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

NCT01754740 | Completed

• 1 other identifier: 12345
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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).

Conditions

Burning Mouth Syndrome

Keywords

Xerostomia, Salivary flow, Burning Mouth Syndrome.

Outcome Measures

Primary Outcomes (1)

• The role of Xerostomia in Burning Mouth Syndrome: case - control study

  three years

Study Arms (2)

Study Group

EXPERIMENTAL

19 patients whom received topical medication of urea 10%

Drug: Uréia

Control Group

PLACEBO COMPARATOR

19 patients whom received placebo

Drug: Placebo

Interventions

Uréia DRUG

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.

Also known as: ureia 10%

Study Group

Placebo DRUG

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.

Control Group

Eligibility Criteria

• Age: 37 Years - 88 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Hospital das Clinicas, Medical Scholl, University of Sao Paulo

São Paulo, São Paulo, 05403-010, Brazil

Location

MeSH Terms

Conditions

Burning Mouth Syndrome; Xerostomia

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Salivary Gland Diseases

Study Officials

• Silvia RDT Siqueira, Professor

  University of Sao Paulo

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2012
• First Posted: December 21, 2012
• Study Start: January 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: April 1, 2012
• Last Updated: December 21, 2012

Record last verified: 2012-12

Locations

BR (1)