Table 6 Treatments for OSMF

Antioxidant treatments

Lycopene

Karemore T. V. and Motwani M [55].

Single blinded prospective study

92

Ingestion of 8 g/QD of lycopene (n = 46) for three months was shown to be effective in the reduction of burning mouth and mouth opening (p < 0.05) in patients with OSMF when compared to the placebo group (n = 46).

Curcumin

Hazarey V. et al. [56]

Randomized control clinical trial

30

Sucking 2 g/QD of Curcumin lozenges (n = 15) with physiotherapy for three months showed a significant improvement in both mouth opening and in alleviating the burning sensation (p < 0.05) in comparison to the control group (clobetasol propionate 0.05%; (n = 15).

Micronutrient therapy

Maher R. et al. [57]

Single arm preliminary prospective study

117

Swallowing micronutrient supplements: vitamins A, B complex, C, D, E; and minerals iron, calcium, copper, zinc, and magnesium was observed to be significantly effective (p < 0.05) in reduction of sign and symptoms of OSMF over 3 years.

Spirulina and Aloe Vera

Patil S. et al. [58]

Double blinded prospective study

42

Ingestion of 500 mg/QD of Spirulina (n = 21) for 3 months was associated with a significant improvement in mouth opening and reduction in ulcers/erosions/vesicles (p < 0.05) in comparison to 5 mg of aloe vera (n = 21) for the same time. Improvement in burning sensation and pain associated with lesions was not found significant between two groups

Alam S. et al. [59]

Double-blinded, placebo- controlled, parallel-group randomized controlled trial

60

Application of aloe vera gel over buccal mucosa, palate, retromolar region, and floor of the mouth twice daily during submucosal injection of hyaluronidase and dexamethasone (n = 15) and surgical treatment (buccal fat pad, nasolabial flap, or collagen membrane, (n = 15) treatment with 6 months of follow up was observed to be a significant adjuvant therapy in reduction of most of the symptoms of OSMF (p < 0.01), in comparison to a similar group of medicines alone, (n = 15) and surgical procedures (n = 15)] with no application of aloe vera.

Medicinal treatments

Steroids

Goel S. et al. [60]

Longitudinal prospective study

270

4 mg/ml/biweekly injections of Betamethasone diluted in 1.0 ml of 2% xylocaine for 6 months given on buccal mucosa, bilaterally, using an insulin syringe, with a half dose on each side, was showed significant improvement of mouth opening and reduction in burning sensation in a stage II and stage III OSMF group (p < 0.0001), in comparison to a control group which received no treatment over two years.

Hyaluronidase

James L. et al. [61]

Retrospective study

28

Intralesional injection of Hyaluronidase 1500 IU mixed in 1.5 ml of dexamethasone and 0.5 ml of lignocaine hydrochloride biweekly for 4 weeks showed a significant improvement in mouth opening with net gain of 6 ± 2 mm (92%), reducing the burning sensation (89%), number of painful ulceration (78%) and blanching of oral mucosa (71%) for Grade III OSMF patients.

Colchicine + Hyaluronidase

Krishnamoorthy B. & Khan M [62].

Comparative prospective study

50

1 mg/ day colchicine tablet and 0.5 ml intralesional Injection hyaluronidase 1500 IU/ once a week (group I, n = 25) for twelve weeks showed a significant improvement in mouth opening (p < 0.05) and reduced burning sensation (33% by second week) in comparison to subjects treated with 0.5 ml intralesional injection of hyaluronidase 1500 IU and 0.5 ml intralesional injection hydrocortisone acetate 25 mg/ml once a week alternatively (group II, n = 25).

Placental extracts

Singh P. et al. [63]

Comparative prospective study

10

2 ml intralesional placental extract mixed with 2 ml of 2% lignocaine HCL weekly for an interval of 8 weeks showed an average improvement in mouth opening by 8.02 mm (average pretreatment mouth opening = 18.49 mm, average posttreatment mouth opening = 26.51 mm) with average marked reduction in burning sensation by 4.9 (average pretreatment burning sensation = 8.0, average posttreatment burning sensation = 3.1). Burning sensation was assessed using visual analogue scale with 0–10, where 0 = no burning sensation and 10 = maximum burning sensation.

Isoxupurine

Bhadage C. J. et al. [64]

Prospective study

40

10 mg Isoxsuprine tablets/ QID with oral physiotherapy (Group A, n = 15) plus 2 ml dexamethasone by intralesional injection with 1500 IU hyaluronidase mixed with 1 ml of 2% lignocaine solution with adrenaline 1:80,000 (Group B, n = 15) for six weeks with a follow up of 4 months, showed a significant improvement in mouth opening (p < 0.05) and burning sensation (p < 0.00001) in comparison to the placebo group (only oral physiotherapy) (Group C, n = 10).

Pentoxifylline

Rajendran R. et al. [65]

Randomized controlled clinical trial

29

400 mg/ TID of Pentoxifylline tablets (n = 14) for seven months showed a significant improvement in mouth opening (p < 0.0001), tongue protrusion (p < 0.05), relief from perioral fibrotic bands (p < 0.0001), subjective symptoms of intolerance to spices (p < 0.0001), burning sensation of mouth (p < 0.0001), tinnitus (p < 0.0001), difficulty in swallowing (p < 0.0001) and difficulty in speech (p < 0.0001) in comparison to the control group (multivitamin with local heat therapy, n = 15).

Oral physiotherapy

Ultrasound + Physiotherapy

Kumar V. et al. [66]

Single arm prospective study

15

Ultrasound therapy with 0.7–1.5 W/Cm² with thumb kneading physiotherapy for six days/ week for two consecutive weeks showed significant improvement in mouth opening (p < 0.001) and reduction of burning sensation.

Surgical approaches

Surgery

Kamath V. V [67].

Systematic Review

–

Lasers, tongue flap, palatal flap, buccal fat pad, nasolabial flap, thigh flaps, split skin grafts, collagen membrane, artificial dermis, human placenta grafts, coronoidectomies, muscle myotomies and oral stents. All surgeries have shown significant improvement in the symptoms of OSMF. However there exist no definite protocols and thus author comments that treatment remains subjective to the operating surgeon.