Digital Quantification of Dental Plaque Based on Intraoral Scanner Images
Conditions: Dental Plaque (Diagnosis), Dental Plaque Imaging Methods, Dental Plaque, Gingivitis, Periodontal Disease
Sponsor: University of Guarulhos

 
 
 
 
 
 
 
Digital quantification of dental plaque based on 
intraoral scanner images 
 
 
 
 
Ethical committee approval number: CAAE 85446624.8.0000.5506 
Approved on March 25, 2025 
 
 

SUMMARY 
 
 
1. 
INTRODUCTION: ................................................................. 4 
2. 
Hypothesis ............................................................................ 5 
3. 
OBJECTIVES: ...................................................................... 5 
4. 
METHODOLOGY:................................................................. 6 
4.1. Ethical considerations ........................................................... 6 
4.2. Study design ......................................................................... 6 
4.3. Patient selection ................................................................... 7 
4.4. Inclusion Criteria: .................................................................. 7 
4.5. Exclusion Criteria: ................................................................. 8 
4.6. Clinical procedures ............................................................... 8 
4.7. Image analysis ...................................................................... 9 
4.8. Statistical analysis Plan (SAP) .............................................. 9 
4.9. Risks ..................................................................................... 9 
4.10. Benefits ............................................................................... 10 
4.11. Criteria for suspending or terminating the search ............. 10 
5. 
SCHEDULE ........................................................................ 11 
6. 
REFERENCES ................................................................... 11 
7. 
Appendix 1: Ethical committee Approval ............................. 14 
8. 
Appendix 2: Informed Consent ........................................... 19 
 
 
 

Abstract 
Objective: To develop and validate a digital method for dental biofilm 
quantification based on three-dimensional images obtained by intraoral scanner, 
comparing its accuracy with traditional clinical assessment methods. 
Methods: A prospective, evaluator-blinded clinical study including 20 participants 
(18-65 years) with at least 20 natural teeth and visible plaque index >20%. 
Participants will be evaluated at three time points in a single session: initial 
scanning (T0), after biofilm disclosure (T1), and after supervised toothbrushing 
(T2). Digital analysis will be performed using Geomagic Control X software, 
calculating the percentage of surface area covered by plaque. Data will be 
analyzed using Spearman correlation and repeated measures ANOVA or 
Friedman test. 
Expected Results: This digital method will provide a more objective and precise 
assessment of dental biofilm, overcoming limitations of conventional methods. 
Conclusion: The validation of this new digital approach could significantly 
contribute to advancing clinical practices and research in preventive dentistry. 
 
Keywords: 
Dental Biofilm; Intraoral Scanner; Digital Diagnosis; Digital 
Methodology; Preventive Dentistry. 
 
 

1. INTRODUCTION: 
 
Plaque is the main etiological factor of periodontal diseases(Abdulkareem 
et al., 2023) Plaque is constantly present around the tooth near the gingival 
sulcus and elicits an immune-inflammatory response from the host. This 
inflammation remains confined to the gums, and if the local factor (Biofilm) is not 
resolved with home care, such as mechanical or chemical biofilm control 
measures, it will develop and result in gingivitis and periodontitis (Kinane et al., 
2017; Könönen et al., 2019). Accurate assessment of biofilm quantity and 
distribution is critical for both clinical diagnosis and monitoring and preventive 
dentistry research(Pretty et al., 2005). 
Traditionally, biofilm quantification is performed by visual indices, such as 
the Quigley-Hein Plaque Index modified by Turesky(Turesky et al., 1970). 
Although widely used, these methods have important limitations, including the 
subjectivity of the assessment, the need for calibration between examiners, and 
the difficulty of detecting small changes in plaque quantity(Carter et al., 2004). 
In recent years, the advancement of digital technologies in dentistry has 
provided new possibilities for the quantitative evaluation of dental biofilm. The 
use of digital photographs and computerized image analysis has shown 
promising results, allowing for a more objective and accurate quantification of 
dental plaque(Guo et al., 2024; Joseph et al., 2015; You et al., 2020). However, 
these techniques are still limited by the two-dimensional nature of the images, 
which do not fully capture the three-dimensional complexity of tooth 
surfaces(Giese-Kraft et al., 2022). 
Intraoral scanners, initially developed for applications in restorative 
dentistry and orthodontics, have gained ground as diagnostic tools and clinical 
documentation(Mangano et al., 2017). These devices are capable of capturing 
detailed three-dimensional images of the oral cavity, including information about 
the color and texture of tooth surfaces(Giese-Kraft et al., 2022; Zimmermann et 
al., 2015). Recent studies have explored the potential of intraoral scanners for 
the detection and quantification of dental plaque, showing promising results in 
terms of accuracy and reproducibility(Guo et al., 2024; Rikvold et al., 2023). 

The development of a digital method for biofilm quantification based on 
intraoral scanner images represents an innovative approach that can overcome 
many of the limitations of conventional methods. In addition to providing a more 
objective and accurate assessment, this method has the potential to facilitate the 
storage and longitudinal comparison of data, as well as allow for more 
sophisticated analyses of plaque distribution and accumulation patterns(Giese-
Kraft et al., 2022; Jung et al., 2022). 
In this context, the present study aims to develop and validate a new digital 
method for quantification of dental plaque using three-dimensional images 
obtained by intraoral scanners. It is hoped that this approach can contribute to 
the advancement of clinical and research practices in preventive dentistry, 
offering a more accurate and objective tool for the evaluation of dental biofilm. 
 
2.  Hypothesis 
The digital quantification method of dental biofilm through three-
dimensional images obtained by intraoral scanner demonstrates non-inferiority in 
measurement when compared to the traditional method of visual clinical 
assessment with plaque disclosing solution, being able to detect and document 
the presence and distribution of biofilm on dental surfaces 
3. OBJECTIVES: 
Primary objective: 
• To develop and validate a digital method for biofilm quantification based 
on three-dimensional images obtained by intraoral scanner. 
 
Secondary objectives: 
• To compare the accuracy and precision of the proposed digital method 
with the reference method of clinical assessment of dental biofilm. 
• To investigate the capability of the digital method to detect changes in 
plaque quantity after toothbrushing. 

• To analyze biofilm distribution patterns on dental surfaces using three-
dimensional images obtained by the intraoral scanner. 
4. METHODOLOGY: 
4.1. Ethical considerations 
This research project will be carried out at the Center for Clinical Studies of 
Univeritas UnG, in accordance with the resolution of the National Health Council 
and only after approval by the Research Ethics Committee of the University of 
Guarulhos. All subjects will be informed about the objectives and characteristics 
of the study and will be required to sign the Informed Consent Form (ICF) before 
being included. Privacy, secrecy and confidentiality policies will be strictly 
enforced in the project. All data, digital files, and images collected will be encoded 
with identification numbers, and images from the intraoral scanner will be 
anonymized prior to storage. Access to the data will be controlled by password 
and limited to authorized researchers. The data will be kept for a period of 5 years 
after the end of the research, and the dissemination of the results at scientific 
events, congresses and scientific articles will ensure the anonymity of the 
participants. 
4.2. Study design 
A prospective clinical study with clinical evaluation and blinded to the evaluator 
will be conducted.  
Primary Outcome: 
• Correlation between the percentage of dental surface area covered by 
biofilm quantified by the digital method (intraoral scanner) and the plaque 
index obtained by the traditional clinical method (Quigley-Hein Plaque 
Index modified by Turesky). 
Secondary Outcome: 
• Ability of the digital method to detect changes in the amount of biofilm, 
evaluated by the percentage difference in area covered between T0 
(initial), T1 (after disclosure) and T2 (after professional brushing). 
• Time required to perform the digital analysis compared to the evaluation 
time by the traditional method. 

• Technical feasibility of the scanning protocol for biofilm quantification in a 
clinical setting. 
• Tooth surface topographic analysis for between T0 (initial), and T2 (after 
professional brushing) 
• Fluorescence imaging capabilities: Detection sensitivity for plaque, 
correlation 
with 
clinical 
findings, 
reproducibility 
of 
fluorescence 
measurements. 
• Plaque volume/thickness changes analysis: utilize 3Shape’s alignment of 
sequential scans to generate difference maps, enabling the visualization 
and evaluation of plaque changes (e.g., before and after cleaning), finding 
appropriate metrics for quantification, and correlating those with other 
features, such as disclosing agent color and fluorescence.  
• Dental biofilm detection through intraoral photographs with different filters 
 
4.3. Patient selection 
20 participants of both sexes, aged between 18 and 65 years, will be selected, 
the dissemination of recruitment will be carried out through different 
communication channels, including informative posters distributed in the dental 
clinics of UnG, digital dissemination on the university's official website and its 
institutional social networks, direct invitation to patients who are on the waiting 
list of the periodontics clinic and dissemination by the professors of the 
undergraduate and graduate clinics.  All promotional material will contain clear 
information about the inclusion and exclusion criteria, as well as the contacts for 
scheduling the initial screening and the ethics committee approval number. The 
sample size calculation was performed following a previous study(Del Rey et al., 
2023), considering a power of 80% and a significance level of 5%. 
 
4.4. Inclusion Criteria: 
• Presence of at least 20 natural teeth 
• Visible plaque index > 20% at initial assessment 

4.5. Exclusion Criteria: 
• Use of fixed orthodontic appliances 
• Presence of extensive restorations or fixed dentures on the anterior teeth 
• Systemic conditions that interfere with the formation of dental biofilm 
• Use of medications that alter salivary flow 
4.6. Clinical procedures 
The clinical evaluations, scans, photos, and the supervised tooth brushing will be 
carried out by a team composed of 3 graduate students and professors from UnG, 
specialized in Periodontics and/or implantology. To ensure accuracy, a 
theoretical-practical training on the Turesky Plaque Index will be carried out, 
followed by intra-examiner calibration in 5 patients who did not participate in the 
study, with an accepted Kappa coefficient above 0.8. The study will be conducted 
according to the following visit schedule: 
Visit 
Procedures 
Details 
Visit 1 
• Project explanation 
• General oral evaluation 
• Informed consent signing 
• Instructions for 24-hour no-brushing 
period 
• Participants will receive detailed 
information about the study 
protocol 
• A preliminary oral assessment 
will be performed 
• Instructions will be provided for 
the 24-hour no-brushing period 
before Visit 2 
Visit 2 
(Experimental 
Session) 
Phase 1 - Initial Assessment (T0) 
• Initial intraoral scanning 
• Standardized intraoral photographs 
Phase 2 - After Plaque Disclosure (T1) 
• Application of plaque disclosing solution 
• Intraoral scanning with disclosed biofilm 
• Standardized intraoral photographs 
• Clinical examination using Turesky 
Plaque Index 
Phase 3 - After Oral Hygiene (T2) 
• The TRIOS 4 intraoral scanners 
will be used for all scans 
• Scans will capture the entire 
dental arch 
• Standardized photographs of 
vestibular surfaces will be taken 
at each phase 
• The Turesky Plaque Index 
(scale 0-5) will be used as the 
reference method 

• Supervised toothbrushing (Modified Bass 
technique, 2 minutes) 
• Final intraoral scanning 
• Standardized intraoral photographs 
• Toothbrushing will be 
performed with a manual 
toothbrush and fluoridated 
toothpaste 
 
4.7. Image analysis 
The three-dimensional images obtained by the intraoral scanner will be analyzed 
using the Geomagic Control X software. A second examiner, blinded to the 
results of the clinical examination, will perform the following steps: 
 
1. Segmentation of the tooth surfaces of interest  
2. Identification of the areas covered by plaque shown in T1- disclosed 
images 
3. Calculation of the percentage of area covered by plaque in relation to the 
total area of each tooth surface 
This procedure will be performed for the images obtained at T0, T1 and T2 times. 
4.8. Statistical analysis Plan (SAP) 
Data will be tabulated and analyzed using the STATA 15 software. The normality 
of the data distribution will be verified by the Shapiro-Wilk test. 
For comparison between the methods of plate evaluation (reference x digital), 
Spearman's correlation test will be used. 
Differences in plaque amount between T0, T1, and T2 times will be analyzed 
using repeated measures of ANOVA or Friedman's test, depending on the 
distribution of the data. 
The level of significance adopted will be 5% (p<0.05). 
4.9. Risks 
The possible risks associated with this study are minimal, since the 
procedures involved are non-invasive and routine in dental practice. Withholding 
oral hygiene for 24 hours before the procedure may cause mild discomfort and 
temporary bad breath. As for professional scaling and supervised brushing, these 

are safe procedures that can cause temporary sensitivity. The visit will last a total 
of 1.5 to 2 hours, and may vary according to the specific needs of each patient. 
During the procedure, it is possible that the patient will experience some type of 
physical discomfort, such as tenderness or slight pain, especially in cases of 
deeper scaling or in areas with gingival inflammation. All procedures will be 
carried out following strict biosafety protocols and under qualified professional 
supervision. 
4.10. 
Benefits 
 
4.0.1. Direct benefits to participants: 
• Detailed assessment of oral hygiene condition 
•Professional guidance on brushing techniques 
• Free of charge professional cleaning (scaling) 
• Oral health monitoring during the study period 
 
4.0.2. Indirect benefits to the scientific community and clinical practice: 
• Validation of a new digital method for biofilm quantification 
• Development of a more objective tool for clinical evaluation 
• Possibility of better documentation and longitudinal follow-up of patients 
• Potential improvement of oral health prevention practices 
• Contribution to the advancement of digital and preventive dentistry 
4.11.  Criteria for suspending or terminating the search 
The survey will be suspended if 50% of the participants are unable to 
attend the consultations or no longer wish to participate in the study. Other 
eventualities that may interfere with the inclusion criteria and the integrity and 
well-being of the participants may be considered grounds for suspending the 
research (e.g., medical impediment to undergo the research procedures). 
Whatever the reason that suspends or terminates the research for a given 
participant, the latter will not be affected by its treatment. In addition, the research 
participant will not have any loss in referrals for treatment in other dental 
specialties at Univeritas-UNG University. 

 
5. SCHEDULE 
 
Year Month 
Activity 
2025 August- 
December 
- Beginning of recruitment of participants 
- Beginning of clinical data collection and intraoral scans 
2026 January-
April 
- 3D image processing and plaque quantification 
- Statistical analysis of the data 
 
May-June 
- Beginning of the writing of the final report and scientific article 
- Continuation of statistical analysis of the data 
- Interpretation of results 
- Discussion of the results 
 
July 
- Preparation of presentations for congresses 
- Revision and finalization of the manuscript 
- Submission of the article for publication 
 
6. REFERENCES 
 
Abdulkareem, A. A., Al-Taweel, F. B., Al-Sharqi, A. J. B., Gul, S. S., Sha, A., & 
Chapple, I. L. C. (2023). Current concepts in the pathogenesis of 
periodontitis: From symbiosis to dysbiosis. Journal of Oral Microbiology, 
15(1), 2197779. https://doi.org/10.1080/20002297.2023.2197779 
Carter, K., Landini, G., & Damien Walmsley, A. (2004). Automated quantification 
of dental plaque accumulation using digital imaging. Journal of Dentistry, 
32(8), 623–628. https://doi.org/10.1016/j.jdent.2004.06.006 
Del Rey, Y. C., Rikvold, P. D., Johnsen, K. K., & Schlafer, S. (2023). A fast and 
reliable method for semi‐automated planimetric quantification of dental 
plaque in clinical trials. Journal of Clinical Periodontology, 50(3), 331–338. 
https://doi.org/10.1111/jcpe.13745 
Giese-Kraft, K., Jung, K., Schlueter, N., Vach, K., & Ganss, C. (2022). Detecting 
and monitoring dental plaque levels with digital 2D and 3D imaging 

techniques. 
PLOS 
ONE, 
17(2), 
e0263722. 
https://doi.org/10.1371/journal.pone.0263722 
Guo, S., Chen, H., Zhang, Y., Gao, L., Wu, F., & Sun, Y. (2024). Establishment 
and evaluation of a 3D quantitative analysis method for dental plaque 
based on an intraoral scanner technique. International Journal of 
Computerized 
Dentistry, 
27(2), 
141–149. 
https://doi.org/10.3290/j.ijcd.b4000009 
Joseph, B., Prasanth, C. S., Jayanthi, J. L., Presanthila, J., & Subhash, N. (2015). 
Detection and quantification of dental plaque based on laser-induced 
autofluorescence intensity ratio values. Journal of Biomedical Optics, 
20(4), 048001. https://doi.org/10.1117/1.JBO.20.4.048001 
Jung, K., Giese-Kraft, K., Fischer, M., Schulze, K., Schlueter, N., & Ganss, C. 
(2022). Visualization of dental plaque with a 3D-intraoral-scanner—A tool 
for 
whole 
mouth 
planimetry. 
PLOS 
ONE, 
17(10), 
e0276686. 
https://doi.org/10.1371/journal.pone.0276686 
Kinane, D. F., Stathopoulou, P. G., & Papapanou, P. N. (2017). Periodontal 
diseases. 
Nature 
Reviews 
Disease 
Primers, 
3(1), 
1–14. 
https://doi.org/10.1038/nrdp.2017.38 
Könönen, E., Gursoy, M., & Gursoy, U. K. (2019). Periodontitis: A Multifaceted 
Disease of Tooth-Supporting Tissues. Journal of Clinical Medicine, 8(8), 
Article 8. https://doi.org/10.3390/jcm8081135 
Mangano, F., Gandolfi, A., Luongo, G., & Logozzo, S. (2017). Intraoral scanners 
in dentistry: A review of the current literature. BMC Oral Health, 17(1), 149. 
https://doi.org/10.1186/s12903-017-0442-x 

Pretty, I. A., Edgar, W. M., Smith, P. W., & Higham, S. M. (2005). Quantification 
of dental plaque in the research environment. Journal of Dentistry, 33(3), 
193–207. https://doi.org/10.1016/j.jdent.2004.10.017 
Rikvold, P. D., Del Rey, Y. C., Johnsen, K. K., & Schlafer, S. (2023). Semi-
Automated Planimetric Quantification of Dental Plaque Using an Intraoral 
Fluorescence Camera. Journal of Visualized Experiments, 191, 65035. 
https://doi.org/10.3791/65035 
Turesky, S., Gilmore, N. D., & Glickman, I. (1970). Reduced Plaque Formation 
by the Chloromethyl Analogue of Victamine C. Journal of Periodontology, 
41(41), 41–43. https://doi.org/10.1902/jop.1970.41.41.41 
You, W., Hao, A., Li, S., Wang, Y., & Xia, B. (2020). Deep learning-based dental 
plaque detection on primary teeth: A comparison with clinical 
assessments. 
BMC 
Oral 
Health, 
20(1), 
141. 
https://doi.org/10.1186/s12903-020-01114-6 
Zimmermann, M., Mehl, A., Mörmann, W. H., & Reich, S. (2015). Intraoral 
scanning systems—A current overview. International Journal of 
Computerized Dentistry, 18(2), 101–129. 
 
 
 

7. Appendix 1: Ethical committee Approval 
 
 
 

 
 

 

 

 
 
 
 

8. Appendix 2: Informed Consent  
 
 
INFORMED CONSENT FORM 
 
STUDY TITLE: Digital quantification of dental plaque based on intraoral 
scanner images 
PRINCIPAL INVESTIGATOR: Prof. Dr. Mohamed Ahmed Hassan (UNG) 
INSTITUTION: Center for clinical Studies and Research. Guarulhos University 
(UNG).  
PHONE: (11) 972945957 
OTHER RESEARCHERS: Prof. Dr. Jamil Awad Shibli (UNG), Profa. Dr. 
Luciene Cristina de Figueiredo (UNG), Lucas Daylor Aguiar da Silva (UNG) 
 
Participant Initials: 
 
Participant's date of birth: 
 
 
 dd/mm/yyyy 
Participant Number: 
 
 
 
RESEARCH ETHICS COMMITTEE CEP: 
The Research Ethics Committee (CEP) is an interdisciplinary and independent collegiate 
body, of an advisory, deliberative and educational nature, created to defend the interests 
of the research subjects in their integrity and dignity and to contribute to the development 
of research within ethical standards. Ethics Committee for Research with Human Beings 
– UNG (5506); Guarulhos University – UNG. Address: Praça Tereza Cristina, 88 – 
Centro – Guarulhos/SP – CEP: 07023-070, 5º andar / Edifício E, e-mail: 
comite.etica@ung.br, Tel: (11) 2464-1664. Opening hours to the public: Monday - Friday: 
10:00 am to 4:00 pm 
 
INVITATION TO PARTICIPATE IN THE STUDY 
With this informed consent form (ICF), we invite you to participate in this research 
project, which is a clinical study on digital quantification of dental plaque. This invitation 
confirms that your participation in the study is voluntary and that you can withdraw this 
consent and leave the project at any time during the research, without prejudice to the 
continuity of treatment. 
The study will be conducted at the Center for Clinical Studies of the University of 
Guarulhos (UnG), where participants of both genders aged between 18 and 65 years 
who seek treatment at the clinics of the University of Guarulhos will be selected to obtain 
a sample number of (n= 20). This sample size calculation was based on previous studies 
and participants must comply with the inclusion and exclusion criteria described below. 
 

STUDY OBJECTIVES 
I certify that I have been verbally clarified that dental plaque is the main etiological 
factor of periodontal diseases and its accurate quantification is essential for diagnosis 
and clinical monitoring. The proposed treatment aims to develop a new digital method 
for quantification of dental plaque using three-dimensional images obtained by intraoral 
scanner. 
As described in the project, the primary and secondary objectives are, respectively: 
-The primary objective of the study will be to develop and validate a digital method for 
dental plaque quantification based on three-dimensional images obtained by intraoral 
scanner. 
-The secondary objectives will be to compare the accuracy of the proposed digital 
method with the traditional method of clinical evaluation of dental plaque, to investigate 
the ability of the method to detect changes in the amount of plaque after tooth brushing, 
and to analyze the patterns of plaque distribution on tooth surfaces using three-
dimensional images. 
 
The study hypotheses: 
The ability of the digital method to analyze plaque distribution patterns on tooth 
surfaces is not inferior to the traditional method, considering a non-inferiority margin of 
10%. 
 
PARTICIPATION IN THE STUDY 
During the invitation to participate, it became clear that the study will be conducted at the 
Center for Clinical Studies of the University of Guarulhos (UnG), in which participants who 
have visible dental plaque will be selected. I was informed that to participate in this study, I 
must attend on the pre-established days and times, and not perform oral hygiene for 24 hours 
before the first appointment. 
During my participation, a series of clinical procedures will be performed that include: digital 
scanning of the teeth using an intraoral scanner, application of a dental plaque highlighting 
solution, standardized photographs of the teeth, clinical visual examination and supervised 
brushing followed by a new scan. All these procedures will be performed by trained and 
qualified professionals. 
As a study participant, I will have access to the results of all evaluations and 
examinations performed, as well as the results of the overall survey. The researchers 
undertake to keep me informed of the progress of the study and to clarify any doubts 
that may arise during my participation. 
 
PROCEDURES  
I was informed that during my participation in the study, the following clinical procedures will 
be performed in a single session: initially, a digital scan of my teeth will be done using an 
intraoral scanner, lasting 10 to 20 minutes. Then, a plaque highlighting solution will be applied, 
followed by a rinse with water for 10 seconds. 
After disclosure, standardized photographs will be obtained and an examiner will perform a 
detailed clinical evaluation in about 10-20 minutes, followed by a new scan with the evidenced 

plaque. Finally, I will perform a supervised brushing for 2 minutes and a final scan of my teeth 
will be done. The visit will have a total duration of 1.5 to 2 hours. 
All procedures will be carried out by professors and graduate students in the area of 
periodontics and implantology at the University of Guarulhos, following strict biosafety 
protocols, and I will have access to the results of all evaluations carried out. 
BENEFITS 
I was clarified that the main benefit of participating in this study is to contribute to the 
development of a new technology that will allow a more accurate assessment of dental 
plaque. As a participant, I will receive personalized guidance on proper oral hygiene 
techniques and have a detailed follow-up of my oral health throughout the study period. 
Finally, the research participants who need it will receive a referral for treatment in the 
other dental specialties of the centers participating in the study. 
 
RISKS AND DISCOMFORTS 
I am aware that participation in this study involves LOW RISKS related to clinical evaluation 
procedures. Possible discomforts include the time required to not perform oral hygiene before 
the first consultation (24 hours), possible sensitivity during the application of the plate discloser, 
and possible discomfort during the scanning process due to the time required to capture the 
images. To minimize these risks, all procedures will be performed by trained professionals, 
following established clinical protocols. 
 
TIME OF PROCEDURES 
I was informed that the planned treatment will be carried out in a single session lasting 
approximately 2 hours. To evaluate the results, I will have to attend the research center 
two more times after the initial procedure for the control and data collection sessions, 
lasting approximately 30 minutes each. 
 
EXPENSES AND PAYMENTS 
I am aware that I will not have costs related to the treatment proposed here: 1) digital scanning; 
2) clinical evaluation; 3) plaque discloser; 4) oral hygiene guidance; and 5) transportation cost 
for the visits determined in the project. I further declare that I am aware that I will not receive 
any remuneration or advantage for participating in the survey. 
 
GUARANTEE OF CONFIDENTIALITY  
I was informed that I have the guarantee of confidentiality that ensures my privacy in the 
study. Once the data are obtained, they can be published in scientific journals and 
conferences, but without my identity as a research participant. 
 
RIGHT TO WITHDRAW  
I am aware that my acceptance to participate in the survey may be undone. I will be 
guaranteed to receive further clarifications that I deem necessary before and during the 
research, and I will have full freedom to refuse to participate in the research at any time, 
without any prejudice or compromise of the treatment. 
COMPENSATION  

As a participant in this survey, you are entitled to reimbursement for expenses related 
to your attendance at the visits, including public transportation and a snack. 
 
DATA REUSE 
Do you authorize the use of your treatment information in other research? 
( ) I do NOT authorize the use of data in another survey.  
( ) YES I authorize the use of data in another research, provided that the new 
research is approved by the Research Ethics Committee 
 
INDEMNIFICATION FOR ANY DAMAGES RESULTING FROM THE RESEARCH 
It was informed that participation in the study will not cause expenses, and 
therefore there is no provision for reimbursement. Regarding the forms of 
compensation and the measures to repair in case of any damage, I am aware that 
participation in this study involves minimal risks, mainly related to possible 
discomfort during the evaluation procedures. In case of complications or adverse 
reactions, I will receive: Immediate care at the graduate clinic, follow-up by the 
researcher in charge, referral to specialties when necessary. 
 
DATA CONFIDENTIALITY 
I am aware that for the tabulation of the data each participant of the study will receive a 
code, and the information collected will be coded in such a way that only the researchers 
involved in the data collection will have the knowledge of the identification of the study 
participants. 
 
CRITERIA FOR SUSPENDING OR TERMINATING THE SURVEY 
The survey will be suspended if 50% of the participants are unable to attend the 
consultations or no longer wish to participate in the study. Other eventualities that may 
interfere with the inclusion criteria and the integrity and well-being of the participants may 
be considered grounds for suspending the research (e.g., medical impediment to 
undergo the research procedures). Whatever the reason that suspends or terminates the 
research for a given participant, the latter will not be affected by its treatment. In addition, 
the research participant will not have any loss in referrals for treatment in other dental 
specialties at Univeritas-UNG University.  
 
CONTACT INFORMATION 
I was informed that the result of the treatment will be directed by the principal investigator 
Mohamed Ahmed Hassan Telephone: (11-972945957) from Univeritas-UnG, to which 
I will have access to clarify any doubts throughout the study. I am aware that all the 
ethical norms of the present study are in accordance with the guidelines and norms of 
the National Health Council in Resolution No. 466/12. 
But, if I have any considerations or questions, I can also contact the Research Ethics 
Committee (REC). 
 
 

PARTICIPANT CONSENT 
I confirm that I discussed until I was satisfied about my decision to participate in this 
study: Digital quantification of dental plaque based on intraoral scanner images. It 
was clear to me what the purposes of the study are, the procedures to be carried out, its 
discomforts and risks, the guarantees of confidentiality, how the data will be used and 
disseminated, and permanent clarifications. It was also clear that my participation is free 
of charge and that I am guaranteed access to treatment or guidance when needed. I 
voluntarily agree to participate in this study and may withdraw my consent at any time, 
before or during it, without penalty or impairment or loss of any benefit I may have 
acquired, or in my attendance at this service. 
 
This document was prepared in two copies, one for the research participant and the other 
for the responsible researcher. 
 
             /            / 
Date 
 
Participant Name: __________________________________________________________ 
 
 
Participant's signature: ___________________________________RG:________________ 
 
  
 
Name of the person who explained the consent: ______________________________________ 
 
 
Signature of the person who explained the consent: __________________________________ 
                       
 
 
                            
Mohamed Ahmed Hassan 
Principal Investigator  
CROSP: 152,221 
RG: 69.435.424-7 
 
 
 
Professional Address:  
University of Guarulhos 
Center for Graduate Studies and Research. Rua Engenheiro Prestes Maia, 88, Centro- 
Centro - Guarulhos - Estado de São PauloCEP: 07011-080Phone: (11) 972945957 
Email: mohamed.hassan@prof.ung.br URL da Homepage: http://www.ung.br