Preliminary Phase IV Trial Comparing the SOVA Night Guard With the Clinical Standard Acrylic Orthotic
Phase: NA
Conditions: Sleep Bruxism, Tooth Wear
Sponsor: University of Michigan

 
 
Nocturnal Mouth Guards, SOVA vs. Standard Acrylic 
Orthotic; Phase IV (SISU-SOVA) 
 
NCT 02340663 
 
04/10/2015 
 
 

 
 
 
Page 1 
 
 
 
 
 
1. OVERVIEW AND OBJECTIVES 
The long-term objectives of this research are to perform large-scale randomized clinical trials (RCT) 
with SISU mouth guards and SOVA night guards. Towards these long-term ends, the present proposal 
represents investigations into the most immediate issues that can be addressed in a preliminary study. 
The outcome variables for the present study fall into four categories: (1) fabrication efficacy, (2) 
compliance, (3) functional efficacy, and (4) user satisfaction. The immediate goals of this preliminary 
proposal will: (1) focus on the SOVA night guard, (2) conduct in vivo tests of the SOVA device under 
controlled clinical conditions, and (3) evaluate compliance and functional efficacy in the ‘natural’ 
environment of the patient’s home. The clinical application involves protection of dental structures during 
nocturnal parafunction (sleep bruxism). Because of the potential co-morbidity of bruxism with 
temporomandibular disorders (TMD), a triad of masticatory myalgia, TM joint noises and/or joint 
arthritides, TMD signs and symptoms will be considered in future studies. Future goals will involve 
pursuing funding to perform large-scale RCT with both the SISU and SOVA night guards. 
Specific Aim 1. Compare the SOVA night guard to the custom-acrylic bite splint in clinical 
laboratory conditions. Hypothesis: There will be no significant differences between the devices in terms 
of fabrication efficacy, functional efficacy or user satisfaction. 
 
Specific Aim 2. Compare the SOVA night guard to the custom-acrylic bite splint under 
ecologically relevant conditions, i.e., the home environment. Hypothesis: There will be no significant 
differences between the devices in terms of compliance or functional efficacy. 
 
2. BACKGROUND AND SIGNIFICANCE 
 
Bite splints and bruxism. Tooth wear is an extremely prevalent condition, with > 4 teeth per dentition 
showing significant wear in over 50% of the population, and the prevalence increases with age to 60% by 
the 7th decade of life (Cunha-Cruz et al., 2010). Moreover, patients who have a history of previous bite 
splint wear have higher rates of tooth wear (Cunha-Cruz et al., 2010), suggesting that early intervention 
and long-term splint wear are required to reduce the impacts of bruxism. 
Bite splints and TMD. Recent evidence suggests that bite splint use is efficacious in reducing pain 
symptoms in TMD patients who have been wearing splints for 1 – 6 months; however, within 15 days of 
terminating splint use, symptoms return (Rehm et al., 2012). These authors conclude that terminating bite 
splint use in TMD patients is not recommended. If this is correct, then bite splints for TMD symptom 
management require long-term, perhaps permanent, use. Given that no oral devices are permanent and 
that custom acrylic orthotics are expensive to replace, there exists a need for an alternative that is 
feasible in terms of cost, reliability, and regular replacement. 
Current standards. There are three recognized oral devices (Maeda et al., 2009), (1) a stock type, which 
does not adjust to an individual’s dentoskeletal morphology, (2) the mouth-formed or boil and bite type 
and (3) the custom-made appliance. The first two types are over-the-counter (OTC) devices. Bite splints 
for use with TMD and bruxism are most often custom-made. Either custom-made or the boil and bite type 
are most often used as mouth guards in contact sports. 
Evidence varies as to which of the three oral devices is superior. Most experts presently recommend the 
custom-made mouth guards for sports purposes (Maeda et al., 2009). For sleep bruxism, custom-made 
hard acrylic or boil and bite night guards are apparently equally efficacious (Klasser et al., 2010). Finally, 
a review of RCTs indicates that hard acrylic orthotics were superior to soft appliances or repositioning 
appliances in managing TMD pain (Fricton et al., 2010). 
The issue with custom-made hard acrylic appliances is that they are expensive and cannot be repetitively 
covered by insurance. Hence, there is a need for an inexpensive, reliable and replaceable alternative that 
has the functional efficacy of the custom hard acrylic appliances. It is also clear that, for such a device to 
be a legitimate alternative, it must undergo the appropriate clinical trials (ADA report. Using mouthguards 
to reduce the incidence and severity of sports-related oral injuries., 2006; Centers for Disease Control 
and Prevention. Promoting oral health: interventions for preventing dental caries, oral and pharyngeal 

 
 
 
Page 2 
 
 
N=
N=80 
N
N=70; 1 mo
N= 
N= 
N=64; 3 & 6 
N=6 
N=58 
Fig. 1. Estimated recruitm 
= 
n 
2 
4 
m
 
 
cancers, and sports-related craniofacial injuries. A report on recommendations of the task force on 
community preventive services., 2001; Fricton et al., 2010). 
 
Planned studies will escalate as follows.  The initial studies will involve preforming a small RCT with 29 
subjects in two groups (below).   Subsequent future research will involve full-sized phase III trials of the 
SOVA night guard, while simultaneously developing a jaw function simulator.  The technologies and 
insights developed from the simulator and phase III trials will provide solid methods for successful phase IV 
SOVA trials.  Subsequently, the advances made with the SOVA studies will provide the necessary means 
for conducting phase III and IV trials of the SISU mouth guard device, which will take place under the 
hostile conditions attending contact sports.  Of course, additional IRB approvals and funding will be 
required to pursue these future objectives. 
3. METHODS AND STUDY DESIGNS 
3.1 Subjects. Sample size estimations (Table 1) are based upon a recent review of RCTs for bruxism 
management, in which acrylic appliances were evaluated (see Appendix 2 in (Huynh et al., 2007)). The 
mean + 1 SD number of bruxism episodes per hour with an occlusal splint (the gold standard) was 3.97 + 
0.58, and for a palatal splint, the mean + 1 SD was 4.45 + 0.63. Using these means and the higher SD 
(0.63), along with an = 0.05 and = 0.8, I determined that a study would be sufficiently powered with 
sample sizes of 29 per group. Based on other Michigan studies, I have estimated recruitment, exclusion 
and attrition rates, which suggest an estimated initial screening sample size of 120 necessary to end up 
with 29 per group (Fig. 1). There will be two treatment groups: a group receiving supervised training in 
the fabrication of the SOVA night guard (SOVA) and a group receiving the Michigan custom-acrylic bite 
splint (MI BS). Two groups times 29 subjects per group equals 58 total needed for analysis (Fig. 1, 
bottom). 
Table 1. Treatment (Tx) groups & sample sizes (N). 
N=120 
N=40 
Care will be taken to match the randomized groups for 
age,   ethnicity,   gender   and   TMD   signs/symptoms. 
Alternatively these will be modeled as nuisance 
variables if attrition rates create bias and/or there is a 
lack of sufficiently sized screening pools. Subject 
inclusion criteria will be: (1) adults, male or female, (2) 
clinical signs of dental wear, (3) report from significant 
 
 
 
N=80 
 
 
 
 
 
N=10 
others of nocturnal grinding and clenching noises from 
potential subject, (4) absence of outstanding dental and 
medical conditions, including cardiovascular disease, 
sleep apnea, and diagnosed sleep disorders, (5) full 
dentition sans 3rd molars, (6) no movement or 
neurological disorders, (7) no active orthodontics, (8) 
no outstanding or previous periodontal problems, (9) no 
removable prostheses, (10) no medication use with 
movement disorders as known side effects, (11) ability 
to follow instructions, (12) ability to report to the clinical 
laboratory at appointed times over the course of the 
study. The presence or absence of TMD joint noises or 
N=70; 1 month 
 
N=2 
N=4 
N=64; 3 & 6 mo 
N=6 
N=58 
Fig. 1. Estimated recruitment, enrollment, attrition 
and analysis numbers. 
masticatory myalgia will be permitted; however, joint arthritides will not be permitted. 
 
3.2 Project design. 
Fig. 2 provides an overview of the project flow. Each aspect will be described below. 
 
3.2.1 Screening. Candidates will undergo a screening to assess co-morbidities and to identify inclusion 
and  exclusion  criteria.  Standard  questionnaires  and  screening  instruments  include  the  Research 
Tx 
SOVA 
MI BS 
N 
29 
29 

 
 
 
Page 3 
 
 
1,  Screening (Day 1) 
IC & baseline questionnaires 
Baseline impressions 
Randomize group assignments 
2. Splint delivery (Day 8) 
Fabricate SOVA under supervision 
Deliver MI splint 
Evaluate stability 
Loan EMG equipment 
3. 1 wk splint wear (Nights 8-14) 
Record EMG nights 8, 14 
4. 1 wk check-up (Day 15) 
Assess stability, bite, retention tissue health, satisfaction 
Return EMG equipment 
Dismiss subject for 4 months 
5. 4 month checkup (~Day135) 
Assess stability, bite, retention tissue health, 
satisfaction, wear 
Loan EMG equipment 
6. 1 wk splint wear (~Nights 136-142) 
Record EMG first and last night 
7. End (~Day 143) 
Return EMG equipment, splint 
Subject debriefing and release from study 
Fig. 2. Overview of planned studies (see text). 
 
 
Diagnostic Criteria for TMD (TMD-RDC) (Dworkin and LeResche, 1992), Jaw Function Limitation Scale 
(JFLS) (Ohrbach et al., 2008), the TMD Pain Screener 
(Gonzalez et al., 2011), Measure of Symptoms Sleep 
Scale 
(MOS), 
Perceived 
Stress 
Scale 
(PSS). 
Additionally, a brief clinical exam will be performed to 
evaluate dental and medical health, including an intra- 
oral and extra-oral head and neck examination, heart 
rate and blood pressure. Subjects meeting the 
acceptance criteria will be randomly assigned to one of 
the two groups (Table 1) using stratified randomization 
procedures (Suresh, 2011). Subjects will then have 
alginate impressions taken, and impressions will be 
poured up in stone. The models will be used either to 
fabricate the MI BS or to assess SOVA appliances for 
fabrication efficacy. 
 
3.2.3. Splint delivery. For the SOVA group, subjects 
will be asked to fabricate SOVA devices in the clinical 
laboratory while receiving feedback from trained and 
calibrated study ‘instructors’. Fabrication will proceed 
according to manufacturer instructions. Calibrated 
instructors will be blinded to the study’s objectives, as 
will subjects. A “Michigan” acrylic bite splint will be 
fabricated using standard clinical practice and checked 
for fit and quality on subjects assigned to the MI BS 
group. 
3.2.4 
Subjective 
fabrication 
assessment. 
Standardized questionnaires will be provided to 
participants and will cover issues of ease of fabrication, 
ease of instructions, and other related issues for the 
devices. Box scales will be used to evaluate items 
individually and separately. 
3.2.5 Quantitative fabrication assessments. Four aspects of fabrication will be evaluated by 
investigators: (1) stability—does the device move independently of the maxilla and is the mandible 
stabilized by the device, (2) retention—does the device resist displacement, (3) tissue adaptation—how 
much spacing exists between the maxilla and the device and between the device and mandible, and (4) 
health of the teeth, gingival, tongue, palate and lips. 
3.2.5a. Stability and retention will be quantitatively assessed with jaw movement (custom jaw tracking 
devices in conjunction with a MaxTraq motion analysis system [Innovision, Columbiaville, MI] and EMG 
[LabChart, ADInstruments, Colorado Springs, CO] data) and force sensors (T-scan, Tektronix, South 
Boston, MA). For position-stability assessment, maxilla, mandible and the splint will be simultaneously 
recorded from at least three sites each (to capture 6 degrees of movement freedom). Subjects will clench, 
grind, perform closed border movements and vacuous chewing (verified with EMG and force sensors). 
For retention assessment, subjects will perform a series of tests designed to dislodge the device, e.g., 
tapping, forced blowing, coughing, chewing on gum. Stability and retention indices will be created based 
on whether device movements vary independently of jaw movements and applied bite forces, and how 
force sensor output varies during dislodgement exercises. (Note, the force sensors will be  placed 
between the device and the maxilla, so that reductions in sensor output will indicate that the device is 
being dislodged.) Deviations will be used to form standardized indices of stability and retention, with 
smaller values representing greater stability and retention. 
 
3.2.5b. Tissue adaptation will be assessed by using a 3D laser scanner. The occlusal, facial and lingual 
surfaces of the upper arch will be scanned as will the inner surface of the night guards. An index of 

 
 
 
Page 4 
 
 
 
 
adaptation will be developed based on the volumetric spaces separating the teeth from the device, using 
topological software. Smaller volumes will represent better tissue adaptation. Volumetric indices will be 
compared between devices via ANOVA or appropriate statistical methods. 
3.2.5c Tissue health will be assessed via appropriate, standard methods currently used in cariology and 
periodontology clinical studies (Monse et al., 2012; Tirapellia et al., 2010). Baseline measurements will be 
compared with post-device wear measurements. Between-group differences will be studied with a 
repeated measures ANOVA or appropriate statistical methods. 
 
3.2.6 Compliance assessment. Compliance assessments will focus on: (1) how often the device is worn, 
(2) whether the device is removed at inappropriate times during the night, (3) whether alternative devices 
are used. Compliance will be assessed via subject self-report (daily log), nocturnal EMG recording 
devices and microwear methods. Subjects would be blinded to the purpose of the technological methods. 
Occlusal microwear patterns are unique to the surfaces against which occlusion occurs, and the 
microwear changes on a daily basis (Ungar et al., 2003). Hence, microwear assessment provides 
definitive evidence regarding splint compliance. 
3.2.7 Functional efficacy. Two questions will be addressed under functional efficacy: (1) does the device 
alter bruxing activity, and (2) how do the teeth and device hold up under bruxing activity. Some of the 
technology used for compliance assessment, above, can be used here. ‘Gold standard’ methods for 
evaluating bruxing activity rely on polysomnography (PSG) and EMG activity; therefore, it will be 
important to employ these technologies for purpose of peer-review publications. To address the second 
question, how do the teeth hold up, 3-D laser scanning technology will be used to measure changes in 
macroscopic tooth structure, and confocal microscopy and scale-sensitive fractal analysis will be useful 
for addressing microwear. 
3.2.8 User satisfaction. This will be assessed through a series of standardized questionnaires adopted 
from other clinical studies, e.g., the Oral Health Impact Profile (Slade and Spencer, 1994), the Tampa 
Scale for Kinesiophobia: TMD (Visscher et al., 2010), the TMD pain screener (Gonzalez et al., 2011). 
Questionnaires used in the SISU field tests (SISU mouthguards preliminary results), as well as forced 
choice, box scales and statistical methods developed in another study (Lin, 2008; Lin et al., 2013) will 
also prove useful for assessment of patient satisfaction. Also such questions as, does the device hurt or 
pinch anywhere, does your bite feel ‘off’ when you first remove the guard, how often do you take out the 
splint before the night is over, do you experience excessive salivation or dry mouth, do you ever wake up 
with the splint out for unknown reasons, does the device build up plaque and other deposits through time, 
do you ever just feel like not wearing it and if so why not, will be used to assess specific aspects of user 
satisfaction. 
Table 2. Summary of objectives, methods and when performed 
Assessment 
Method or modality (equipment) 
When 
Subjective fabrication 
Questionnaires (na) 
Step 2 
Stability 
Performance during jaw function, bite force and muscle 
use (MaxTraq + EMG + T-Scan) 
Steps 2, 4, 5 
Retention 
Tissue adaptation 
Shape conformity (3-D laser scanner, topology) 
Steps 4,5 
Tissue health 
Tooth wear and gingival health (standard dental) 
Steps 4,5,6 
Compliance 
Self-report (questionnaires), Evidence of nocturnal use 
(EMG-sleep + microwear) 
Functional efficacy 
Bruxism/TMD evidence, dental changes (EMG-sleep + 3- 
D scanning + microwear) 
User satisfaction 
Questionnaires (na) 
 
3.2.9 Repeated measures (Step 4 Week 1 check-up and Step 5 4 Month check-up). Compliance, 
stability, retention, tissue adaptation and health, functional efficacy and user satisfaction will be assessed 
two times, viz., 1 week after delivery and 4 months after delivery (Fig. 2, Table 2). This will provide a 

 
 
 
Page 5 
 
 
 
 
rigorous data set, reduce subject attrition and thus allow for both publications and further proposal 
applications to be pursued. 
 
4. STATEMENT OF COLLABORATION AND TIMELINE OF ACTIVITIES 
Table 3. Timeline 
 
 
 
 
 
 
Table 3 estimates the timeline for the proposed studies. Each cell represents one month, with years 
being stratified into trimesters (Spring/summer, Fall, Winter). Based on clinical studies performed on TMD 
subjects at MICHR and current projects assessing jaw function, I estimate that screening can be 
completed in 14 months. Actual participation can begin upon receiving IRB approval and identification of 
appropriate candidates. Studies involve subjects for 6 months. Accounting for lag times involved in 
stratified randomization, enrollment will probably lag by 1-4 months, indicating that studies will wrap up 
after 2 years as shown, with enrollment finalized by early fall of the 2nd year, and all follow-ups being 
completed during the Winter of the 2nd  year. The final trimester will be heavily devoted to analysis and 
publication. Obviously, preliminary analyses (not shown) will begin as soon as data are available 
(approximately mid-Fall of year 1) in order to assure that experimental procedures are ideal 
PI Gerstner has a long-standing collaboration with Dr. Tom Braun, a biostatistician with MICHR, and he 
has published papers, served on graduate student MS committees and taught in courses with Dr. Braun. 
Statistical aspects of this project can be handled through this collaboration. PI Gerstner has also 
collaborated with Dr. Daniel Clauw’s chronic pain group, Dr. Shih’s mechanical engineering group and 
movement science groups in the School of Kinesiology. Any and all of these collaborations can be 
brought to bear on this project to move it forward with scientific rigor and state-of-the-art methods. 
5. BUDGET 
Personnel 
No personnel costs are being requested. The project will be carried out by dental students in the 
Pathways program of the school of dentistry and undergraduate pre-dental students who will be earning 
course credit. In this way, these costs can be curtailed. 
Equipment 
Funds are being requested for a sleep monitoring system (Biocapture, EMG sleep system) in order to 
evaluate compliance and efficacy issue (Table 2). The system monitors polysomnographic (PSG) 
variables to confirm sleep and bruxing events and is a clinical research standard and necessity. The 
system is critical for evaluating the night guard for compliance and functional efficacy in the home 
environment. No such system current exists in the Gerstner laboratory. 
 
Amplifiers and jaw tracking system upgrades are being requested for evaluation of bite splint stability and 
retention in the controlled laboratory setting (Table 2). The EMG system to which the amplifiers will be 
attached, will be purchased through other funding mechanisms in order to reduce costs to Delta Dental. 
Funds for the jaw tracking system represent an upgrade to an existing system; the upgrade will automate 
the analysis. The automation is critical, because it will allow students to do the data acquisition; otherwise 
non-automated analysis requires trained experts, which would require substantial personnel costs. 
 
Funds are being requested for a T-scan bite-force analysis system. This system, currently unavailable in 
the Gerstner laboratory, is the only system in existence that can reliably and quantitatively check how 
intra-oral forces impact stability and retention of the splint. Without this system, these aspects of the 
project would be difficult if not impossible to do. 
Task 
Sp/Su 
F 
W 
Sp/Su 
F 
W 
IRB 
Screening and recruitment 
Splint fabrication and first week 
Follow-up 4 months 
Analysis and Publication 

 
 
 
Page 6 
 
 
 
 
 
All equipment and upgrade prices reflect 20% academic price reductions. 
 
Supplies 
Funds are being requested to purchase software to analyze tooth and bite splint wear, which are critical 
for evaluating tissue health, compliance and functional efficacy. The prices reflect large academic price 
reductions. Laboratory fees are needed for fabrication of the Michigan bite splints necessary for the “gold 
standard” control group of subjects. The microscope provides an essential and inexpensive means of 
quality-screening the microwear on stone models before they are shipped for analysis with the confocal 
microscope (see Other Expenses, below). The use of an inexpensive microscope in the Gerstner 
laboratory will effectively reduce the costs of the latter analysis by over $2000, thus reducing budget costs 
by at least $1700. 
Other software as well as dental and technical supplies (> $19,000 worth), which are necessary for 
successful completion of the project, will be purchased through other funding sources. 
Other Expenses 
Subject fee expenses have been calculated as $20 per visit. As Fig. 1 shows, we estimate that 70 
subjects will finish the first appointment. After accounting for dropouts, we estimate that 64 will finish the 
next two appointments. Hence the fees are calculated as shown on the budget page. 
Confocal microwear processing fees are requested. These fees reflect a negotiated $45 / subject rate, 
and since these microwear processing can be done after other analyses, we can target only those 58 
subjects that will be included in the final analysis (Fig. 1, bottom). The processing is necessary to 
evaluate and fulfill the compliance and functional efficacy aspects of the project. 
 
Indirect costs have been figured based on the modified total direct cost rate (i.e., less equipment) and at 
8% as per Delta Dental Foundation’s ICR. 
6. REFERENCES 
ADA report. Using mouthguards to reduce the incidence and severity of sports-related oral injuries. 
(2006). Journal of the American Dental Association 137:1712–1720. 
Centers for Disease Control and Prevention. Promoting oral health: interventions for preventing dental 
caries, oral and pharyngeal cancers, and sports-related craniofacial injuries. A report on 
recommendations of the task force on community preventive services. (2001). MMWR Recomm Rep 50 
(21):1-13. 
Cunha-Cruz J, Pashova H, Packard JD, Zhou L, Hilton TJ (2010). Tooth wear: prevalence and associated 
factors in general practice patients. . Community Dentistry & Oral Epidemiology 38 (228-234. 
Dworkin SF, LeResche L (1992). Research diagnostic criteria for temporomandibular disorders: review, 
criteria, examinations and specifications, critique. Journal of Craniomandibular Disorders 6 (4):301-355. 
Fricton J, Look JO, Wright E, Alencar Jr. FGP, Chen H, Lang M et al. (2010). Systematic Review and 
Meta-analysis of Randomized Controlled Trials Evaluating Intraoral Orthopedic Appliances for 
Temporomandibular Disorders. Journal of Orofacial Pain 24 (237-254. 
Gonzalez YM, Schiffman E, Gordon SM, Seago B, Truelove ET, Slade G et al. (2011). Development of a 
brief and effective temporomandibular disorder pain screening questionnaire: reliability and validity. . 
Journal of the American Dental Association 142 (1183-1191. 
Huynh N, Manzini C, Rompré P, Lavigne GJ (2007). Weighing the Potential Effectiveness of Various 
Treatments for Sleep Bruxism. Journal of the Canadian Dental Association 73 (8):727-730b. 

 
 
 
Page 7 
 
 
 
 
Klasser GD, Greene CS, Lavigne GJ (2010). Oral Appliances and the Management of Sleep Bruxism in 
Adults: A Century of Clinical Applications and Search for Mechanisms. International Journal of 
Prosthodontics 23 (453-462. 
 
Lin AI-C (2008). Smile esthetics: evaluating smile esthetics through attention to facial muscular actvity. 
Ann Arbor, University of Michigan. 
 
Lin AI, Braun T, McNamara Jr JA, Gerstner GE (2013). Esthetic evaluation of dynamic smiles with 
attention to facial muscle activity. American Journal of Orthodontics and Dentofacial Orthopedics 143 
(6):819-827. 
Maeda Y, Kumamoto D, Yagi K, Ikebe K (2009). Effectiveness and fabrication of mouthguards. Dental 
Traumatology 25 (556-564. 
Monse B, Duijster D, Sheiham A, Grijalva-Eternod CS, van Palenstein Helderman W, Hobdell MH (2012). 
The effects of extraction of pulpally involved primary teeth on weight, height and BMI in underweight 
Filipino children. A cluster randomized clinical trial. BMC Public Health 12 (725. 
Ohrbach R, Larsson P, List T (2008). The jaw functional limitation scale: development, reliability, and 
validity of 8-item and 20-item versions. Journal of Orofacial Pain 22 (219-230. 
 
Rehm DDS, Mainieri VC, Saueressig AC, Grossi PK, Teixeira ER, Tenenbaum HC et al. (2012). Effects of 
the bite splint 15-day treatment termination in patients with temporomandibular disorder with a clinical 
history of sleep bruxism: a longitudinal single-cohort study. Oral Surgery Oral Medicine Oral Pathology 
Oral Radiology 114 (6):740-748. 
 
SISU mouthguards preliminary results. Ann Arbor. 
 
Slade G, Spencer J (1994). Development and evaluation of the Oral Health Impact Profile. Community 
Dental Health 11 (3-11. 
Suresh KP (2011). An overview of randomization techniques: An unbiased assessment of outcome in 
clinical research. Journal of Human Reproductive Sciences 4 (1):8-11. 
Tirapellia C, Landib F, Ribasa JP, Panzeria H, Lara EHG (2010). Evaluating an Experimental Dentifrice 
Containing Chloramine-T: A Preliminary Study. Oral Health and Preventative Dentistry 8 (375-381. 
 
Ungar PS, Brown CA, Bergstrom TS, Walker AC (2003). Quantification of dental microwear by tandem 
scanning confocal microscopy and scale-sensitive fractal analyses. . Scanning 25 (185-193. 
 
Visscher C, Ohrbach R, van Wijk A, Wilkosz M, M N (2010). The Tampa Scale for Kinesiophobia for 
Temporomandibular Disorders (TSK-TMD). Pain 150 (3):492-500.