The Role of Xerostomia in Burning Mouth Syndrome: Case - Control Study (BMS)

• ClinicalTrials.gov Identifier: NCT01754740
• Recruitment Status: Completed
• First Posted: December 21, 2012
• Last Update Posted: December 21, 2012
• Sponsor: University of Sao Paulo General Hospital
• Information provided by (Responsible Party): University of Sao Paulo General Hospital

Study Description

Brief 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).

Condition or disease	Intervention/treatment	Phase
Burning Mouth Syndrome	Drug: Uréia; Drug: Placebo	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 38 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: The Role of Xerostomia in Burning Mouth Syndrome: Case - Control Study
• Study Start Date: January 2010
• Actual Primary Completion Date: March 2012
• Actual Study Completion Date: April 2012

Arms and Interventions

Arm	Intervention/treatment
Experimental: Study Group; 19 patients whom received topical medication of urea 10%	Drug: Uréia; 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.; Other Name: ureia 10%
Placebo Comparator: Control Group; 19 patients whom received placebo	Drug: Placebo; 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.

Outcome Measures

Primary Outcome Measures :

1. The role of Xerostomia in Burning Mouth Syndrome: case - control study [ Time Frame: three years ]

Eligibility Criteria

• Ages Eligible for Study: 37 Years to 88 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Contacts and Locations

Locations

Brazil

Hospital das Clinicas, Medical Scholl, University of Sao Paulo

Sao Paulo, Brazil, 05403-010

Sponsors and Collaborators

University of Sao Paulo General Hospital

Investigators

• Study Director: Silvia RDT Siqueira, Professor; University of Sao Paulo

More Information

• Responsible Party: University of Sao Paulo General Hospital
• ClinicalTrials.gov Identifier: NCT01754740
• Other Study ID Numbers: 12345
• First Posted: December 21, 2012
• Last Update Posted: December 21, 2012
• Last Verified: December 2012

Keywords provided by University of Sao Paulo General Hospital:

Xerostomia, Salivary flow, Burning Mouth Syndrome.

Additional relevant MeSH terms:

Xerostomia; Burning Mouth Syndrome; Syndrome; Burns; Disease; Pathologic Processes; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Wounds and Injuries