DIMOH: New Digital Methods for Monitoring Oral Health. An in Vivo Assessment
Conditions: Dental Caries, Tooth Wear
Sponsor: University of Copenhagen

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K Ø B E N H A V N S   U N I V E R S I T E T   -  T A N D L Æ G E S K O L E N  
 
  
 
Forsøgsprotokol  
Jf. GCP-enhedens protokolvejledning  
(The main research protocol is developed based on the guidelines for Good Clinical Practice 
(GCP)) 
  
  
  
1. Title:  
DIMOH: New Digital Methods for Monitoring Oral Health. An in vivo assessment. 
Odontologisk Institut - Tandlægeskolen 
Det Sundhedsvidenskabelige Fakultet  
Københavns Universitet 
Nørre Allé 20, 2200 København N 
 
 
 

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2. Objectives 
The objectives of this study are i) to monitor the oral health of young people over a period of 
12 months and ii) to assess the ability of a new intraoral scanner combining fluorescence (from 
emitted blue light) with 3D imaging to detect and monitor changes in the dental hard tissues in 
vivo. 
a. Hypotheses 
The working hypotheses of this study are: 
1. The monitoring of oral health will benefit from using a new intraoral scanner 
combining fluorescence with 3D imaging. 
2. The new intraoral scanner combining fluorescence with 3D imaging will aid dentists 
to identify changes in the dental hard tissues at earlier stages than the traditional 
diagnostic methods (i.e. visual-radiographic methods).  
b. Background 
Literature Review and Research Question 
Currently, monitoring oral health relies mainly on the visual examination of the oral tissues by 
the dental professional, aided electively by radiographic or photographic images (1, 2). In the 
context of oral health, monitoring involves detecting changes, sometimes rather subtle, in the 
soft or hard oral tissues; such changes are associated with the development of oral diseases or 
ageing (3, 2). Through the course of their lives, people will experience changes in the level of 
gingiva, increments on the teeth surface due to calcification of biofilm, loss of mineral tissues 
due to caries or tooth wear, wear of restorative materials, or modification in the in the position 
or color of the teeth. The slow rate of change involved in some of these situations makes it 
extremely difficult for the human eye alone to identify them. It is even more challenging to 
accurately register and recall the original situation on the patient’s follow-up visits. Clinical 
photographs are therefore used to aid the monitoring (4, 2); however, it is difficult to obtain 
comparable photographs from different points in time and the subjectivity involved in the 
process cannot be avoided. 
Different criteria are used in clinical practice to register and monitor changes in the oral tissues, 
according to the specific condition under investigation. While identifying significant changes 
is an easy task, the challenge lies particularly in identifying early, incremental changes. 
Regarding the detection of caries lesions, a number of initial lesions typically remain unnoticed 
when visual examination alone is used (5); or even when radiographs are employed, as the 
latter are not sensitive to early demineralization in enamel (6). Concerning tooth wear (i.e. 
erosion, abrasion, attrition), as the gradual mineral loss occurs progressively and irreversibly, 
it is usually only noticed when a significant amount of hard dental tissue is already lost (2). 
Additionally, minor changes on the gingival level, e.g. resulting from improper oral hygiene 
habits or yet an early inflammation of the periodontal tissues, may pass unnoticed to the dental 
personnel.   
A promising clinical solution to overcome the challenges involved in the detection of early 
changes and monitoring of oral tissues is the use of 3D intraoral scans (7, 8). 3D scans obtained 
from gypsum models (ex vivo) have previously been used to identify changes of tooth position 
(9, 10), gingiva volume (11, 12), loss of mineral tissues (13) or wear of restorative materials 
(14). Although gypsum models offer information about volumetric changes (e.g. tooth 

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substance loss, movement of teeth, gingival level, stagnation of biofilm), the color information 
is lost. However, color is a valuable parameter for the previously mentioned clinical criteria as 
it is one of the parameters used to identify diseases (e.g. caries, gingivitis) or other oral 
conditions (e.g. tooth discoloration due to ageing, tooth whitening or discoloration of dental 
materials) (15, 2). Hence, obtaining 3D scans directly from the patients (in vivo) using intraoral 
scanners is desired, as these scans contain color information of the natural tissues. Additionally, 
by comparing 3D scans obtained from the same patients at different points in time, a less 
subjective and more reliable comparison of data is expected: the 3D scans can be overlapped 
and analyzed using specific software (9, 7, 16). Therefore, it is hypothesized that 3D intraoral 
scans can be used for more consistent monitoring of oral health in relation to clinical 
photographs or clinical records.  
The current 3D intraoral scanners capture the color of the oral tissues by emitting visible white 
light. A recently developed 3D intraoral scanner manufactured and CE marked by 3Shape A/S, 
Denmark, is also able to emit visible blue light (405 nm wavelength) (17) that allows capturing 
fluorescence from the oral tissues. Fluorescence is one of the most promising technologies for 
accurate detection of the early stages of enamel demineralization (18, 19, 20), but is currently 
available only in 1D or 2D devices. The main limitation of the existing devices featuring 
fluorescence, as already mentioned, is the challenge in comparing single images obtained at 
different points in time, which is at large influenced by imaging artifacts and noise. Imprecision 
in the comparison of these images compromises the ability to accurately monitor progressive 
demineralization of the dental hard tissues. To the best of our knowledge, there is no intraoral 
scanner reported in the scientific literature that combines fluorescence with 3D imaging. Thus, 
we hypothesize that this new intraoral scanner will benefit the monitoring of dental hard tissues 
and will aid dentists to identify early changes in tissue mineralization. With this method it is 
only possible to examine the tooth surfaces that are visible and directly exposed into the mouth 
(i.e. the smooth free surfaces and the occlusal fissures); the areas between the teeth (i.e. the 
approximal surfaces) cannot be visualized and therefore cannot be examined using the scanner.  
3. Methods 
Study execution 
The participants will be monitored for a period of 1 year. The study will last approximately 2 
years in total, with the baseline examination taking place in the beginning of 2019 and the 
last examination in the Spring – Winter 2020. Detailed plan of the study is shown in Table 1.  
Information about the project 
Potential participants will find contact information of the responsible researcher on diverse 
project announcements. By contacting the responsible researcher, the potential participants 
accompanied by their parents/guardians (in case of underage candidates) will be able to book 
time for an information meeting regarding the clinical oral examination and will receive 
detailed written information material about the study. Appropriate language will be used to 
make sure that the information is clearly understood by all potential participants. The potential 
participants and their parents/guardians will be asked to read the written information before 
the in-person information meeting.  
The in-person information meeting will take place in a room where no disturbances can occur. 
All underage candidates should be accompanied by their parents/guardians. The responsible 

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researcher will inform the potential participants about the study and the clinical procedures. 
The responsible researcher is a dentist with experience in communicating with young patients 
and has finalized pedagogical training. Therefore, she fulfills the prerequisites to be the 
responsible person to inform the young participants.    
After attending the information meeting and they (for adults) or the parents/guardians (for 
underage) receiving a copy of the inform/parental consent, 24 - 48 hours will be allowed to 
decide about participation. Furthermore, they will all be informed about the voluntary nature 
of participation in the study and the freedom to withdraw – at any time – their participation. 
All potential participants will receive the documents “Før du beslutter dig” which includes the 
“Forsøgspersoners rettigheder i et sundhedsvidenskabeligt forskningsprojekt” , which they are 
encouraged to read thoroughly. Copies in Danish and English will be provided for the Danish 
and Greek participants respectively.  
Participants who decide to join the study will be asked to fill out a 4-day diet history, from 
Friday through Monday (Appendix 1). There the participants should register everything that 
they eat and drink, excluding water. Furthermore, they will be asked to fill out a questionnaire 
regarding their oral hygiene habits (Appendix 2). Both forms will be provided at the in-person 
information meeting, together with the copy of the inform/parental consent. All forms should 
be delivered on the second appointment (baseline examination).  
Clinical and radiographic examination  
A second appointment will be scheduled to conduct the oral health examination, including 
intraoral scanning and 2 bitewing radiographs (BW). The responsible researcher will request 
the participants to provide any recently available BW, in case these are not older than 6 months. 
No study-related examination will be conducted before the signed parental consent form has 
been obtained by the responsible researcher. The participants will not be offered any treatment 
other than routine professional tooth cleaning, which is important for a thorough visual 
examination and scanning of the teeth. In case any oral disease is detected, the participants will 
be referred to their dentist for treatment.  
If no radiographs are available from the past six months, BW of the upper and lower posterior 
teeth on both sides will be taken. Since radiographs are part of the participants’ annual dental 
check-up, these will be made available to the participants’ dentist. Additionally, an oral 
examination will be conducted, and the condition of teeth, gums and fillings will be registered. 
The approximal plaque accumulation will be registered by employing the approximal plaque 
index (21). Thereafter, the teeth will be professionally cleaned, and the presence of caries 
lesions will be registered based on the visual and radiographic assessments. Caries lesions will 
be characterized as active or inactive and classified according to the ICDAS criteria into 7 
stages (22). Furthermore, the presence of other visible defects on the oral hard tissues (i.e. 
erosive – abrasive lesions) will be registered using appropriate criteria (i.e. BEWE index for 
erosive tooth wear) (2, 23).  
Subsequently, both the upper and lower jaw of the participant will be scanned using the 
intraoral scanner (Trios 4, 3Shape Trios A/S, Denmark). Scans will be obtained using visible 
white and blue light (wavelength 415 nm).  
At the end of the session, the participants will be classified into different risk groups (low, 
moderate, high) according to the clinical findings and the information collected from the diet 

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history and the oral hygiene habits questionnaire (Appendix 1, 2). According to this 
classification, the responsible researcher will set the follow-up intervals for each participant 
(3-12 months). All patients will be monitored for 1 year. 
The same clinical procedures will be followed on the follow-up examinations (3 or 6 months) 
as well as on the final examination (1-year follow-up). The diet history, the oral hygiene habits 
questionnaire and the BW radiographs will be repeated only on the final examination (Table. 
1).  
4. Statistics 
Paired T-test will be conducted to identify differences between the clinical scores at the 
baseline and the subsequent follow-ups for the different conditions investigated (i.e. caries 
score, erosion score) (24). 
Exploratory analysis of the data extracted from the 3D scans will be conducted and compared 
to the clinical scores. Pearson correlation coefficients between the clinical scores and scores 
obtained from the 3D scans will be calculated. Paired t-test will be conducted to compare the 
number of lesions per patient (i.e. caries, tooth wear) that will be detected with the 2 different 
methods (scanning and clinical-radiographic examination).  
All statistical analysis will be conducted using a 95% level of confidence. 
Information regarding the sample size calculation using power analysis is provided on the 
following paragraph (§5. Research subjects - Sample size calculation) 
5. Research subjects 
The participants in this research project will be adolescents (12-16 years old) and young adults 
(18-19 years old) in Denmark and in Greece respectively.  
As previously mentioned, this project will assess the ability of the intraoral scanner combining 
fluorescence to detect and monitor initial changes in the dental hard tissues, with special focus 
on caries: the most prevalent oral disease. The most important benefit expected by using the 
fluorescence method is the detection of initial lesions on dental surfaces directly exposed to 
the mouth. Fissure lesions in permanent posterior teeth usually appear in the long-lasting period 
of tooth eruption, i.e. from when the tooth first appears in the mouth until it contacts with the 
opposite dentition (28). Eruption of the first permanent molar starts around the ages of 6-8 
years, the second molar at 12-14 years (28) and the third molar at 17-18 years. During the 
eruption period, the posterior teeth are at a higher risk for developing fissure caries. For the 
second permanent molars, this period can last up to 27 months form the first appearance in the 
mouth (~12 years old) (29) though for the third molars this period is usually longer. 
The initial state of the caries lesion is short-lived before progression of the disease. In older 
patients, caries lesions in fissures are either found at more advanced stages or they have already 
been treated by the dentist (i.e. sealed, filled or extracted as in the case of third molars) (28). 
Although initial caries lesions can be found in older patients, such initial lesions are located on 
the surfaces between the teeth, which are not visible to the intraoral scanner and therefore 
cannot be detected using this method. 
For these reasons, the age group is set from 12 to 19 years. It is necessary to conduct the study 
on this group of young people, as the study is expected to benefit them directly. The same 
benefits are not expected if the study is conducted in older adults.  

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The early diagnosis of initial lesions in the young participants is more beneficial as it will allow 
the implementation of preventive measures to stop the progression of the disease. This will 
decrease the complexity of the treatments needed in the target group, as the initial lesions can 
be treated with minimal or non-invasive approaches. Thus, the economic burden for the state 
regarding treatment expenses of the adolescents and the individual costs related to future dental 
treatment will be reduced. 
Inclusion criteria:  
- 
Young people (12-19 years old) without chronic diseases. 
Exclusion criteria:  
- 
Participants in need of complex dental treatment (e.g. extensive restorative work, 
extractions, prosthetic treatment). 
- 
Participants using partial/complete removable dentures or other appliances (i.e. 
orthodontic devices).  
Sample size calculation 
Caries data was used in order to calculate the desirable sample size for the current study, as 
that is the most prevalent oral disease in young patients and is widely investigated in 
epidemiological studies (1). Therefore, data regarding initial caries lesions was used for the 
sample size calculation, assuming that the new method will aid dentists to detect significantly 
more initial caries lesions compared to traditional methods. 
For the sample size calculation, data collected by the Central Odontology Register of the 
Danish National Board of Health (Sundhedsstyrelsens Centrale Odontologiske Register - 
SCOR) during the year 2017 from municipal dental clinics at 98 different municipalities in 
Denmark was used. According to the data, an average of 3.08 initial lesions, with a standard 
deviation of 1.23 were identified on 15-year old patients at the different municipalities. In this 
study, the desirable power was set on 90%, the level of significance on 5% and the effect size 
on 30% (1 lesion). By applying these parameters, the sample size was calculated to be 64 
adolescents. Nevertheless, as a 10% drop-out is expected for this type of study, the final 
number of participants to be included in the study should be 70.   
 
6. Risks, side effects and shortcomings in short and long term 
Risks 
This study will be conducted on healthy persons, on whom the procedures followed in this 
study are assumed to have a negligible risk.  
No risk is related to the clinical visual examination. 
Regarding the 3D intraoral scanning procedure, if the scan quality is poor and thus the scan is 
not useful for the research objectives, the scanning procedure should be repeated. This is of no 
risk for the patient but represents the inconvenience of a delay of the dental visit.  
For the scanning using blue light (wavelength 415nm) possible risks exist. For the participant, 
light irritation of the mucosa and lips may result from a local, acute overexposure to the strong 
blue light. This irritation, though, is mild and temporary. For the operator, possible harm to the 
eyes, especially on the lenses and the retinal tissues, may be caused by long-term cumulative 
exposure to blue light. These risks are not particular for this specific intraoral device but are 

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common to any dental equipment that uses blue light. Having these risks in mind, the 
equipment will be used properly and with care: the exposure time will be limited to 15 seconds 
per tooth and direct exposure to mucous membranes will be avoided. The equipment will be 
started only after it has been inserted into the patient’s mouth. The operator will avoid looking 
directly into the mouth and instead will look on the computer screen during the scanning 
procedure. Eye-protection goggles filtering light under 500 nm are suggested to be used by the 
operator.  
According to the Classification for Medical Devices in Europe, the mentioned 3D scanner is a 
Class 1 device and therefore is considered of low risk. All in all, minimal risks are at stake for 
the participants and the operator under proper use of the equipment. Any safety issues will be 
reported to the manufacturers, the VEK and the Patient Safety Board. 
Side-effects 
There is no side effect from the clinical examination or the scanning.  
The radiation dose used for the acquisition of the dental radiographs varies between 1-10 µSv, 
depending on the technique used, and is equivalent to the average background radiation dose 
for 2-20 hours (the natural background radiation in Denmark is 3 mSv per year) (25). This 
project is classified as Category 1 according to the guidelines from the International 
Commission of Radiation Protection (ICRP) and the European Commission (26, 27). The 
overall stochastic effect from the exposure of the participants to ionizing radiation is estimated 
to be 1 in 1 million or smaller and the risk is thus considered insignificant. 
Shortcomings: 
All the procedures followed in the study (scheduling, radiographs, dental check-up, scanning) 
are time consuming and may inconvenience the participants.  
7. Biological material 
No biological material will be obtained from the participants or from another existing biobank. 
 
8. Information from the participants’ medical journal 
No information will be retrieved from the participants’ medical journal. The required 
information for the present study will be extracted from the participants during the clinical 
examination and scanning. All information will be registered on the digital dental journal used 
internally at the Dental Schools of the University of Copenhagen and the National and 
Kapodistrian University of Athens (for the Danish and Greek participants respectively. 
External, unauthorized people do not have access to this database.   
Recent BW radiographs (no older than 6 months) will be retrieved from the participants’ dental 
journal only after the participants’ consent.   
9. Data handling 
The data will include the condition of oral health (plaque, caries, tooth wear etc.) gathered from 
the visual and radiographic assessments, as well as from the 3D scans. All data and sensitive 
personal information obtained from the participants will be treated and stored in compliance 
with the EU General Data Protection Regulation (GDPR) and following good research ethics.  

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10. Participant Recruitment  
The study will be advertised at local schools and at the Dental Schools of the University of 
Copenhagen and the National and Kapodistrian University of Athens (on announcement boards 
and/or on the schools’ webpages) and eventually giving presentations about the study by the 
responsible researcher. Further information regarding the informed consent and the in-person 
information meetings with the participants are provided on paragraph §3. Methods – 
Information about the project.  
11. Research Ethics 
The physical and mental integrity of the participants, as well as their privacy, will be respected. 
The good clinical practice (GCP) guidelines and EU General Data Protection Regulation 
(GDPR) will be followed. 
Benefits of the Study  
The risks, shortcomings and side effects (see above) are surpassed by the benefit of early 
diagnosis of oral diseases. The early diagnosis benefits the participants because oral problems 
can be treated more easily before they develop into more severe problems. The early detection 
of oral diseases is crucial, as often the problems can be treated non-invasively and different 
preventive strategies can be implemented to stop disease progression.  
Additionally, the 3D intraoral scanner has the potential to aid dentists identifying changes in 
the oral tissues at earlier stages than with the visual – radiographic examinations. If this 
concretizes, the use of this equipment may potentially reduce the need for ionizing radiation 
for detecting oral problems and monitoring oral health, something that would be of significant 
benefit to all patients. 
12. Participant compensation 
This study is carried out on healthy persons under the direct responsibility of the dental 
school – University of Copenhagen. Thus, possible injuries to participants will be covered by 
the Danish “Patienterstatningen”.  
 

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Table 1. Study Plan 
 
 
 
 
 
 
 
 
 
 
Information meeting 
 
 
(~20 min) 
Baseline examination 
January – September 
2019 
 
(~60 min) 
3-month / 6-month 
follow-up examination 
(only for moderate/high 
risk groups) 
July 2019-March 2020 
(~45 min) 
1-year follow-up 
Final examination 
April – September 2020 
(~60 min) 
Study Termination 
September – December 
2020 
• Oral information 
about the clinical 
examination 
• Distribution: 
- Inform consent 
agreement 
- Diet history 
registration form 
- Questionnaire about 
oral hygiene habits 
• Registration of diet 
history and oral 
hygiene habits 
• Clinical examination 
(registration of 
plaque, caries and 
other findings) 
• Teeth cleaning 
• Radiographic 
examination 
• Scanning  
• Participant risk 
assessment – Set 
follow-up intervals 
• Data selection and 
management 
• Clinical examination 
(registration of 
plaque, caries and 
other findings) 
• Teeth cleaning 
• Scanning 
• Data selection and 
management  
 
• Registration of diet 
history and oral 
hygiene habits 
• Clinical examination 
(registration of plaque, 
caries and other 
findings)  
• Teeth cleaning 
• Radiographic 
examination 
• Scanning 
• Data selection and 
management 
 
• Data management 
• Statistical analysis 
• Publication 
 

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