Effectiveness of Fenugreek as an Adjuvant in the Management of Oral Potentially Malignant Disorders: A Randomized Controlled Trial.
- 2025-01-13
- The journal of contemporary dental practice 25(10)
- Nandhini Balasundaram
- Mb Aswath Narayanan
- Leena Selvamary Arul Antony
- Sg Ramesh Kumar
- Sujatha Anandan
- PubMed: 39873252
- DOI: 10.5005/jp-journals-10024-3773
Study Design
- Type
- Randomized Controlled Trial (RCT)
- Sample size
- n = 11
- Population
- 21 participants prediagnosed with OPMDs (leukoplakia, lichen planus, oral submucous fibrosis)
- Methods
- Randomized, 2 gm fenugreek as adjuvant with standard systemic treatments tailored to respective lesions vs standard treatment only; data collected and analyzed using SPSS
- Duration
- 2 months
- Funding
- Unclear
Aim
This study aimed to evaluate the effectiveness of fenugreek as an adjuvant in managing oral potentially malignant disorders (OPMDs), specifically leukoplakia, lichen planus, and oral submucous fibrosis (OSMF).Materials and methods
Twenty-one participants prediagnosed with OPMDs were randomly divided into a study group (SG) and a control group (CG), with 10 participants in SG and 11 in CG, respectively. The SG received 2 gm of fenugreek as an adjuvant with standard systemic treatments tailored to the respective lesions: intralesional injection of vitamin A 1,00,000 IU (Aquasol A) and topical application of triamcinolone acetonide 0.1% (Kenacort) for 2 months for leukoplakia. Subjects with oral lichen planus were administered prednisolone 5 mg/day (Wysolone), chlorhexidine mouthwash 0.2% (Peridex), and Zincovit once daily for 8 weeks. For subjects with OSMF, one capsule of SM Fibro once daily for 12 weeks along with dexamethasone 1.5 mL (Decadron) was given, and hyaluronidase 1,500 IU (Hynidase) with 0.5 mL lignocaine HCL (Xylocaine) was injected intralesionally biweekly and mouth exercise was advised for 2 months; control group received only the standard treatment. Sociodemographic data were collected, and clinical assessments, evaluating size and shape for leukoplakia, erythema, and burning sensation for oral lichen planus, and mouth opening, cheek flexibility, and burning sensation for OSMF were assessed from baseline through 2 months. Data collected were organized in Excel and analyzed using Statistical Package for the Social Sciences version 21.0.Results
The SG and CG had 10 and 11 participants, with 4 in each group for leukoplakia, 2 participants in SG and 3 in CG for lichen planus, and 4 participants for OSMF in each group, respectively. Most participants presented with leukoplakia under 2 cm on the buccal mucosa bilaterally, with no significant changes in size or shape postintervention. For lichen planus, mild erythema and burning sensation were noted, but there were no significant differences within or between groups postintervention. A mild burning sensation, a statistically significant improvement in mouth opening was observed in SG (p < 0.051) when compared with CG after 8 weeks postintervention in OSMF. Also, significant improvement in cheek flexibility was noted from baseline to the fourth follow-up in SG post intervention. However, there were no differences between groups during the follow-up period.Conclusion
The findings from this trial suggest that SG showed significant improvement in OSMF than CG, whereas the improvements in leukoplakia and lichen planus remained same in both groups.Clinical significance
Fenugreek, being a cost-effective and affordable agent known for its anticancer, anti-inflammatory, antioxidant, and antiulcerative properties, could be used as an adjuvant for its management in OPMDs. How to cite this article: Balasundaram N, Narayanan MBA, Arul Antony LS, et al. Effectiveness of Fenugreek as an Adjuvant in the Management of Oral Potentially Malignant Disorders: A Randomized Controlled Trial. J Contemp Dent Pract 2024;25(10):921-929.Research Insights
significant improvement in cheek flexibility was noted from baseline to the fourth follow-up in SG post intervention.
- Effect
- Beneficial
- Effect size
- Small
- Dose
- 2 gm
a statistically significant improvement in mouth opening was observed in SG (p < 0.051) when compared with CG after 8 weeks postintervention in OSMF.
- Effect
- Beneficial
- Effect size
- Moderate
- Dose
- 2 gm
For lichen planus, mild erythema and burning sensation were noted, but there were no significant differences within or between groups postintervention.
- Effect
- Neutral
- Effect size
- Small
- Dose
- 2 gm
For lichen planus, mild erythema and burning sensation were noted, but there were no significant differences within or between groups postintervention.
- Effect
- Neutral
- Effect size
- Small
- Dose
- 2 gm
Most participants presented with leukoplakia under 2 cm on the buccal mucosa bilaterally, with no significant changes in size or shape postintervention.
- Effect
- Neutral
- Effect size
- Small
- Dose
- 2 gm