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临床试验/CTRI/2023/06/053795
CTRI/2023/06/053795已完成3 期

Clinical Evaluation of the efficacy of Phosphorylated Chitosan as Cavity Disinfectant in Carious Primary Molars

Dr Sreejeeta Dey1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2023年6月20日最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
96
试验地点
1
主要终点
To assess & compare the increase or decrease in bacterial activity with the use of p-chitosan & conventional chlorhexidine cavity disinfectants by measuring mean carious lesion area using fluorescence image analysis

研究概览

简要总结

Dental caries is the among the commonest and highly prevalent diseases worlwide affecting 486million children with primary teeth and 2.4billion adults with permanent teeth globally.According to WHO, dental caries affects 60–90 % of schoolchildren globally, mainly in developing countries resulting in pain,infections,undernutrition thereby affecting growth and development and decrease in overall quality of life.Therefore it is of utmost importance to treat effectively and prevent dental caries from progressing, at an earlier stage, to avoid all the complications.The ideal way of treating moderately affected carious tooth is by removing the bacteria by cavity preparation followed by a cement or resin-based dental restoration.

However,the complete eradication of bacteria prior to insertion of restoration plays an important role in determining the longevity of the restoration and correspondingly the success of the treatment. Bacteria can remain viable on the dentinal surface even after cavity preparation. They may survive and multiply in the presence of microleakage, which may lead to pulpal irritation, risk of recurrent caries and/or postoperative sensitivity and ultimately failure of the restoration. Attempts at the complete removal of deep carious dentin, by solely mechanical means, may result in pulp exposure and gross destruction of the tooth structure.

To cope up with the above drawbacks, the concept of cavity disinfection has been introduced by some authors, which involves cleansing of the cavity with antimicrobial agents prior to placement of restoration. Multiple disinfectants(CHX,NaOCl,Laser,Ozone,Propolis etc.) have been used in clinical dentistry, to reduce or eliminate bacterial load and sterilize dentin during cavity preparation.

Chlorhexidine digluconate in the form of 2% aqueous solution has been  widely considered as a  biocompatible,effective and toxicologically safe disinfectant.

Chitosan, derived from the deacetylation of chitin, obtained from the shells of marine crustaceans is a natural nontoxic, biocompatible, biodegradable polysaccharide with tested antibacterial properties. Prior studies have described the antimicrobial potential of chitin, chitosan, and their derivatives against Streptococcus mutans and other streptococci bacteria. Among these derivatives, phosphorylated chitosan(p-chitosan) exhibits bactericidal, bioabsorbable, osteoinductive, and metal chelating properties. Since phosphate groups of p-chitosan can bind calcium ions to form nucleating sites, p-chitosan would induce the formation of a calcium phosphate layer favouring remineralization of the carious lesion.

The aim of the present study is to evaluate the efficacy of p-chitosan as a potential cavity disinfectant which can decrease the bacterial load in the cavity and asses using fluorescence imaging and also compare the results with that of conventional 2%chlorhexidine disinfectant in retention and longevity of restorations.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Participant Blinded

入排标准

年龄范围
5.00 Year(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • •1.Mandibular and maxillary primary molars 2.Moderately deep cavities (ICDAS II caries score 4,5,6) limited to single-surface occlusal lesions and two-surface lesions (mesial-occlusal, MO or distal-occlusal, DO) without buccal/lingual extension 3.systemically healthy and cooperative children(Frankl scale 3 and 4) Radiographic criteria: 4.Lesions involving enamel and not more than half the dentinal thickness with two-third of remaining root length.

排除标准

  • •1.Systemic illness 2.Patients undergoing orthodontic treatment 3.Carious lesions involving pulp with/without root resorption and mobility 4.Re-restorations/hypomineralised teeth 5.Uncooperative patients(Frankl scale 1 and 2) Withdrawal criteria: 6.Development of allergy.

结局指标

主要结局

To assess & compare the increase or decrease in bacterial activity with the use of p-chitosan & conventional chlorhexidine cavity disinfectants by measuring mean carious lesion area using fluorescence image analysis

时间窗: 1 month

次要结局

  • To evaluate & compare the efficacy of p-chitosan cavity disinfectant with that of conventional chlorhexidine disinfectant in the retention and longevity of a dental restoration using FDI clinical scoring criteria(6 months)

研究者

发起方
Dr Sreejeeta Dey
申办方类型
Other [self-funded]

研究点 (1)

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