Back to resultsImpact of Diazepam 1% Oral Gel Efficacy in Burning Mouth Syndrome
Primary Purpose
Burning Mouth Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Diazepam 1% oral gel
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Burning Mouth Syndrome
Eligibility Criteria
Inclusion Criteria: clinically diagnosed with BMS who reported a history of continuous oral burning pain for more than 4 months with no clinical signs that could justify the syndrome Exclusion Criteria: • clinically diagnosed with BMS who reported a history of continuous oral burning pain for more than 4 months with no clinical signs that could justify the syndrome
Sites / Locations
- AOU Policlinico G. RodolicoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Diazepam 1% Oral gel
Placebo
Arm Description
Patients were treated with Diazepam 1% oral gel.
Patients treated with a placebo gel control.
Outcomes
Primary Outcome Measures
Evolution of burning mouth
Evolution of burning mouth symptoms change through questionnaries. The Visual Pain Analog Scale (VAS) will be used to assess pain, in which the value 0 indicates no pain and the value 100 maximum pain. The Oral Health Impact Profile Short Form (OHIP-14) will be used to assess the impact of oral problems on quality of life, in which the presence or absence of physical pain, functional limitation, psychological distress, physical, psychological and social disabilities, and handicap will be assessed.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05872789
Brief Title
Impact of Diazepam 1% Oral Gel Efficacy in Burning Mouth Syndrome
Official Title
Impact of the Efficacy of Diazepam 1% Oral Gel in Burning Mouth Syndrome: an RCT Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
September 12, 2023 (Anticipated)
Study Completion Date
September 20, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Catania
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Burning mouth syndrome (BMS) is a syndrome characterized by burning and persistent oral pain, ranging from mild to intense, in the absence of organic disorders of the oral cavity and with a major impact on the quality of life of the sufferer. Although several etiological theories have been proposed to explain BMS, none has been universally accepted to date, and its origin remains unclear. Currently, several scientific evidences would suggest that underlying BMS would be alterations in certain neuropathic mechanisms.
The purpose of the study is to evaluate the efficacy of Diazepam 1% oral gel in the treatment of burning mouth syndrome.
Detailed Description
A double-blind placebo-controlled trial is conducted in order to evaluate the efficacy of Diazepam 1% oral gel and determine the statistical significance of the outcome variables. 40 patients with BMS, in two groups:
case group with Diazepam 1% oral gel (Galenic formulation)
control group with placebo in oral gel formulation
Follow-up of 2 months
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burning Mouth Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The main objective of this study was to evaluate the efficacy of Diazepam 1% oral gel over placebo in the management of BMS
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Diazepam 1% Oral gel
Arm Type
Experimental
Arm Description
Patients were treated with Diazepam 1% oral gel.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients treated with a placebo gel control.
Intervention Type
Drug
Intervention Name(s)
Diazepam 1% oral gel
Intervention Description
Diazepam 1% used with topic oral gel on tongue and palate twice daily.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo oral gel used on tongue and palate twice daily.
Primary Outcome Measure Information:
Title
Evolution of burning mouth
Description
Evolution of burning mouth symptoms change through questionnaries. The Visual Pain Analog Scale (VAS) will be used to assess pain, in which the value 0 indicates no pain and the value 100 maximum pain. The Oral Health Impact Profile Short Form (OHIP-14) will be used to assess the impact of oral problems on quality of life, in which the presence or absence of physical pain, functional limitation, psychological distress, physical, psychological and social disabilities, and handicap will be assessed.
Time Frame
2 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
clinically diagnosed with BMS who reported a history of continuous oral burning pain for more than 4 months with no clinical signs that could justify the syndrome
Exclusion Criteria:
• clinically diagnosed with BMS who reported a history of continuous oral burning pain for more than 4 months with no clinical signs that could justify the syndrome
Facility Information:
Facility Name
AOU Policlinico G. Rodolico
City
Catania
ZIP/Postal Code
95124
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gaetano PG Isola
Phone
0953785652
Email
gaetano.isola@unict.it
First Name & Middle Initial & Last Name & Degree
Rosalia Leonardi
Email
rleonard@unict.it
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Time Frame
1 year
IPD Sharing Access Criteria
Pubmed
Learn more about this trial
Impact of Diazepam 1% Oral Gel Efficacy in Burning Mouth Syndrome
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