Open Access

Table I

Eligibility criteria of included studies according to Participants, Intervention, Comparator and Outcomes (PICO).

INCLUSION EXCLUSION
● Participants (P):
○ Patients clinically and/ 0r histopathologically diagnosed with Oral Submucous Fibrosis.
○ No history of prior treatment for the same or have discontinued treatment since one to two weeks.
● Intervention (I): Spirulina used in any form (topical / intralesional / systemic).
● Comparator(C): Placebo or Any other medicinal treatment or any other treatment modality.
● Outcomes (O):
Main outcomes-
○ Maximum mouth opening measured from the incisal edges of maxillary central incisor to mandibular central incisor using the Vernier caliper or any other method of measurement.
○ Reduction in burning sensation and pain measured using Visual analogue Scale (VAS) or any other appropriate standard method.
Additional outcomes-
○ Cheek flexibility.
○ Uvula and tongue movements.
○ Reduction in ulcers/ erosions/ vesicles.
● Study design (S): Clinical trials (Randomized and non- Randomized).
● Patients with systemic disease.
● Patients with restricted mouth opening due to other reason (pericoronitis, space infection, abscess, fractures).
● Pregnant and lactating mother.
● Presence of other potentially malignant lesions like leukoplakia, oral lichen planus etc.
● History of hypersensitivity reaction to spirulina.
● Study design(S): Case reports, case series, clinical trials without comparator/control group, Review studies, review paper, editorials letters to the editor & monographs

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