Impact of Diazepam 1% Oral Gel Efficacy in Burning Mouth Syndrome

Sponsor

University of Catania (Other)

Overall Status

Recruiting

CT.gov ID

NCT05872789

Collaborator

(none)

Enrollment

Location

Arms

42.6

Anticipated Duration (Months)

0.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Burning Mouth Syndrome	Drug: Diazepam 1% oral gel Drug: Placebo	N/A

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

The main objective of this study was to evaluate the efficacy of Diazepam 1% oral gel over placebo in the management of BMSThe main objective of this study was to evaluate the efficacy of Diazepam 1% oral gel over placebo in the management of BMS

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Impact of the Efficacy of Diazepam 1% Oral Gel in Burning Mouth Syndrome: an RCT Study

Actual Study Start Date :

Mar 1, 2020

Anticipated Primary Completion Date :

Sep 12, 2023

Anticipated Study Completion Date :

Sep 20, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Diazepam 1% Oral gel Patients were treated with Diazepam 1% oral gel.	Drug: Diazepam 1% oral gel Diazepam 1% used with topic oral gel on tongue and palate twice daily.
Placebo Comparator: Placebo Patients treated with a placebo gel control.	Drug: Placebo Placebo oral gel used on tongue and palate twice daily.

Arm

Intervention/Treatment

Experimental: Diazepam 1% Oral gel

Patients were treated with Diazepam 1% oral gel.

Drug: Diazepam 1% oral gel

Diazepam 1% used with topic oral gel on tongue and palate twice daily.

Placebo Comparator: Placebo

Patients treated with a placebo gel control.

Drug: Placebo

Placebo oral gel used on tongue and palate twice daily.

Outcome Measures

Primary Outcome Measures

Evolution of burning mouth [2 Months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AOU Policlinico G. Rodolico	Catania		Italy	95124

Sponsors and Collaborators

University of Catania

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Gaetano Isola, Principal researcher, University of Catania

ClinicalTrials.gov Identifier:

NCT05872789

Other Study ID Numbers:

121-24

First Posted:

May 24, 2023

Last Update Posted:

May 25, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Burning Mouth Syndrome

Syndrome

Burns

Diazepam

Study Results

No Results Posted as of May 25, 2023