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rev port estomatol med dent cir maxilofac . 2020;61(2):45-51 47

Over recent years, the industry has evolved toward produc- was conducted in full compliance with the World Medical As-
ing more portable and friendlier CES devices. GrindCare sociation Declaration of Helsinki and its most recent amend-
(GrindCare, Medotech A/S, Denmark) consists of a biofeedback ments, following the approved clinical practice guidelines.
device capable of measuring electromyography (EMG) activity When accepted into the study, patients were randomly al-
of the anterior temporalis muscle, by emitting a painless elec- located to Group I or Group II by a computer -generated ran-
trical pulse to the temporal region when EMG activity exceeds domization software (GraphPad Quick -Calcs website: http://
the individually determined threshold. 14 www.graphpad. com/quickcalcs/randomize1.cfm). The code
The aim of this randomized clinical trial was to evaluate for randomization was kept in a sealed envelope and opened
the effect of 4 - and 8 -week treatment protocols with CES on only at the end of the study. Data were analyzed by a third
pain symptoms, EMG activity (in the anterior temporalis mus- party blinded to the allocation results, which were referred to
cle), and threshold intensity when grinding (per night) on SB as treatment I or II in the SPSS worksheet (SPSS, Inc., Chicago,
patients with myofascial pain. IL, USA). The medical record was assessed by a single trained
and calibrated researcher according to previously established
methods (Dworkin and LeResche 1992 – RDC -TMD 1992).
Material and Methods The study workflow is shown in Figure 1 (Group I – 4 -week
CES and Group II – 8 -week CES). EMG of the anterior tempora-
A single -center, randomized, two -arm, parallel clinical trial lis muscle was monitored daily over the first 8 weeks of the
was performed. This study employed a sample of 48 volun- follow -up period to evaluate the short -term effect, and then
teers recruited according to previously established inclusion at 6 months (7 consecutive nights) to evaluate the long -term
and exclusion criteria (Table 1) at the clinic of the Faculty of effect. Patients were instructed to complete a diary designed
Dental Medicine of the University of Lisbon. The ethical com- to assess sleep quality and symptomatology according to: i)
mittee of this institution approved the study protocol, which level of pain (numerical rating scale [NRS] classification from

Table 1. Inclusion and exclusion criteria.
Pre ‑Inclusion Criteria
• 18 years of age or older;
• Patients diagnosed with sleep bruxism (based on AASM 2001);
• Score higher than 3 on a numerical rating scale (NRS) concerning pain during the baseline period.
Final Inclusion Criteria

• Signed and dated informed consent declaration;
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• More than 19 episodes of bruxism / hourly events per night, measured with GrindCare Medotech A / S (Denmark).
Exclusion Criteria
• Concomitant illnesses or general conditions which could contraindicate participation in the trial;
• Pacemaker;
• Parallel participation in other pharmaceutical or medical device trials;
• Daily use of pain relief medication (>1 a week), such as hypnotics, muscle relaxants, anxiolytics, analgesics, preventative medication
against chronic tension, and headache and migraine medication;
• Patients using mouth guards before the trial period;
• Pregnant and breastfeeding women;
• Alcohol and/or narcotic drug abuse;
• Documented or suspected localized irritation caused by electrode gel.

Figure 1. Study Design