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Title There Is Insufficient Evidence For The Efficacy Of NuCalm Technology In Preventing/Treating Anxiety In Dental Patients
Clinical Question In an anxious patient needing operative and restorative procedures, does the NuCalm system prevent or reduce anxiety as perceived by the patient, compared to placebo?
Clinical Bottom Line Currently, no evidence stronger than patient and dentist testimonials is available regarding the combination of therapies provided in NuCalm. Regarding the individual components of the NuCalm package: weak evidence (one small cohort study evaluated in this CAT) exists supporting cranial electrostimulation for dental anxiety. No evidence directly addresses the use of blackout glasses, GABA-related dietary supplements, nor acoustic stimulation for dental anxiety. At this time we do not have adequate evidence with which to evaluate the NuCalm method. (See Comments on the CAT below)
Best Evidence (you may view more info by clicking on the PubMed ID link)
PubMed ID Author / Year Patient Group Study type
(level of evidence)
#1) 10321152Winick/199933 adult dental patients reporting dental anxiety, needing routine dental treatmentCohort Study (randomization uncertain)
Key resultsNote that this was a study on cranial electrotherapy stimulation only, not on the entire package of interventions in the NuCalm technology. Although the study examined both dentist and patient evaluations of patient anxiety, our PICO question asks only about patient evaluation. Patient evaluation of anxiety on the visual analog scale (VAS) did not differ between groups during the dental procedures: -5.6 (+/- 9.7 SEM) for active treatment, -2.8 (+/- 3.25) for sham treatment. Patient evaluation of anxiety on the VAS was significantly lower post-treatment for active treatment -30.1 (+/- 9.0) than for sham treatment -4.2 (+/- 3.9), p < 0.02. Patient evaluation of anxiety on the Likert scale was 4.8 (+/-0.04) for active treatment, significantly better than 2.5 (+/-0.3) for sham treatment (p < 0.01).
Evidence Search #80 Search (#52) AND #79 8
#79 Search (#77) OR #78 59691
#78 Search "Anxiety"[Mesh] 43402
#77 Search "Fear"[Mesh] 20657
#72 Search (#51) AND #71 0
#71 Search "Dietary Supplements"[Mesh] 25754
#69 Search #51 AND (#63 OR #64 OR #65) 0
#68 Search (#51) AND #59 0
#67 Search (#51) AND #56 2
#66 Search (#51) AND #52 2
#65 Search "sunglasses" OR "sun glasses" 316
#64 Search "blackout glasses" 0
#63 Search "Darkness"[Mesh] 10545
#59 Search (#57) OR #58 33417
#58 Search "theanine "[Substance Name] 110
#57 Search "gamma-Aminobutyric Acid"[Mesh] 33310
#56 Search "Acoustic Stimulation"[Mesh] 27643
#54 Search "Electric Stimulation"[Mesh] 108964
#52 Search cranial electrotherapy stimulation 415
#51 Search "Dental Anxiety"[Mesh] 1628
#50 Search nucalm
Comments on
The Evidence
No studies are available on the NuCalm package of treatments. The single study reviewed used cranial electrotherapy stimulation, only one of the components of the NuCalm approach. This cohort study (not clearly randomized) assigned 17 patients to active cranial electrotherapy stimulation and 16 patients to sham stimulation, double-blinded. Dental anxiety was evaluated with the visual analog scale (VAS) before, during, and after a dental appointment. All patients completed the study; because this was a one-appointment study per patient, follow-up and recall bias were not applicable. It is not clear that the two groups were similar at the start (different mean ages, different self-reported anxiety levels at the beginning) which weakens our confidence in the results. No competing interests were mentioned.
Applicability Keeping in mind the evidence reviewed is weak and does not directly address the original question, based on patient ages and dental needs, our average patients should have qualified for this study. The electrical stimulator used, although the particular model may no longer be available, seems to be feasible for general practice use. No harms reported in the study. Benefit: possible reduction in anxiety from electrical stimulation.
Specialty/Discipline (General Dentistry) (Behavioral Science)
Keywords anxiety, electrical stimulation, auditory stimulation, dietary supplements, NuCalm
ID# 746
Date of submission: 11/18/2010spacer
E-mail deahl@uthscsa.edu
Author S. Thomas Deahl, II, DMD, PhD
Co-author(s) UTHSCSA Dental Class of 2013
Co-author(s) e-mail
Faculty mentor/Co-author
Faculty mentor/Co-author e-mail
Basic Science Rationale
(Mechanisms that may account for and/or explain the clinical question, i.e. is the answer to the clinical question consistent with basic biological, physical and/or behavioral science principles, laws and research?)
post a rationale
None available
Comments and Evidence-Based Updates on the CAT
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by Michelle Clinton, Shantal White, Charlie Majdalani (San Antonio, TX) on 01/06/2014
There has been no new research done on the topic of NuCalm or the components of the NuCalm package with regards to dental anxiety. More research needs to be done on NuCalm that includes all methods of the NuCalm system to determine whether or not it is a useful system for patients with dental anxiety.

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