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临床试验/NCT05052775
NCT05052775已完成不适用

EFFICACY OF MORUS ALBA FRUIT EXTRACTS AND CHLORHEXIDINE ON SALIVARY STREPTOCOCCUS MUTANS AND pH LEVELS

Ziauddin University2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2020年10月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
2
主要终点
count of bacteria (streptococcus mutans)will be decrease

研究概览

简要总结

Dental caries is highly prevalent across the globe including Pakistan and is associated with tooth loss, malocclusion and temporomandibular joint problems and sometimes may cause life threatening infections. Streptococcus mutans is considered to be one of the major pathogen responsible for the development of dental caries. As treatment of dental carries is quite expensive, main focus is on the prevention of dental carries. Chlorhexidine is the gold standard mouthwash used for the prevention of dental carries but its use has been associated with certain side effects including staining of teeth, burning sensation and a bitter taste in the oral cavity. Many populations use medicinal plants as traditional or alternative treatments for various ailments due to their better safety profiles, health beneficial effects, lower cost and easy availability. Among the plant species used for medicinal purposes are those of the genus Morus. Its most commonly used species are Morus alba, rubra and nigra that have also shown antimicrobial properties against various infections in addition to other health promoting effects. Moreover, morus alba fruit has not been evaluated for its antimicrobial activity against oral pathogens including streptococcus mutans. The purpose of this study is to evaluate the antimicrobial properties against salivary streptococcus mutans and alteration of pH in the saliva of patients with dental caries before and after the use of chlorhexidine and morus alba fruit extract mouthwashes.

This study is double blinded randomised clinical trial. Sample size is calculated according to open Epi calculator and came out as 1 in each group. We will take sample size as 120 and the sampling technique will be non-probability consecutive sampling. Morus alba extract preparation will be done in the Botany department of Lasbella University of Agriculture, Water and Marine Sciences (LUAWMS) Balochistan. According to inclusion criteria and after obtaining informed consents, samples of saliva of the individuals of 18-40 year of both genders will be collected from the OPD of Dentistry department, Civil hospital Uthal Balochistan at the beginning of the study and two weeks after the treatments. The total 120 subjects will be equally divided into three groups, 40 participants in each group (A, B and C). The subjects in group A will be given chlorhexidine mouthwash and the subjects in group B and C will be given 20% and 30% aqueous extracts of morus alba fruit in the form of mouthwashes respectively. The samples of saliva will be analysed for S.mutans counts and pH levels at baseline and 15 days after the use of respective mouthwash. Culture procedure for S.mutans count will be Dilution and Spread plate technique.

详细描述

INTRODUCTION Streptococcus mutans is the major pathogen involved in the development of dental caries. This is an anaerobic gram positive coccus, naturally present in the oral microbiota and can easily colonize on the tooth surface and initiates production of acid by combining extracellular polysaccharide that results in demineralization of tooth and development of dental caries (Shah et al., 2018). The quantity of colonized surfaces is associated with streptococcus mutans in the saliva. Thus, by decreasing the concentration of Streptococcus mutans in the mouth cavity would have a significant advantage in reducing the occurrence of cariogenic microbes. (Lemos et al., 2019, Forssten et al., 2010, Banas and Drake., 2018) Dental caries is a microbial disease of the oral cavity, which is identified by demineralization of the inorganic substances and dissolution of the organic substances of the teeth. Dental caries has been recognized throughout history and exists around the world, reported to be 44%, but the severity and prevalence changes in different countries (J.V Soames and J.C Southam et al., 2018). In our neighboring countries, the frequency of dental caries is quite high, documented to be 68%, 65% and 64% in China, Iran and India respectively. The prevalence of dental caries in Pakistan is also quite high, around 62%, which is associated with significant morbidity and economic consequences (Reddy K S, et al., 2017, Lu Liu et al., 2013) Dental caries basically involves contact between the tooth structure, the sugars and biofilm formed on the tooth surfaces (Pitts, N. B et al., 2016). The caries process composed of altering periods of demineralization and remineralization of tooth, which, if net demineralization happens over adequate time, results in the initiation of dental caries. The cause of dental caries is lactic acid produced by fermentation of sugars by oral bacteria (Banas and Drake., 2018). The normal pH level of saliva is 6.2- 7.6. At neutral pH, calcium and phosphate ions from the saliva incorporate into the enamel and maintain the structure of enamel, but when the pH level falls below normal, i.e. at 5.5 or below 5.5, the calcium and phosphate ions from the enamel leach out and causes the exchange of minerals ions from hydroxyapatite crystals of enamel into plaque, resulting in demineralization of tooth (J.V Soames Oral pathology 2018).

Dental caries management emphasizes on reducing tooth demineralization by changing eating habits, altering or inhibiting bacterial growth, changing the salivary pH level and buffering capacity (Khirtika et al., 2017, Velmurugan et al., 2013, Yang et al., 2018). Different antimicrobial synthetic mouthwashes, toothpastes, gels, chewing gums and varnishes have been used to improve mouth hygiene and prevent dental caries by aiming cariogenic microorganisms. The prevention of dental caries is done by mouth brushing after meal, by using fluoride toothpastes, antimicrobial mouthwashes, interdental cleaning aids, salivary stimulants (xylitol, mannitol), pit and fissure sealants, and application of topical fluoride on teeth surfaces. Mouth rinses also reduce gingival inflammation and inhibit plaque formation (Velmurugan et al., 2013, Chen and Wang, 2010, Zajkani et al., 2018). Mouthwashes have anticariogenic effects, but have certain disadvantages. They are costly, have side effects including staining of the teeth and burning sensation in the oral cavity (Nayak et al., 2012, Aoun et al., 2018).

Chlorhexidine is gold standard, commonly used and most effective chemical approach to decrease the accumulation of plaque. Daily rinsing mouth with chlorhexidine (0.2%) has been shown to reduce the growth rate of streptococcus mutans in the oral cavity (Velmurugan et al., 2013). However, it has certain side effects, i.e. oral mucosal erosion, parotid swelling, staining of teeth, burning feeling and bitter taste. (Jacob and Nivedhitha, 2018b, Shah et al., 2018, Van der Weijden et al., 2010, Nayak et al., 2012, Solderer et al., 2019) Many populations use medicinal plants as traditional or alternative treatments for various ailments due to their better safety profiles, health beneficial effects, lower cost and easy availability. Among the plant species used for medicinal purposes are those of the genus Morus, includes most commonly used species are Morus alba, rubra and nigra, that have also shown antimicrobial properties against various life threatening infections (Ercisli S et al., 2006). Morus alba commonly called as white mulberry, and it belongs to family Moraceae is otherwise called Tut, shahtoot or mulberry. Morus Alba (white mulberry) is native to China, India, Pakistan and Japan (Kumar V et al., 2008). In the current study, Morus alba fruit extract will be compared with chlorhexidine to Streptococcus mutans against oral pathogens due to its antimicrobial properties.

Statement of the problem Dental caries is highly prevalent across the globe including Pakistan; it causes tooth loss, malocclusion, and temporomandibular joint problems. The associated infections may carry risk of spreading into superficial and deep fascial spaces and, even may cause life threatening infections. Treatment of dental caries is quite expensive and poses an economic burden on our already deprived low socioeconomic population. So, there is need of exploration of natural products that may have antimicrobial and other beneficial effects to decrease the caries activity along with good safety profiles, easily available and cost-effective.

Research question Are the aqueous extracts of Morus alba fruit equally effective as chlorhexidine mouthwash for the prevention of dental caries? Objectives To compare the efficacy of Morus alba fruit extracts with chlorhexidine in patients having dental caries on the basis of reduction in counts of Streptococcus mutans in their saliva.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

盲法说明

Total number of groups = 3 Group 1 has been given chlorhexidine mouthwash and group 2nd and 3rd have been given 20% and 30% aqueous extract of morus alba fruit respectively.

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • All the patients of age 18-40 years at least 20 teeth in their mouth and not including wisdom teeth.
  • The patients of either gender. The patients with active and untreated carious lesions, (at least one carious tooth should be present in patient oral cavity).

排除标准

  • The patients undergoing orthodontic treatment The patients already taking antibiotic therapy or antimicrobial rinse. The patients having allergy to chlorhexidine mouthwash The patients whose consents could not be obtained

结局指标

主要结局

count of bacteria (streptococcus mutans)will be decrease

时间窗: 15 days

streptococcus mutans is the dental caries causing microorganism, in this study, the count of streptococcus mutans is measured before and after the use of respective mouthwash,the bacterial count decrease after the use of mouthwash, so primary outcome is that there is less chance of dental caries after use of respective mouthwash

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Eid Muhammad

M.Phil Trainee

Ziauddin University

研究点 (2)

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