|Year : 2019 | Volume
| Issue : 4 | Page : 328-332
Comparative efficacy of intralesional placental extract and intralesional triamcinolone acetonide in the management of OSMF
Christopher V Shinde1, Nisheeth Saawarn2, Sahil Kohli3, Pooja Khare1, Ajita Singh1, Krishna M Sagar4
1 Department of Oral Medicine and Radiology, People's Dental Academy, Bhopal, Madhya Pradesh, India
2 Department of Oral Medicine and Radiology, Bhabha College of Dental Sciences, Bhopal, Madhya Pradesh, India
3 Department of Oral Medicine and Radiology, RKDF Dental College and Research Centre, Bhopal, Madhya Pradesh, India
4 Department of Pediatric and Preventive Dentistry, People's Dental Academy, Bhopal, Madhya Pradesh, India
|Date of Submission||20-Aug-2019|
|Date of Acceptance||01-Jan-2020|
|Date of Web Publication||03-Mar-2020|
Dr. Christopher V Shinde
Department of Oral Medicine and Radiology, People's Dental Academy, People's University, Bhopal, Madhya Pradesh
Source of Support: None, Conflict of Interest: None
| Abstract|| |
Context: Oral submucous fibrosis (OSMF) is characterized by excessive collagen production in the submucosa leading to progressive fibrosis of the oral mucosa and atrophic changes of the epithelium. Aim: To clinically evaluate the efficacy of intralesional injections of placental extract (2ml) in comparison to intralesional injections of triamcinolone acetonide (40mg/ml; 1ml) in the management of OSMF patients. Methodology: This randomized, parallel-group, single-blinded outcome-based study, consisted of 40 diagnosed cases of OSMF. The patients were divided into two groups of 20 each in placental extract group and triamcinolone acetonide group. Patients were administered test medications weekly in respective groups by intralesional mode for a period of 10 weeks. Parameters taken into consideration and compared weekly were burning sensation, pain, mouth opening, tongue protrusion, and cheek flexibility. Result: The data so obtained was tabulated and subjected to statistical analysis using Chi-square test, Mann–Whitney test, Wilcoxon ranked test, and t-test by means of SPSS version 20 software to reach conclusive results. There was significant improvement in burning sensation, pain, mouth opening, tongue protrusion, and cheek flexibility in both groups. Better and faster improvement in tongue protrusion and cheek flexibility was achieved in triamcinolone group as against placental extract group. Conclusion: The intralesional triamcinolone acetonide was found to be a superior intralesional drug in comparison to placental extract.
Keywords: Burning sensation, cheek flexibility, mouth opening, oral submucous fibrosis, placental extract, tongue protrusion, triamcinolone acetonide
|How to cite this article:|
Shinde CV, Saawarn N, Kohli S, Khare P, Singh A, Sagar KM. Comparative efficacy of intralesional placental extract and intralesional triamcinolone acetonide in the management of OSMF. J Indian Acad Oral Med Radiol 2019;31:328-32
|How to cite this URL:|
Shinde CV, Saawarn N, Kohli S, Khare P, Singh A, Sagar KM. Comparative efficacy of intralesional placental extract and intralesional triamcinolone acetonide in the management of OSMF. J Indian Acad Oral Med Radiol [serial online] 2019 [cited 2020 Apr 4];31:328-32. Available from: http://www.jiaomr.in/text.asp?2019/31/4/328/279854
| Introduction|| |
Oral submucous fibrosis (OSMF), known since ancient times and termed “Vidhari” in Indian medical literature by Sushruta, a renowned Indian physician (600 B.C), was first described in the modern literature by Schwartz in 1952.
It affects about 0.2%–0.5% population of Indian population in the age group of 11 to 60 years with a slight male predilection. Malignant transformation rate is reported to be 7.6% with median 10 years follow-up period.
Although placental extract and triamcinolone acetonide have been used individually in various studies with varying success rates,,,, there are very few studies, comparing the efficacy of both these drugs. Thus, this study was designed to evaluate the comparative efficacy of the intralesional placental extract with that of intralesional triamcinolone acetonide in the treatment of OSMF.
| Material and Methods|| |
This prospective randomized single-blinded outcome-based study, designed in accordance with Helsinki's guidelines, was conducted in the Oral Medicine and Radiology Department of a dental school in India between March 2014 till April 2015, after obtaining ethical clearance from the institutional ethical committee. Forty clinically diagnosed cases of OSMF of either sex, falling under grade 2 and grade 3 severity as per Kerr et al., who did not have any coexisting disease or disorder of orofacial region or systemic illness which may interfere with study protocol and who have not undergone any treatment for OSMF in past, were enrolled in the study after obtaining a written informed consent.
The study subjects consented to quit the gutka, arecanut and/or tobacco chewing habit and attend regular follow-ups. A strict tobacco cessation protocol was followed pursuing the guidelines and framework of 5A intervention method (Ask, Advice, Assess, Assist and Arrange). A routine blood test was performed prior to commencement of the study and patients within normal range were only selected. Patients under grade 4 and 5 (Kerr et al.) were not included as they did not satisfy the inclusion criteria of the study. The subjects in Grade 1 were also not included because their symptoms were very mild and mouth opening was close to normal and adequate. The study subjects were randomly allocated through a coin toss or lottery method to one of the two groups, viz. Group-P or Group-T and administered intralesional injections of aqueous placental extract (placental extract 2ml.) or triamcinolone acetonide (40mg/ml; 1ml), respectively, into the right and left buccal mucosa by single-needle penetration method at weekly intervals continuously for 10 weeks. The criteria assessed at first and every follow-up visit were burning sensation and pain on VAS, interincisal mouth opening, cheek flexibility, and tongue protrusion. The data so obtained was tabulated and subjected to statistical analysis using Chi-square test, Mann–Whitney test, Wilcoxon ranked test, and t-test by means of SPSS version 20 software to reach conclusive results. Comparison of overall treatment response was done as per the Tel Aviv–San Francisco Scale. After completion of study, a yearlong follow-up was done with thorough oral examination to access overall oral health and criteria measured to reassure that the patients comply with the strict protocol of the study and to measure if any deterioration in the condition. There was no deterioration in any case successfully completed in our study.
| Results|| |
The study group comprised of 32 males and 08 females in the age group of 17 to 59 years [Table 1]. Gutka with tobacco was the most common habit followed by tobacco with lime and the buccal vestibule was the most common site for the quid placement [Figure 1] and [Figure 2].
|Figure 2: Distribution of sites involved in each patient. B- buccal,T- Tongue, L- labial, FOM- floor of mouth, PTR- pterygomandibular raphe, U-uvula, SP- soft palate P- pharynx|
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There was a significant reduction in burning sensation in both the groups from 2nd week onwards; however, there was no significant difference between Group-P and Group-T upon intergroup comparison at the end of the treatment [Table 2], [Table 3], [Table 4]. The pain reduced in both the groups and was found to be significant on 1st and 2nd follow-up visits, respectively; however, upon comparison, there was no significant difference between Group-P and Group-T [Table 2], [Table 3], [Table 4].
Like pain and burning sensation, the mouth opening too gradually increased significantly from 1st follow-up onwards in both the groups. However, no statistically significant difference was noted between both the groups at the end of the treatment [Table 2], [Table 3] [Table 4].
Like other symptoms, the tongue protrusion and cheek flexibility too improved gradually; better and faster improvement was achieved in Group-T compared to Group-P for both these criteria [Table 2], [Table 3] [Table 4].
Further analysis of treatment response revealed that no significant difference was noted in between patients of grade 2 and grade 3 OSMF in either of the groups for any of the criteria [Table 5], [Table 6], [Table 7].
On comparing the overall treatment response as per the Tel Aviv–San Francisco Scale, in Group-P, 14 (70%) patients showed 50% or more benefit and 07 (35%) patients showed 70%–100% relief with no requirement of further treatment. While in the Group-T, 16 (80%) patients showed 50% or more benefit and 08 (40%) patients showed 70%–100% relief. Three patients in Group-P and two patients in Group-T showed little or no improvement, but none of the patients in either group showed any deterioration [Table 8].
|Table 8: Comparison of overall treatment response as per the Tel Aviv-San Francisco Scale|
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If stages 3 and 4 are taken together as cured and stage 2 or lesser as partially cured/uncured, then at the end of the treatment, 07 (35%) patients in Group-P and 08 (40%) in Group-T were cured and 13 (65%) in Group-P and 12 (60%) in Group-T remained partially cured or uncured[Table 8].
Upon further modifying the criteria and taking stages 2, 3, and 4 together as partially/completely cured and 1, 0, and −1 as uncured, 14 (70%) patients in Group-P and 16 (80%) in Group-T were partially/completely cured [Table 8].
| Discussion|| |
OSMF is a chronic, insidious disease that is associated with significant functional morbidity and an increased risk for malignancy. It has a multifactorial etiology with several factors such as areca nut chewing, genetic susceptibility, autoimmunity, collagen disorders and nutritional deficiency states have been suggested to be involved in the pathogenesis.
A rapid increase in the disease has been noted, which may be attributed to an upsurge in the popularity of commercially prepared areca nut preparations (pan masala) and an increased uptake of this habit by young people due to easy access, effective pricing, and aggressive marketing strategies.
Among the areca alkaloids, viz, arecoline, arecadine, guvacoline, and guvacine, arecoline is the main agent responsible for fibroblast proliferation and elevated collagen synthesis by fibroblasts. Areca flavonoids, tannins and catechins, inhibit collagenase enzyme activity and cause increased fibrosis by promoting more stable and nonsoluble collagen structure. The supra-added lime and the chemicals in the pan masala increase the permeability of oral mucosa, leading to easy access of submucosal tissue to the areca alkaloids and flavonoids and a rapid onset of the disease. Thus, OSMF is primarily a disease of dysregulation in collagen metabolism.
Clinical features of OSMF are primarily debilitating and adversely affect the quality of life. It initiates with blanching and progressive fibrosis of oral mucosa, burning sensation on taking spicy food, mucosal atrophy, dryness of the mouth, defective gustatory sensation, progressive restriction of mouth opening, and protrusion of the tongue, difficulty in swallowing.,
Till date, there has been no universally accepted cure reported in the scientific literature for the disease process. There is an enormous listing of medications in the literature worldwide and large intralesional injections are primary mode of treatment due to their ability to deposit the medicament topically for longer action better, bioavailability, and better compliance with least adverse effects. Topical steroids like triamcinolone acetonide and biogenic amines like placental extract have been reported to be useful with varying success rates by various authors.,,,
In the present study in both triamcinolone and placental extract group, there was significant improvement in all criteria evaluated for the disease condition. However, there was no significant difference in treatment response when compared on the basis of disease severity.
A clinical study done with intralesional placental extract by Vaidya and Sharma recorded highest improvement in burning sensation by 77% while mouth opening by 29%, whereas study done with intralesional triamcinolone acetonide by Singh et al. recorded highest increase in the mouth opening and tongue protrusion by 57% and 54%, respectively.
Studies with intralesional triamcinolone by Gupta et al. with improvement in mouth opening by 20% and reduction in burning sensation by 57% and Katharia et al. with improvement in mouth opening and burning sensation by 28% and 40%, respectively, and improvement in tongue protrusion by 18% were found to be almost equivalent to studies done with placental extract, namely, by Samuel and Renukananda with increase in mouth opening by 20% and reduction in burning sensation by 40% and Ameer and Shukla with increase in mouth opening by 28%.
By and large the comparison of results of various studies concluded intralesional triamcinolone to be a superior drug in terms of improvement in mouth opening and tongue protrusion while placental extract was better with relieving burning sensation. However, rest all other studies demonstrated almost or near equivalent treatment response.
In our study too, there was no significant difference between the two groups when compared on the basis of mouth opening, burning sensation, and pain. Although both the groups showed improvement in tongue protrusion and cheek flexibility, triamcinolone group showed better response in tongue protrusion as the improvement was significant from 5th week onwards, which was not in the case of placental extract group. Better and faster improvement in cheek flexibility was achieved in triamcinolone group as against placental extract group.
The therapeutic potential of steroids lies in the suppression of the underlying inflammation, autoimmune response, and hypersensitivity. Steroids also inhibit the proliferation of fibroblasts and thus cause a reduction in the number of collagen fibers. Thus, steroids have proved to be superior intralesional drug with excellent properties of antiinflammatory, immunosuppressive, and antiallergic agent.
Aqueous extract of human placenta contains nucleotides, enzymes, vitamins, amino acids, and steroids. Its action is essentially “biogenic stimulation.” Its use is based on the “tissue therapy” method. It accelerates cellular metabolism, has antiinflammatory and immunostimulating properties, aids in absorption of exudates by controlling its formation, and stimulates tissue regeneration processes. Thus, the injectable form of placental extract is found to be very effective, less expensive, and has excellent healing, regenerative, and antiinflammatory properties suitable for treatment in OSMF.
In our study, the intralesional triamcinolone acetonide was found to be a superior intralesional drug in comparison to placental extract in many aspects for the treatment of this condition. The findings of the present study were in agreement with a similar study done by Naik et al. and Sikdar et al. However, steroids, even in topical form, come with their riders. Despite their clinical efficacy, they can induce multiple adverse effects. Thus, the research, including the present one, continues to explore an equivalent or better but safer substitute for steroids. Hence, placental extract can be used to replace it as it has similar efficacy.
Declaration of patient consent
The authors certify that they have obtained all appropriate patient consent forms. In the form, the patients have given their consent for their images and other clinical information to be reported in the journal. The patients understand that their names and initials will not be published and due efforts will be made to conceal their identity, but anonymity cannot be guaranteed.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2]
[Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6], [Table 7], [Table 8]