The Role of Xerostomia in Burning Mouth Syndrome: Case - Control Study
Condition: Burning Mouth Syndrome
MeSH terms: Xerostomia; Burning Mouth Syndrome; Syndrome; Burns
Study type: Interventional

Summary: 
      Objectives: to evaluate xerostomia and salivary flow in patients with burning mouth syndrome
      (BMS) treated with amitriptyline before and after the use of antixerostomic topical
      medication.

      Methods: In this case-control double-blinded study, we enrolled 38 patients with BMS
      diagnosed according to the (IASP). The subjects were randomly divided into two groups: Study
      Group: 19 patients whom received topical medication of urea 10% and Control Group: 19
      patients whom received placebo to apply at the oral cavity 3-4 times per day, during three
      months. The patients were evaluated before and after the above treatment. Finally, data were
      statistically analyzed.

      It is know that BMS is eventually associated to reduced salivary flow (Cho et al.,2010; Kho
      et al., 2010; Marino et al., 2010) and to abnormal salivary composition (increasing
      concentrations of K+, Na+, Cl-, Ca+2, IgA, amylase) (Patton et al., 2007). Even in the
      absence of hyposalivation, patients may complain of xerostomia and dry mouth (Cho et
      al.,2010; Kho et al., 2010; Marino et al., 2010; Thomson, 2005). These patients also have
      several sensory losses even in taste and smell function, recently described (Siqueira et al.,
      2006a; Siqueira et al., 2006b; Siviero et al., 2011).
    

Detailed description: 
      Materials and Methods In this case-control double-blinded study, we enrolled 38 patients with
      BMS diagnosed according to the International Association for the Study of Pain (IASP) (17),
      that had been followed at the Craniofacial Pain Clinic of Hospital das Clinicas, School of
      Medicine of the University of Sao Paulo. All subjects were informed about the purposes of the
      study, and all signed the informed consent. The protocol had been approved by the local
      Ethics Committee. No patient had hyposalivation at the moment of diagnosis by the
      quantitative evaluation. All patients had been treated with 25mg-50mg of amitriptyline within
      the last three months. They underwent laboratory tests and careful exam to exclude other
      causes of burning mouth (10).

      The exclusion criteria were other facial pain syndromes, other causes for abnormal
      salivation, other neuropathies or primary diseases associated to burning mouth, inability to
      answer the questions and / or tests

      The subjects were randomly divided into two groups:

        1. Study Group: 19 patients received topical medication of urea 10% to be applied at the
           oral cavity 3-4 times per day, during three months.

        2. Control Group: 19 patients received placebo (5% sodium carboxymethylcellulose, 0.15%
           methyl paraben and 10% glycerol in distilled water qsp 100g) to be applied at the oral
           cavity 3-4 times per day, during three months.

      The patients were evaluated before and after the above treatment with the following
      instruments:

        1. EDOF-HC protocol (Orofacial Pain Clinic - Hospital das Clinicas): a standardized
           orofacial pain questionnaire to detail: 1) chief complaint, 2) general pain
           characteristics (location, quality, duration, pain relief, pain triggering), 3) headache
           and/or body pain complaints, and 4) patient's medical history and co-morbidities
           (18,19);

        2. Xerostomia questionnaire (20);

        3. Quantitative sensory testing. All subjects underwent a standardized protocol of
           quantitative sensory testing (QST) (21) which consists of twelve tests grouped as
           follows:

             -  salivary flow; gustative and olfactory thresholds;

             -  thermal detection thresholds for cold and warm sensations;

             -  mechanical detection thresholds for touch, vibration and electrical perception;

             -  mechanical pain sensitivity including superficial and deep pain thresholds;

             -  electric pain threshold at the teeth.

             -  corneal reflex.
    

Intervention name(s): Uréia; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): The subjects were randomly divided into two groups:
1. Study Group: 19 patients received topical medication of urea 10% to be applied at the oral cavity 3-4 times per day, during three months.; Control Group: 19 patients received placebo (5% sodium carboxymethylcellulose, 0.15% methyl paraben and 10% glycerol in distilled water qsp 100g) to be applied at the oral cavity 3-4 times per day, during three months.
Other intervention name(s): ureia 10%
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Xerostomia, Salivary flow, Burning Mouth Syndrome.