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

NCT ID: NCT05872789

Last Updated: 2023-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-02

Study Completion Date

2023-10-20

Brief Summary

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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

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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

Conditions

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Burning Mouth Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Diazepam 1% Oral gel

Patients were treated with Diazepam 1% oral gel.

Group Type EXPERIMENTAL

Diazepam 1% oral gel

Intervention Type DRUG

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

Placebo

Patients treated with a placebo gel control.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo oral gel used on tongue and palate twice daily.

Interventions

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Diazepam 1% oral gel

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

Intervention Type DRUG

Placebo

Placebo oral gel used on tongue and palate twice daily.

Intervention Type DRUG

Eligibility Criteria

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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 clinical signs that could justify the syndrome
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Catania

OTHER

Sponsor Role lead

Responsible Party

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Gaetano Isola

Principal researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gaetano Isola

Role: PRINCIPAL_INVESTIGATOR

University of Catania

Locations

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AOU Policlinico G. Rodolico

Catania, , Italy

Site Status

Countries

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Italy

Other Identifiers

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121-24

Identifier Type: -

Identifier Source: org_study_id