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临床试验/CTRI/2024/04/065264
CTRI/2024/04/065264已完成2/3 期

Efficacy of repeated immersion of maxillary acrylic dental prostheses in sodium hypochlorite solution before trimming in controlling microbial load - a randomized controlled trial

Dr Kavitha Janardanan1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2024年4月15日最近更新:

试验速览

阶段
2/3 期
状态
已完成
发起方
入组人数
36
试验地点
1
主要终点
Microbial load in terms of colony count on the surface of acrylic dental prosthesis

研究概览

简要总结

Materials and Methods:

Completely and partially edentulous patients wearing maxillary prosthesis requiring denture adjustments, who satisfy the inclusion and exclusion criteria will be selected for the study. The acrylic denture prostheses will be randomly assigned to two groups - Group 1 and Group 2. Group 1 will be subjected to Conventional disinfection protocol and Group 2 to modified disinfection protocol. Care is taken to keep the number of each type of prostheses ( RPD and CD) equal in both the groups for comparability.

Conventional Disinfection Protocol

The dental personnel after donning appropriate personal protective gears, including gloves, masks, goggles, apron and face shield, will remove the acrylic prosthesis from the patients mouth and swab the palatal intaglio surface to estimate the contamination level of the prosthesis. Patient is then instructed to clean the denture with a soft toothbrush. Following which the prostheses will be disinfected by immersion in 0.5% sodium hypochlorite solution for 20 min. Patients will be instructed to rinse the mouth for 30 seconds with 10ml of 1% povidone iodine mouthwash followed by insertion of the prosthesis in the mouth for 1 min to address patient complaint.  The dental personnel will perform the trimming on dental lathe using tungsten carbide cross cut acrylic trimmer for 1 min at 6500rpm followed by washing in sterile distilled water  for 30 sec to remove acrylic debris. This cycle of insertion and trimming  will be repeated twice more. At the end of third cycle  swab will be collected again.

Modified Disinfection Protocol

Preparation of the patient and the prosthesis is done as in the Conventional disinfection protocol.  Unlike the conventional protocol, the acrylic denture prosthesis will be immersed in 1.0 % sodium hypochlorite solution for one minute and thereafter washed in sterile distilled water  for 30 seconds before it is trimmed. This cycle of insertion, disinfection, washing and trimming is repeated twice more. At the end of third cycle  swab will be collected again.

Collection of Samples for Microbiology

Samples will be  collected with sterile cotton-tipped swabs from the acrylic prosthesis along a 1.5inch x 1.5inch flat  surface of the intaglio in a rolling fashion for 60 seconds and then plated onto the culture media. The co-investigator will use a stop watch for monitoring the time.

Microbiological Analysis

Microbiological analysis will be performed to isolate and identify common oral gram positive and gram negstive  bacteria and Candida species. Swabs will cultured onto blood agar (BA) for microbial count and MacConkey agar for aerobic Gram-negative bacteria (AGNB).

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
40.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Patients wearing Maxillary Acrylic Dental Prostheses for a continuous period of more than 2 months.

排除标准

  • Patients who have been treated with systemic antibiotics during the past 2 months Patients with acute and chronic respiratory illness.
  • Patients with infections of the soft tissues of the oral cavity, sinonasal cavity, nasopharynx and larynx.
  • Patients with uncontrolled chronic systemic diseases like diabetes, immunosuppressive states like retroviral infection, chemotherapy for malignancy, individuals who received organ transplant and are on immunosuppresants, individuals who have undergone irradiation for oromaxillofacial malignancies.
  • Patients with xerostomia Patients with Maxillofacial prostheses Patients who require less than 3 cycles of trimming and insertion.

结局指标

主要结局

Microbial load in terms of colony count on the surface of acrylic dental prosthesis

时间窗: 2 hours

次要结局

  • Identifying the individual organisms on maxillary acrylic prosthesis & evaluation of how their count varies following conventional & repeated immersion protocols(2 hours)

研究者

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

Kavitha Janardanan

Govt Dental College, Thiruvananthapuram

研究点 (1)

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