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临床试验/CTRI/2025/07/092083
CTRI/2025/07/092083已完成不适用

Influence of metal base complete denture and soft lined complete denture on the salivary pH in edentulous patients before and after prosthetic intervention

Dr Chitralekha Maravi1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2025年8月15日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
34
试验地点
1
主要终点
The research may provide an information regarding the influence of metal base complete denture and denture relined with soft liner on salivary pH before and after insertion of the prosthesis

研究概览

简要总结

The patients reporting to Department of Oral and Maxillofacial Prosthodontics and Implantology Government Dental College Raipur, are selected as per mentioned inclusion and exclusion criteria. The selected patients will be informed regarding his or her participation in this study and the treatment procedure is properly explained. A written informed consent forms will be obtained. Proforma will be used to collect data of the patients regarding age, gender, address, chief complaint, past dental history, medical history. Subjects will be selected randomly and divided into 2 groups. Group A will include those patients for whom metal base complete denture is planned. The patients, planned for fabrication of the complete denture with soft liner, will be included in group B.

The complete denture with metal denture base and acrylic denture based lined with soft liner will be fabricated following all proper techniques and standard principles of prosthodontics. Unstimulated salivary pH will be estimated before delivery of denture at the day of denture insertion and after delivery of denture at the intervals of 1 month followed by 3 months using standardized spitting method. Patients will be instructed to refrain from eating, drinking, smoking 1hour prior to the saliva collection. Unstimulated saliva will be collected under standardized conditions between 9.00-11.00 AM. The Saliva will be collected into a container and salivary pH will be measured immediately after saliva collection using saliva pH meter. The values of salivary pH observed for subjects will be tabulated.

The complete denture with metal denture base and acrylic denture based lined with soft liner will be fabricated following all proper techniques and standard principles of prosthodontics. Unstimulated salivary pH will be estimated before delivery of denture at the day of denture insertion and after delivery of denture at the intervals of 1 month followed by 3 months using standardized spitting method. Patients will be instructed to refrain from eating, drinking, smoking 1hour prior to the saliva collection. Unstimulated saliva will be collected under standardized conditions between 9.00-11.00 AM. The Saliva will be collected into a container and salivary pH will be measured immediately after saliva collection using saliva pH meter. The values of salivary pH observed for subjects will be tabulated.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
40.00 Year(s) 至 85.00 Year(s)(—)
性别
All

入选标准

  • 1 Age including Middle and older age 2 Edentulous Patients 3 Systemically healthy subjects along patients with controlled diabetes and blood pressure 4 New or Past denture wearer but the denture is completely discontinued during new denture fabrication.

排除标准

  • 1 Patients suffering from uncontrolled diabetes and blood pressure 2 Patients under medications such as antidepressant and neuroleptic drug 3 Patients suffering from any salivary gland disorder.

结局指标

主要结局

The research may provide an information regarding the influence of metal base complete denture and denture relined with soft liner on salivary pH before and after insertion of the prosthesis

时间窗: Baseline

次要结局

  • It will help the researcher to recognize the possibility of salivary pH changes due to certain prosthetic rehabilitation to such an extent which may affect the oral and general health of the individuals as well as the sanity of denture prosthesis itself(Baseline)

研究者

发起方
Dr Chitralekha Maravi
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Chitralekha Maravi

Government Dental College Rajbandha Maidan path Raipur Chhattisgarh

研究点 (1)

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