Burning Mouth SyndromeNCT05872789
Impact of Diazepam 1% Oral Gel Efficacy in Burning Mouth Syndrome
A study testing Diazepam 1% oral gel in people with Burning Mouth Syndrome, run by University of Catania at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Burning Mouth Syndrome
- What is being tested?
- Diazepam 1% oral gel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 2 May 2020to 20 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- • 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of the Efficacy of Diazepam 1% Oral Gel in Burning Mouth Syndrome
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.
Read the 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
- Conditions
- Burning Mouth Syndrome
- Being tested
- Diazepam 1% oral gel, Placebo
- Medical subject headings
- Burning Mouth Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diazepam 1% oral gelDrug
Diazepam 1% used with topic oral gel on tongue and palate twice daily.
PlaceboDrug
Placebo oral gel used on tongue and palate twice daily.
| Study group | Role | What they receive |
|---|---|---|
| Diazepam 1% Oral gel | Experimental | Patients were treated with Diazepam 1% oral gel. Receives: Drug: Diazepam 1% oral gel |
| Placebo | Placebo comparator | Patients treated with a placebo gel control. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start2 May 2020
- Primary completion12 Sep 2023
- Study completion20 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burning Mouth SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Catania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gaetano Isola, University of Catania
- Investigators
- Gaetano Isola, Principal investigator, University of Catania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05872789
- Sponsor's protocol ID
- 121-24
- Status last verified
- Nov 2023
- First submitted
- 15 May 2023
- Last updated
- 1 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Efficacy of Diazepam 1% Oral Gel in Burning Mouth Syndrome
- ClinicalTrials.gov ID
- NCT05872789
- Acronym / sponsor ID
- 121-24
- Conditions
- Burning Mouth Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of CataniaUniversity, hospital or other
- Study start
- 2 May 2020 (actual)
- Primary completion
- 12 Sep 2023 (actual)
- Study completion
- 20 Oct 2023 (actual)
- First posted
- 24 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Diazepam 1% Oral gel | Experimental | Drug: Diazepam 1% oral gelPatients were treated with Diazepam 1% oral gel. |
| Placebo | Placebo comparator | Drug: PlaceboPatients treated with a placebo gel control. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- • 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diazepam 1% oral gelDiazepam 1% used with topic oral gel on tongue and palate twice daily. | Drug | Diazepam 1% Oral gel |
| PlaceboPlacebo oral gel used on tongue and palate twice daily. | Drug | Placebo |
Primary outcome
Evolution of burning mouth
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2023.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gaetano Isola principal investigator
University of Catania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diazepam 1% oral gel in people with Burning Mouth Syndrome, run by University of Catania at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of burning mouth (time frame: 2 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2023.