Oral submucous fibrosis

Summary

Oral submucous fibrosis (MONDO:0018166) is a disease and 14 clinical trials. Top therapeutic interventions include betamethasone dipropionate, betamethasone valerate, and hyaluronic acid. A subtype of mouth disorder — broader associated-gene and molecular evidence is on the parent page (see Disease family below).

At a glance

• Prevalence: Unknown (Worldwide)
• Phenotypes (HPO): 7
• Clinical trials: 14

Clinical features

Signs & symptoms

Clinical features (HPO)

7 HPO clinical features (Orphanet curated; top 7 by frequency):

HPO ID	Term	Frequency
HP:0000160	Narrow mouth	Very frequent (80-99%)
HP:0000163	Abnormal oral cavity morphology	Very frequent (80-99%)
HP:0000600	Abnormality of the pharynx	Very frequent (80-99%)
HP:0100825	Cheilitis	Very frequent (80-99%)
HP:0000211	Trismus	Frequent (30-79%)
HP:0001371	Flexion contracture	Frequent (30-79%)
HP:0012182	Oropharyngeal squamous cell carcinoma	Occasional (5-29%)

Identifiers

Disease identifiers

Field	Value
Canonical name	oral submucous fibrosis
Mondo ID	MONDO:0018166
EFO	EFO:1001818
MeSH	D009914
Orphanet	357154
DOID	DOID:5773
ICD-10-CM	K13.5
ICD-11	1798376929
NCIT	C34866
SNOMED CT	32883009
UMLS	C0029172
MedGen	45213
GARD	0007264
Is cancer (heuristic)	no

Also known as: oral cavity submucous fibrosis · oral submucosal fibrosis, including of tongue · OSMF

Disease family

This is a subtype of mouth disorder. Genetic, therapeutic, and trial evidence is largely curated at the broader-term level — see the parent page for the associated-gene cohort and molecular evidence.

Classification path: disease › human disease › disease by body system or component › mouth disorder › oral submucous fibrosis

Related subtypes (26): uvulitis, adenoid hypertrophy, oral hairy leukoplakia, salivary gland disorder, tongue disorder, alveolar periostitis, lip disorder, oral Crohn disease, maxillary sinusitis, oral candidiasis, oral tuberculosis, Ludwig’s angina, maxillary sinus cholesteatoma, burning mouth syndrome, oral leukoedema, tooth disorder, commissural lip fistula, florid cemento-osseous dysplasia, oral cavity neoplasm, neoplasm of floor of mouth, polyp of maxillary sinus, neoplasm of jaw, osteoradionecrosis of the mandible, odontoma, lichen planus, oral, mouth mucosa disorder

Genetics & variants

GWAS landscape

No GWAS associations recorded — common-variant (GWAS) studies don’t cover this disease (typical for Mendelian / rare diseases). See the curated gene cohort and Mendelian overlap below.

Variant details and genetic-evidence tiers

No tiered GWAS variants or ClinVar records for this disease.

Genes & proteins

No associated-gene cohort resolved for this disease. Atlas builds the molecular and therapeutic sections — associated genes, protein families, druggability, pathways, interactions, and drug associations — by aggregating over a disease’s associated genes (resolved via GWAS / GenCC / ClinVar / CIViC), and none resolved here. This is expected for antibody-mediated, autoimmune, or otherwise non-gene-defined conditions; the curated evidence for this disease is its clinical features, GWAS susceptibility, and clinical trials (above).

Function

No pathway enrichment — requires an associated-gene cohort.

Therapeutics

Drugs indicated for this disease

0 approved, 3 in late-stage (phase 3) trials. Disease-direct ChEMBL indications, not inferred from the associated-gene cohort below.

Drug	Development status
Betamethasone Valerate	Phase 3 (in late-stage trials)
Hyaluronic Acid	Phase 3 (in late-stage trials)
Hydrocortisone	Phase 3 (in late-stage trials)

Earlier-phase candidates (phase 2, investigational — efficacy not yet established): Curcumin.

Clinical trials & evidence

Clinical trials

Clinical trials: 14.

Phase distribution (across all retrieved trials)

Phase	Trials
Not specified	7
PHASE3	3
PHASE2	2
PHASE1/PHASE2	2

Top trials by phase / activity

NCT	Phase	Status	Title
NCT06758739	PHASE3	NOT_YET_RECRUITING	Comparison of Curcumin and Intralesional Steroids in Oral Submucous Fibrosis
NCT02714543	PHASE3	COMPLETED	Evaluation of Efficacy of Aloevera in the Treatment of Oral Submucous Fibrosis- A Clinical Study
NCT04476420	PHASE3	COMPLETED	Comparative Effect of Nigella Sativa and Conventional Management for OSMF
NCT02645656	PHASE2	UNKNOWN	Topical Application of Curcumin Orabase in Oral Submucous Fibrosis (OSMF)
NCT03511261	PHASE2	UNKNOWN	Efficacy of Curcumin in Oral Submucous Fibrosis
NCT06332612	PHASE1/PHASE2	COMPLETED	Metformin Repurposing in Oral Submucous Fibrosis: Unveiling In Vitro Signaling Pathways, Progressing to Clinical Trial
NCT06871904	PHASE1/PHASE2	COMPLETED	Fibrosis-Modulating Effects of Metformin and Pirfenidone in Oral Submucous Fibrosis
NCT06639009	Not specified	RECRUITING	Effect of Laser Photobiomodulation in Improving Mouth Opening in Oral Submucous Fibrosis
NCT07277998	Not specified	NOT_YET_RECRUITING	Alternating Triamcinolone and Platelet-Rich Plasma Therapy for Oral Submucous Fibrosis
NCT02711046	Not specified	COMPLETED	Use of Single Staged Nasolabial Flap in Oral Submucous Fibrosis
NCT03011086	Not specified	COMPLETED	Evaluation of Auto Antibodies in Oral Sub Mucous Fibrosis
NCT03732872	Not specified	COMPLETED	Epithelial Mesenchymal Transition Markers in OSMF
NCT04153266	Not specified	COMPLETED	Oral Epithelial Dysplasia Informational Needs Questionnaire
NCT04487938	Not specified	UNKNOWN	Oral Cancer Screening and Education in Hong Kong

Drugs tested across these trials (top 30)

Molecule	Max phase	Trials referencing
BETAMETHASONE DIPROPIONATE	4	1
BETAMETHASONE VALERATE	4	1
HYALURONIC ACID	4	1
HYDROCORTISONE	4	1
METFORMIN	4	1
PENTOXIFYLLINE	4	1
PIRFENIDONE	4	1
VITAMIN E	4	1
CURCUMIN	3	2