Burning Mouth SyndromeTOP-AMI → TOPiNCT07214181
Topical Amitriptyline 1% Gel for the Treatment of Burning Mouth Syndrome
An observational study of Burning Mouth Syndrome and Stomatodynia, run by Universidad de Murcia at 1 site in Spain.
Trial summary
Burning mouth syndrome (BMS) is a chronic oral pain condition that causes a persistent burning or stinging sensation in the mouth, often without visible changes in the tissues. It mostly affects women in midlife and older age and can greatly reduce quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burning Mouth Syndrome, Stomatodynia
- What is being tested?
- Topical amitriptyline 1% gel
- Type of treatment
- Pill or oral medicine
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 2 Jan 2024to 30 May 2025
- How long will I take part?
- 4 Weeks
- Phase
- Observational
- 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 years and older
- All sexes
- Adult, Older adult
Study population: This retrospective study included adult patients diagnosed with burning mouth syndrome (BMS) according to international diagnostic criteria. All patients received topical amitriptyline 1% gel as part of routine clinical care and had complete medical records with baseline and 4-week follow-up data available for analysis.
Who may be able to join
- Adult patients diagnosed with burning mouth syndrome (BMS) according to international diagnostic criteria (ICHD-3 and ICOP).
- Symptoms recurring daily for >50% of the day for at least 3 months.
- Pain intensity ≥4 on a 0-10 numerical rating scale (NRS) at baseline.
- Normal appearance of the oral mucosa and normal intraoral clinical examination.
- Received topical amitriptyline 1% gel as part of routine care.
Who cannot join
- Missing or incomplete medical records.Use of other concomitant topical treatments on the oral mucosa during the study period.
- Change in systemic pain medication while using topical amitriptyline gel.
- Presence of local conditions and sytemic that could cause burning mouth symptoms (e.g., candidiasis, lichen planus, allergies, ).
Trial locations and contacts
1 site in 1 country.
About this study
Burning mouth syndrome (BMS) is a chronic oral pain condition that causes a persistent burning or stinging sensation in the mouth, often without visible changes in the tissues. It mostly affects women in midlife and older age and can greatly reduce quality of life.
This study reviewed the medical records of patients with BMS who were treated with a topical 1% amitriptyline gel. The aim was to evaluate whether this gel could reduce pain and to record any side effects.
Read more
Patients applied the gel inside the mouth for several weeks. Pain intensity was measured using a 0-10 scale before and after treatment. We also collected information about patients' overall impression of improvement and any reported adverse events.
By analyzing these retrospective data, we hope to provide real-world evidence on the effectiveness and safety of topical amitriptyline gel as a potential treatment option for patients with burning mouth syndrome.
Read the detailed description
Burning mouth syndrome (BMS) is a chronic oral pain condition that causes a persistent burning or stinging sensation in the mouth, often without visible changes in the tissues. It mostly affects women in midlife and older age and can greatly reduce quality of life.
This study reviewed the medical records of patients with BMS who were treated with a topical 1% amitriptyline gel. The aim was to evaluate whether this gel could reduce pain and to record any side effects.
Patients applied the gel inside the mouth for several weeks. Pain intensity was measured using a 0-10 scale before and after treatment. We also collected information about patients' overall impression of improvement and any reported adverse events.
By analyzing these retrospective data, we hope to provide real-world evidence on the effectiveness and safety of topical amitriptyline gel as a potential treatment option for patients with burning mouth syndrome.
- Conditions
- Burning Mouth Syndrome, Stomatodynia
- Being tested
- Topical amitriptyline 1% gel
- Keywords
- pain , Amitriptyline ; treatment
- Medical subject headings
- Burning Mouth Syndrome, Stomatodynia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical amitriptyline 1% gelDrug
Patients diagnosed with burning mouth syndrome received topical amitriptyline 1% gel applied intraorally. The gel was instructed to be placed on the oral mucosa (tongue and/or other symptomatic areas) two times per day for several weeks, without swallowing. Treatment was provided as part of routine clinical care. This retrospective study collected data on pain intensity, patient global impression of improvement, and adverse events to evaluate the real-world effectiveness and tolerability of this topical formulation.
| Study group | Role | What they receive |
|---|---|---|
| This retrospective cohort includes patients diagnosed with burning mouth syndrome (BMS | Patients diagnosed with burning mouth syndrome (BMS) according to international diagnostic criteria who received treatment with topical amitriptyline 1% gel. Patients applied the gel intraorally for several weeks as part of routine clinical care. Data collected from medical records included pain intensity (0-10 numerical rating scale) before and after treatment, patient global impression of improvement, and reported adverse events. The cohort reflects real-world use of topical amitriptyline gel for BMS. Receives: Drug: Topical amitriptyline 1% gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Title: Change in mean pain intensity (NRS 0-10)
Description: Pain intensity measured using a numerical rating scale (0 = no pain, 10 = worst possible pain). Mean daily score calculated from patient records at baseline (before treatment) and after 4 weeks of topical amitriptyline gel.
Measured: Baseline to 4 weeks after treatment initiation
Secondary outcomes (1)
Patient Global Impression of Improvement (PGI-I)
Description: Patient-reported overall improvement, categorized as "very much better," "much better," "a little better," "no change," or "worse."
Measured: Time Frame: At 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2025
- Study start2 Jan 2024
- Primary completion30 Nov 2024
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 30 participants (actual)
- Target duration
- 4 Weeks
Sponsor and investigators
- Lead sponsor
- Universidad de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pia Lopez Jornet, Universidad de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07214181
- Sponsor's protocol ID
- C.I. EST: 53/25
- Acronym
- TOP-AMI → TOPi
- Status last verified
- Oct 2025
- First submitted
- 2 Oct 2025
- Last updated
- 9 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kung CP, Sil BC, Zhang Y, Hadgraft J, Lane ME, Patel B, McCulloch R. Dermal delivery of amitriptyline for topical analgesia. Drug Deliv Transl Res. 2022 Apr;12(4):805-815. doi: 10.1007/s13346-021-00982-x. Epub 2021 Apr 22.
PubMed 33886076Lebel A, Da Silva Vieira D, Boucher Y. Topical amitriptyline in burning mouth syndrome: A retrospective real-world evidence study. Headache. 2024 Oct;64(9):1167-1173. doi: 10.1111/head.14818. Epub 2024 Aug 23.
PubMed 39177013
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Amitriptyline 1% Gel for the Treatment of Burning Mouth Syndrome
- ClinicalTrials.gov ID
- NCT07214181
- Acronym / sponsor ID
- TOP-AMI → TOPi / C.I. EST: 53/25
- Conditions
- Burning Mouth Syndrome, Stomatodynia
- Keywords
- pain , Amitriptyline ; treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universidad de MurciaUniversity, hospital or other
- Study start
- 2 Jan 2024 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 9 Oct 2025 (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 chronic oral pain condition that causes a persistent burning or stinging sensation in the mouth, often without visible changes in the tissues. It mostly affects women in midlife and older age and can greatly reduce quality of life.
This study reviewed the medical records of patients with BMS who were treated with a topical 1% amitriptyline gel. The aim was to evaluate whether this gel could reduce pain and to record any side effects.
Patients applied the gel inside the mouth for several weeks. Pain intensity was measured using a 0-10 scale before and after treatment. We also collected information about patients' overall impression of improvement and any reported adverse events.
By analyzing these retrospective data, we hope to provide real-world evidence on the effectiveness and safety of topical amitriptyline gel as a potential treatment option for patients with burning mouth syndrome.
Detailed description
Burning mouth syndrome (BMS) is a chronic oral pain condition that causes a persistent burning or stinging sensation in the mouth, often without visible changes in the tissues. It mostly affects women in midlife and older age and can greatly reduce quality of life.
This study reviewed the medical records of patients with BMS who were treated with a topical 1% amitriptyline gel. The aim was to evaluate whether this gel could reduce pain and to record any side effects.
Patients applied the gel inside the mouth for several weeks. Pain intensity was measured using a 0-10 scale before and after treatment. We also collected information about patients' overall impression of improvement and any reported adverse events.
By analyzing these retrospective data, we hope to provide real-world evidence on the effectiveness and safety of topical amitriptyline gel as a potential treatment option for patients with burning mouth syndrome.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Target follow-up
- 4 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| This retrospective cohort includes patients diagnosed with burning mouth syndrome (BMS | – | Drug: Topical amitriptyline 1% gelPatients diagnosed with burning mouth syndrome (BMS) according to international diagnostic criteria who received treatment with topical amitriptyline 1% gel. Patients applied the gel intraorally for several weeks as part of routine clinical care. Data collected from medical records included pain intensity (0-10 numerical rating scale) before and after treatment, patient global impression of improvement, and reported adverse events. The cohort reflects real-world use of topical amitriptyline gel for BMS. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- This retrospective study included adult patients diagnosed with burning mouth syndrome (BMS) according to international diagnostic criteria. All patients received topical amitriptyline 1% gel as part of routine clinical care and had complete medical records with baseline and 4-week follow-up data available for analysis.
Key inclusion criteria (5 listed)
- Adult patients diagnosed with burning mouth syndrome (BMS) according to international diagnostic criteria (ICHD-3 and ICOP).
- Symptoms recurring daily for >50% of the day for at least 3 months.
- Pain intensity ≥4 on a 0-10 numerical rating scale (NRS) at baseline.
- Normal appearance of the oral mucosa and normal intraoral clinical examination.
- Received topical amitriptyline 1% gel as part of routine care.
Key exclusion criteria (3 listed)
- Missing or incomplete medical records.Use of other concomitant topical treatments on the oral mucosa during the study period.
- Change in systemic pain medication while using topical amitriptyline gel.
- Presence of local conditions and sytemic that could cause burning mouth symptoms (e.g., candidiasis, lichen planus, allergies, ).
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 |
|---|---|---|
| Topical amitriptyline 1% gelPatients diagnosed with burning mouth syndrome received topical amitriptyline 1% gel applied intraorally. The gel was instructed to be placed on the oral mucosa (tongue and/or other symptomatic areas) two times per day for several weeks, without swallowing. Treatment was provided as part of routine clinical care. This retrospective study collected data on pain intensity, patient global impression of improvement, and adverse events to evaluate the real-world effectiveness and tolerability of this topical formulation. | Drug | This retrospective cohort includes patients diagnosed with burning mouth syndrome (BMS |
Primary outcome
Title: Change in mean pain intensity (NRS 0-10)
Time frame: Baseline to 4 weeks after treatment initiation
Description: Pain intensity measured using a numerical rating scale (0 = no pain, 10 = worst possible pain). Mean daily score calculated from patient records at baseline (before treatment) and after 4 weeks of topical amitriptyline gel.
1 secondary outcome
Patient Global Impression of Improvement (PGI-I)
Time frame: Time Frame: At 4 weeks
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 9 Oct 2025.
- Results publication: PubMed 33886076Kung CP, Sil BC, Zhang Y, Hadgraft J, Lane ME, Patel B, McCulloch R. Dermal delivery of amitriptyline for topical analgesia. Drug Deliv Transl Res. 2022 Apr;12(4):805-815. doi: 10.1007/s13346-021-00982-x. Epub 2021 Apr 22.
- Results publication: PubMed 39177013Lebel A, Da Silva Vieira D, Boucher Y. Topical amitriptyline in burning mouth syndrome: A retrospective real-world evidence study. Headache. 2024 Oct;64(9):1167-1173. doi: 10.1111/head.14818. Epub 2024 Aug 23.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Burning Mouth Syndrome and Stomatodynia, run by Universidad de Murcia at 1 site in Spain.
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 5 inclusion and 3 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 9 Oct 2025. 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 Spain. 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. 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?
Title: Change in mean pain intensity (NRS 0-10) (time frame: Baseline to 4 weeks after treatment initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07214181, which also lists 2 linked publications.
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 9 Oct 2025.