque index, gingival index) are taken after the examination by the periodontology specialist, will be taught how to brush their teeth with the Modified Bass Technique and how to use dental floss/interdental brush. Students will then be asked to brush their teeth.
Group 2: The students, whose initial records (plaque index, gingival index) are taken after the examination by the periodontology specialist, will be taught how to brush their teeth with the Modified Bass Technique and how to use dental floss/interdental brush. After staining the teeth with a plaque disclosing agent, they will be shown in the mirror. Then the students will then be asked to brush their teeth.
Study Design This randomized clinical study will last in three months. According to data from the previous studies, the desired sample size (n=124) was calculated. Among the 204 students who were examined in the beginning, 124 students who met the inclusion criteria will be included in the study to be protected from dropouts.
In the beginning, students are going to fill out an examination form consisting of questions about attitudes of their oral and dental health and the demographic data of the study group. Examination forms consisted of; name-surname, birthdate, examination date, gender, tooth brushing habits (yes or no, and how often they brush their teeth), the use of dental floss and/or an interdental (interface) brush, and how often they use them, the use of mouthwash and/or mouth spray, the last time of they visited a dentist, bleeding of their gums (yes/no). Then, the students will be examined and their DMFT index (decayed, filled, and missing teeth), baseline plaque index and gingival index measurements will be recorded. The students will randomly divide into two groups. All students will be trained about toothbrushing by Modified Bass Technique and the use of dental floss/interface brush by the video presentation and demonstrating with models from the same instructer. Commercially available standard toothpastes will be distributed to students. The students in the control group will be asked to brush their teeth with the technique taught. The teeth of the students in the second group, which is the test group, to stain the teeth Mira 2-tone Solution (Hager\&Werken) will be used to visualize dental plaque. After the staining, the students will rinse their mouths with water and the stained tooth surfaces will be shown with the help of hand mirrors. Then the second groups students will brush their teeth with Modified Bass Technique and only the plaque index will be measured again. One week later, the students will be called for control again, and plaque index and gingival index measurements will be repeated in the test group after plaque disclosing and in the control group without disclosing. At the end of one month, the measurements will be repeated in both groups and the data will be recorded.
Gingival Index (GI, Löe and Sillness-1967) and Plaque Index (PI, Sillness and Löe-1964) measurements will be done by a single investigator using a Williams periodontal probe. Measurements will be obtained from 4 surfaces of all teeth (mesiobuccal, midbuccal, distobuccal, midlingual) except third molars, and the values obtained will be summed and averaged, and the average of one tooth; Then, these values will be summed up and averaged, and the mean PI and GI of the individual will be obtained.
The distribution of variables will be analyzed using the Kolmogorov-Smirnov test. Student's t-test and chi-square test will be used to compare the quantitative and qualitative data of the two groups. Spearman's correlation coefficient (R) will be used to evaluate relationships between periodontal status data (PI, GI, DMFT).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Group 1: Students, whose first records (plaque index, gingival index) are taken after the examination by the periodontology specialist, will be taught how to brush their teeth with the Modified Bass Technique and how to use dental floss/interdental brush. Students will then be asked to brush their teeth. Group 2: The students, whose initial records (plaque index, gingival index) are taken after the examination by the periodontology specialist, will be taught how to brush their teeth with the Modified Bass Technique and how to use dental floss/interdental brush. After staining the teeth with a plaque disclosing agent, they will be shown in the mirror. Then the students will then be asked to brush their teeth.
| Arm | Type | Receives |
|---|---|---|
| Group 1 (dental examination-training-tooth brushing) | Experimental | Other: Experimental: Group 1 (dental examination-training-tooth brushing) Experimental: Group 2 (dental examination-training-plaque disclosing-tooth brushing)Students, whose first records (plaque index, gingival index) are taken after the examination by the periodontology specialist, will be taught how to brush their teeth with the Modified Bass Technique and how to use dental floss/interdental brush. Students will then be asked to brush their teeth. |
| Group 2 (dental examination-training-plaque disclosing-tooth brushing) | Experimental | Other: Experimental: Group 1 (dental examination-training-tooth brushing) Experimental: Group 2 (dental examination-training-plaque disclosing-tooth brushing)The students, whose initial records (plaque index, gingival index) are taken after the examination by the periodontology specialist, will be taught how to brush their teeth with the Modified Bass Technique and how to use dental floss/interdental brush. After staining the teeth with a plaque disclosing agent, they will be shown in the mirror. Then the students will then be asked to brush their teeth. |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Systemically healthy
- Being drug-free
- Have at least twenty teeth in the mouth
Key exclusion criteria (4 listed)
- Smokers
- Undergoing orthodontic treatment
- Has pain or infection that prevent brushing
- Pregnant/breastfeeding
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 |
|---|---|---|
| Experimental: Group 1 (dental examination-training-tooth brushing) Experimental: Group 2 (dental examination-training-plaque disclosing-tooth brushing)All participants will be examined and their decay, filling and extracted teeth, plaque index and gingival index measurements will be recorded. Plaque disclosing will be applied to Group 2 after brushing training. | Other | Group 1 (dental examination-training-tooth brushing), Group 2 (dental examination-training-plaque disclosing-tooth brushing) |
Primary outcome
Filling examination forms
Time frame: The first 10 minutes of the first visit
The form containing questions about the study group's attitudes towards oral and dental health and their demographic data is filled out by the participants.
Dental examination
Time frame: Immediately after the students filled the examination forms at the first visit
Oral and dental examination will be done by a specialist periodontist, and DMFT index (total number of decayed, filled, and missing teeth) will be recorded
Plaque Index (PI, Sillness and Löe-1964) measurements
Time frame: During the dental examination procedure
Measurements will be done by a single investigator using a Williams periodontal probe. Measurements will be obtained from 4 surfaces of all teeth (mesiobuccal, midbuccal, distobuccal, midlingual) except third molars, and the values obtained will be summed and averaged, and the average of one tooth; Then, these values will be summed up and averaged, and the mean PI of the individual will be obtained. The PI which is going to be used to determine the oral hygiene level of the individuals included in the study will be evaluated as follows: 0: No bacterial plaque on the tooth surface. 1. There is plaque in the form of film and can be seen with the help of a probe. 2. There is moderate soft attachment visible to the naked eye. 3. There is a visible dense soft appendage filling the gingival sulcus on the tooth surface.
Gingival Index (GI, Löe and Sillness-1967) measurements
Time frame: During the dental examination procedure
Measurements will be done by a single investigator using a Williams periodontal probe. Measurements will be obtained from 4 surfaces of all teeth (mesiobuccal, midbuccal, distobuccal, midlingual) except third molars, and the values obtained will be summed and averaged, and the average of one tooth; Then, these values will be summed up and averaged, and the mean GI of the individual will be obtained. GI will be evaluated according to the following criteria: 0: Healthy gingiva. 1. There is mild inflammation, discoloration and edema, no bleeding on probing. 2. Moderate inflammation, marked redness, edema, and bleeding on probing. 3. Severe inflammation, prominent redness and edema, ulceration, spontaneous bleeding tendency.
Green and Vermillion Oral Hygiene Index-Simplified
Time frame: 30th minute of the first visit
In the second group, to stain the teeth Mira 2-tone Solution (Hager\&Werken) will be used to visualize dental plaque. The amount of plaque will be measured by staining method from different surfaces of six teeth, two from the front area and four from the back area. 2 drops of Mira-2-tone plaque staining solution will be placed in plastic containers and be applied to the teeth with a brush. Measurements will be done from the buccal surfaces of teeth 16 and 26, the lingual surfaces of teeth 36 and 46, and the labial surfaces of teeth 11 and 31. The amount of plaque will be graded with 4 separate scores from 0 to 3, depending on the size of the surface area stained with the staining solution. The index will be calculated by dividing the total values by the number of surfaces.
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 2 May 2025.
- Background: PubMed 24582019Peng Y, Wu R, Qu W, Wu W, Chen J, Fang J, Chen Y, Farella M, Mei L. Effect of visual method vs plaque disclosure in enhancing oral hygiene in adolescents and young adults: a single-blind randomized controlled trial. Am J Orthod Dentofacial Orthop. 2014 Mar;145(3):280-6. doi: 10.1016/j.ajodo.2013.10.021.
- Background: PubMed 19089247da Silva CH, Paranhos Hde F. Efficacy of biofilm disclosing agent and of three brushes in the control of complete denture cleansing. J Appl Oral Sci. 2006 Dec;14(6):454-9. doi: 10.1590/s1678-77572006000600012.
- Background: PubMed 21365140Silva DD, Goncalo Cda S, Sousa Mda L, Wada RS. Aggregation of plaque disclosing agent in a dentifrice. J Appl Oral Sci. 2004 Jun;12(2):154-8. doi: 10.1590/s1678-77572004000200014.
- Background: PubMed 32348624Mensi M, Scotti E, Sordillo A, Agosti R, Calza S. Plaque disclosing agent as a guide for professional biofilm removal: A randomized controlled clinical trial. Int J Dent Hyg. 2020 Aug;18(3):285-294. doi: 10.1111/idh.12442. Epub 2020 May 26.
- Background: PubMed 22371815Montevecchi M, Checchi V, Gatto MR, Klein S, Checchi L. The use of a disclosing agent during resective periodontal surgery for improved removal of biofilm. Open Dent J. 2012;6:46-50. doi: 10.2174/1874210601206010046. Epub 2012 Feb 6.
- Derived from this study: PubMed 41792751Balli Akgol B, Bayram M, Ustun N, Aksaka N. Effect of plaque-disclosing agents on biofilm removal: single-center randomized trial in fourth-year dental students. Head Face Med. 2026 Mar 6;22(1):31. doi: 10.1186/s13005-026-00596-z.
- Individual participant dataSharing planned: No
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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.
Nilüfer Üstün, Ph.D. principal investigator
Medipol University
Beyza Ballı Akgöl, Ph.D. principal investigator
Antalya Bilim University
Merve Bayram, Ph.D. principal investigator
Medipol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: Group 1 (dental examination-training-tooth brushing) Experimental: Group 2 (dental examination-training-plaque disclosing-tooth brushing) in people with Periodontal Indexes and Oral Health, run by Istanbul Medipol University Hospital 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 3 inclusion and 4 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 2 May 2025. 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?
Filling examination forms (time frame: The first 10 minutes of the first visit). 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?
On the ClinicalTrials.gov record for NCT06080672, which also lists 6 linked publications.
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 2 May 2025.