NCT06080672

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
124

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 20, 2023

Completed
22 days until next milestone

First Posted

Study publicly available on registry

October 12, 2023

Completed
7 months until next milestone

Study Start

First participant enrolled

May 14, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 14, 2024

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2024

Completed
Last Updated

May 2, 2025

Status Verified

April 1, 2025

Enrollment Period

3 months

First QC Date

September 20, 2023

Last Update Submit

April 29, 2025

Conditions

Keywords

Dental studentsPlaque indexGingival indexPlaque disclosing agents

Outcome Measures

Primary Outcomes (5)

  • 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.

    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

    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. 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.

    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. 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.

    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.

    30th minute of the first visit

Study Arms (2)

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.

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.

Other: Experimental: Group 1 (dental examination-training-tooth brushing) Experimental: Group 2 (dental examination-training-plaque disclosing-tooth brushing)

Interventions

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.

Group 1 (dental examination-training-tooth brushing)Group 2 (dental examination-training-plaque disclosing-tooth brushing)

Eligibility Criteria

Age20 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Systemically healthy
  • Being drug-free
  • Have at least twenty teeth in the mouth

You may not qualify if:

  • Smokers
  • Undergoing orthodontic treatment
  • Has pain or infection that prevent brushing
  • Pregnant/breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medipol University, Faculty of Dentistry, Department of Pedodontics

Istanbul, 34083, Turkey (Türkiye)

Location

Related Publications (5)

  • 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.

    PMID: 24582019BACKGROUND
  • da 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.

    PMID: 19089247BACKGROUND
  • Silva 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.

    PMID: 21365140BACKGROUND
  • Mensi 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.

    PMID: 32348624BACKGROUND
  • Montevecchi 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.

    PMID: 22371815BACKGROUND

Study Officials

  • Nilüfer Üstün, Ph.D.

    Medipol University

    PRINCIPAL INVESTIGATOR
  • Beyza Ballı Akgöl, Ph.D.

    Antalya Bilim University

    PRINCIPAL INVESTIGATOR
  • Merve Bayram, Ph.D.

    Medipol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

September 20, 2023

First Posted

October 12, 2023

Study Start

May 14, 2024

Primary Completion

August 14, 2024

Study Completion

August 30, 2024

Last Updated

May 2, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations