ORPHA:353253
Burning mouth syndrome
Also known as: BMS · Oral dysesthesia · Orodynia · Stomatodynia · Stomatopyrosis
Publications
3,497
Trials
38
Interventional, condition-specific
Researchers
829
Distinct authors in sample
Gene link
—
Readiness
3/6
Stages with a signal
Clinical definition (Orphanet)
A rare neurologic disease characterized by an unremitting bilateral symmetrical burning sensation of the oral mucosa without clinical evidence of causative lesions. It most frequently occurs in postmenopausal women and typically affects the tongue, less often the palate, lips, or buccal mucosa. It is often associated with dysgeusia and xerostomia.
How rare: How common this is has not been clearly measured.
Cross-references
Joined from Mondo / Orphanet. MeSH labels may enter searches; UMLS / OMIM / NCIT are stored for reference.
- MONDO:0006687
- MeSH:D002054
- UMLS:C0006430
- NCIT:C62545
Additional Mondo synonyms (2)
oral dysesthesia · stomatodynia
Research stages
Trial readiness signals
Where this condition sits on an open-data research pipeline — not how close a treatment is, and not medical advice. Empty stages often mean “not in these databases under this Mondo ID,” not “impossible.”
3/6 stages with a signal
An interventional trial matched this condition name on ClinicalTrials.gov — see trials below.
- Gene identifiedNot found
No GenCC disease–gene assertion in this build
- LiteraturePresent
3,497 matched papers (2,107 in last 10 years) Source
- Phenotype characterisedPresent
17 HPO annotations (e.g. Abnormality of taste sensation; Anxiety; Depression) Source
- Animal modelNot found
No Alliance genotype “model of” associations via Monarch for these Mondo IDs
- Orphan designationNot found
No FDA or EMA orphan-drug designation matched this disease via UMLS or preferred name Source
- Interventional trialPresent
38 matched on ClinicalTrials.gov (4 recruiting in sample)
Biology
Genes and phenotypes
Gene–disease validity from GenCC, plus phenotypes and animal models joined from Monarch Initiative via Mondo ID — not a clinical diagnosis aid.
Do we know what causes it?
Not yet — the cause hasn't been pinned down in GenCC.
No strong gene–disease assertion joined for this Orphanet entity.
Phenotypes (Monarch / HPO)
17
Associated phenotypes · MONDO:0006687
- Abnormality of taste sensation
- Anxiety
- Depression
- Tongue pain
- Abnormality of the gingiva
Showing 5 of 17 — open Monarch for the full list.
Animal models (Monarch / Alliance)
None returned for this Mondo ID. Empty here is not proof that no model organism work exists under another name or gene.
Monarch fetch 2026-07-29
Therapies
Designations, candidates, and chemicals
FDA OOPD and EMA orphan designations, Open Targets clinical candidates, and CTD chemical associations via MyDisease.info. These never change the interventional-trial headline.
Orphan designation (FDA · EMA)
No designation matched this disease via UMLS or preferred name on the FDA OOPD mirror or EMA orphan register. Absence here is not proof that none exists under another wording.
Open Targets candidates
31
Drugs / clinical candidates · MONDO_0006687
- CITALOPRAM·phase 3
- CLONAZEPAM·phase 3
- DULOXETINE·phase 3
- ESCITALOPRAM·phase 3
- FERRIC CARBOXYMALTOSE·phase 3
- FERRIC OXYHYDROXIDE·phase 3
- FERROUS SULFATE·phase 3
- FOLIC ACID·phase 3
- IRON ISOMALTOSIDE 1000·phase 3
- PAROXETINE·phase 3
- PREGABALIN·phase 3
- SERTRALINE·phase 3
- VITAMIN B12·phase 3
- VORTIOXETINE·phase 3
- ZINC ACETATE·phase 3
CTD chemicals (MyDisease.info)
5 associated chemicals. Therapeutic evidence is listed first when present — not a treatment recommendation.
- Paroxetine · therapeutic
- candesartan · marker/mechanism
- Lamivudine · marker/mechanism
- Nevirapine · marker/mechanism
- Zidovudine · marker/mechanism
Literature
Is anyone studying this?
3,497
3,497 papers have been published on this condition. That is a real research literature — still far smaller than common diseases (breast cancer: over 700,000 papers). Median papers in the last 10 years for a rare disease in this dataset (publications denominator n=3967) is 59.
3,497 papers since the earliest indexed year in this search — median last-10-year count for a rare disease in this dataset is 59 (publications denominator n=3967).
2,107 in the last 10 years · low confidence
Phrase hits: 3,497 · MeSH hits: 147
Who's working on it?
829
Distinct author names in 200 sampled papers — named people below.
Who's working on it?
People publishing on this condition (sampled Europe PMC records). Affiliation is the most recent found in that sample.
- 01Nagamine T13 papers · 2026
Sunlight Brain Research Center, 4-13-18 Jiyugaoka, Hofu, Yamaguchi 747-0066, Japan. Electronic address: tnagamine@outlook.com.
Papers in Europe PMC - 02Adamo D11 papers · 2026
Department of Neuroscience, Reproductive and Odontostomatological Sciences, Oral Medicine Unit, University of Naples Federico II, Naples, Italy.
Papers in Europe PMC - 03Toyofuku A11 papers · 2026
Department of Psychosomatic Dentistry, Graduate School of Medical and Dental Sciences Institute of Science Tokyo Tokyo Japan.
Papers in Europe PMC - 04Mignogna MD10 papers · 2026
Department of Neuroscience, Reproductive and Odontostomatological Sciences, Oral Medicine Unit, University of Naples Federico II, Naples, Italy.
Papers in Europe PMC - 05Suga T9 papers · 2026
Department of Psychosomatic Dentistry, Graduate School of Medical and Dental Sciences Institute of Science Tokyo Tokyo Japan.
Papers in Europe PMC - 06Canfora F7 papers · 2026
Department of Neuroscience, Reproductive and Odontostomatological Sciences, Oral Medicine Unit, University of Naples Federico II, Naples, Italy.
Papers in Europe PMC - 07Watanabe M6 papers · 2026
Department of Psychosomatic Dentistry, Graduate School of Medical and Dental Sciences Institute of Science Tokyo Tokyo Japan.
Papers in Europe PMC - 08
- 09
- 10Li X5 papers · 2026
Department of Periodontics and Oral Mucosal Diseases, The Affiliated Stomatology Hospital of Southwest Medical University, Luzhou, China.
Papers in Europe PMC
Clinical research
Is a treatment being tested?
38
interventional trials for this specific condition
38 interventional trials matched this specific condition name; 4 currently recruiting in our sample.
Data as of 11 September 2026
38 interventional trials — more than 77.2% of diseases in the trials denominator have none at all (5501 of 7126; this disease is at the 96.6th percentile).
low confidence · 96.6th percentile (trials denominator)
Recruiting interventional trials
From the matched ClinicalTrials.gov set
38 interventional trials matched after quoted-phrase search and title/condition post-filter.
- NCT07344909·NOT YET RECRUITING·Burning Mouth Syndrome: Effects of Occlusal Splint Therapy
Not reviewed·Conditions: Burning Mouth Syndrome · Orofacial Pain · Mouth Dryness·Matched via name + MeSH
- NCT07721090·NOT YET RECRUITING·Improving Prescribing Quality for Oral Mucosal Disorders Using a Pharmacist-Led Model
Not reviewed·Conditions: Oral Lichen Planus · Recurrent Aphthous Stomatitis · Burning Mouth Syndrome · Oral Candidiasis·Matched via name + MeSH
- NCT07016555·RECRUITING·Burning Mouth Syndrome: Symptoms and Management
Not reviewed·Conditions: Burning Mouth Syndrome·Matched via name + MeSH
- NCT07506018·RECRUITING·MucoLock™ for Treatment of Stomatitis
Not reviewed·Conditions: Stomatitis · Pain · Burning Mouth · Burning Mouth Syndrome·Matched via name + MeSH
Observational and natural-history studies
8 observational studies match this condition. These do not test a treatment and are not counted in the interventional-trial headline, but they are genuine research: natural-history work often defines the endpoints needed for a future rare-disease trial, and families may be able to enroll.
Recruiting or not-yet-recruiting
- NCT05819697·RECRUITING·Reducing Patient Memory Recall in the Burning Mouth Patient Population
Not reviewed·Conditions: Burning Mouth Syndrome·Matched via name + MeSH
Other registries (secondary)
Broader net from EU CTIS, ISRCTN, and ICTRP when available — deduped against ClinicalTrials.gov IDs already counted above. Dual-model LLM relevance gates what we keep. These rows are not added to the interventional headline.
raw 11 · after dedupe 11 · already on CT.gov 0 · kept 0 · parent 0 · uncertain 11 · dropped 0 · fetched 2026-07-30
Source notes: ictrp: Error: ICTRP public search unavailable (WHO portal is SPA-only; SOAP needs partnership). Tried: https://apps.who.int/tri
No secondary-registry studies passed dual-model relevance for this condition name (after dedupe).
Uncertain / not reviewed (11)
- ctis·2023-509727-40-00·Authorised, ongoing·Burning mouth syndrome: A novel treatment
skipped — LLM skipped (--skip-llm)
- isrctn·ISRCTN12633596·No longer recruiting·A study to test mirvetuximab soravtansine in women with platinum sensitive, advanced epithelial ovarian, primary peritoneal, or fallopian tube cancers.
skipped — LLM skipped (--skip-llm)
- isrctn·ISRCTN57815030·No longer recruiting·A study to assess the distribution of entrectinib capsule in the blood of healthy adults compared to nasogastric and oral suspension of entrectinib
skipped — LLM skipped (--skip-llm)
- isrctn·ISRCTN13795228·No longer recruiting·Vortioxetine versus other antidepressants in the treatment of Burning Mouth Syndrome
skipped — LLM skipped (--skip-llm)
- isrctn·ISRCTN97009661·No longer recruiting·Cannabis Sativa oil for the treatment of burning mouth syndrome
skipped — LLM skipped (--skip-llm)
- isrctn·ISRCTN15143752·No longer recruiting·Analysis of the effects of GERDOFF tablets in patients with gastric reflux who do not respond to other drugs (alginates)
skipped — LLM skipped (--skip-llm)
- isrctn·ISRCTN71177327·No longer recruiting·AS Orthana® versus Biotène Oralbalance® for patients with dry mouth
skipped — LLM skipped (--skip-llm)
- isrctn·ISRCTN05731670·No longer recruiting·Syalogram in chronic fatigue syndrome
skipped — LLM skipped (--skip-llm)
- isrctn·ISRCTN40332511·Stopped·A pilot study to evaluate the use of pregabalin in the management of burning mouth syndrome
skipped — LLM skipped (--skip-llm)
- isrctn·ISRCTN25268811·Stopped·Randomised double blind placebo controlled trial of calcium supplements in teenage pregnancy
skipped — LLM skipped (--skip-llm)
- isrctn·ISRCTN77911445·No longer recruiting·The study is to test the safety and tolerability of a drug called JNJ-39439335, also known as Mavatrep which is being developed for the treatment of pain from osteoarthritis
skipped — LLM skipped (--skip-llm)
Where to find support
Condition-specific patient organisations, when Orphanet lists them, are on the disease’s Orphanet page. We also link umbrella groups that support undiagnosed and ultra-rare families.
Orphanet entry for Burning mouth syndrome — check Associations / patient organisations on that page.
India — NPRD
Last verified 2026-07-26This ORPHAcode is not on our curated NPRD list (direct or Mondo-parent match). That does not decide clinical eligibility; families in India should ask a notified Centre of Excellence about current coverage.
Hand-curated for this project. ORPHAcode mappings are best-effort and may be incomplete or imprecise for umbrella categories. Parent (Mondo) matches mean the policy lists a broader category — confirm eligibility with a Centre of Excellence. Financial entitlements summarised from public policy statements and may change. This is not official government guidance.
How we counted this
Europe PMC query (preferred label + any corrected label + Orphanet and Mondo exact synonyms, stoplisted; unioned with resolved MeSH labels when available). UMLS / OMIM / NCIT cross-references are stored on the overview but are not added to the query string.
"Burning mouth syndrome" OR "Oral dysesthesia" OR "Orodynia" OR "Stomatodynia" OR "Stomatopyrosis"
MeSH descriptor terms unioned into the query: Burning Mouth Syndrome
ClinicalTrials.gov query (quoted phrases + MeSH via query.cond, plus recall-expansion terms when used):
"Burning mouth syndrome" OR "Oral dysesthesia" OR "Orodynia" OR "Stomatodynia" OR "Stomatopyrosis"
Interventional trials matched via: both (mesh = registered under a MeSH descriptor no name phrase would catch; recall-expansion = gene / selected parent terms used only for trials).
Study-type breakdown: 38 interventional · 8 observational · 0 expanded access. Only interventional studies enter the trial headline.
Query health: ok — strategies attempted: phrase, mesh; with hits: phrase, mesh
Run this search on ClinicalTrials.gov
Synonyms dropped by stoplist: BMS
Confidence reasoning
- Preferred label is multi-word and distinctive
- 1 synonym(s) dropped by stoplist (may under-count)
- No label/synonym collisions with other diseases in this corpus
- Publication count (3497) is extremely high with unknown/missing prevalence — treat as possible over-matching, not proven research intensity
Ingested 2026-07-27T14:24:29.116Z
