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临床试验/NCT04942262
NCT04942262已完成3 期

Identifying Diagnostic Criteria of Denture Adhesive Use in Complete Denture Wearers: A Quasi-experimental Study

Chulalongkorn University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2019年1月31日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
80
试验地点
1
主要终点
Oral health-related quality of life (OHRQoL)

研究概览

简要总结

80 complete denture (CD) wearers participated in the quasi-experimental study. Two outcomes were: 1) oral health-related quality of life (OHRQoL) assessed using the Oral Impacts on Daily Performances index, and 2) masticatory performance, determined by a peanut particle size after 20-stroke mastication. Denture retention and stability were evaluated using the Chulalongkorn University (CU)-modified Kapur method to classify the CD into acceptable or unacceptable quality. Data were collected at 3-time points: 1) at baseline (T0), 2) after a 1-month trial of denture adhesive (DA) use (T1), at which time the participants decided whether to continue using DA, and 3) 1-month after continued or discontinued using DA (T2).

详细描述

Participants The eligible participants were CD wearers randomly recruited from patients who visited the Prosthodontic clinic at the Faculty of Dentistry, Chulalongkorn University from 2015 to 2019. The inclusion criteria were patients who had worn removable maxillary and mandibular CDs for at least 6 months. The patients who wore a metal-based denture, had a history of DA use, had difficulty in responding to the interview, or were unwilling to follow the study protocol were excluded from the study.

Outcomes The primary outcome was OHRQoL determined using the Thai-version of Oral Impacts on Daily Performances index. The participants were interviewed whether they had difficulties in performing the following 8 daily activities: eat, speak, clean denture and mouth, sleep, smile, emotional stability, social contact, and carry out work or housework. The frequency and severity of each impact were rated using a five-point Likert scale, and their multiplication gave a condition-specific impact score. The overall oral impact score was the sum of all 8 activity scores. The prevalence of an oral impact was categorized into absence (score = 0) or presence of an oral impact (score > 0). The changes in oral impact score from T0 to T1 were categorized into 3 types: decreased (T0 score > T1 score), increased (T0 score < T1 score), and remained absent (T0 score = T1 score = 0).

The secondary outcome was masticatory performance assessed using the multiple sieve method of peanut mastication. The participants masticated 3 grams of roasted peanuts for 20 strokes in triplicate with a 15-minute resting interval between each test. The comminuted peanut particles were dried and sieved through 12 standard test sieves (Test sieve; Retcsh Technology GmbH) on a vibrating sieve shaker. A simple linear regression was plotted between the cumulative weight and diameter of each sieve test. The median peanut particle size (mm) was the sieve diameter through which 50% of the comminuted peanut particles passed. A smaller peanut particle size reflected a higher masticatory performance.

Intervention An external prosthodontist provided a cream-type DA (Polident®, GlaxoSmithKline, Ireland), and instructed the participants to use the DA cream once a day in the morning and use it throughout the day. They applied the DA onto maxillary and mandibular dentures on the tissue surface using a spot method. The participants had to remove the DA and clean the denture every day after the last meal by soaking and brushing the CD with liquid soap and a soft toothbrush under running tap water. Two gauze pads were used to remove DA from the denture and oral mucosa.

The OHRQoL, masticatory performance, and CD-quality were evaluated at 3-time points:

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

盲法说明

An external prosthodontist provided with a denture adhesive and knew who continued using denture adhesive.

Meanwhile, the outcome assessor did not notice whether the participants continue using denture adhesive

入排标准

年龄范围
40 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Wear removable maxillary and mandibular complete dentures for at least 6 months.

排除标准

  • Wear a metal-based denture
  • Have a history of DA use
  • Unable to respond to the interview
  • Unwilling to follow the study protocol.

研究组 & 干预措施

denture adhesive use

Experimental

Participants were instructed to use a cream-type denture adhesive (Polident®, GlaxoSmithKline, Ireland) once a day in the morning and use it throughout the day. They applied denture adhesive onto the tissue surface of their maxillary and mandibular dentures using a spot method. The participants had to remove the DA and clean the denture every day after the last meal by soaking and brushing the CD with liquid soap and a soft toothbrush under running tap water. Two gauze pads were used to remove DA from the denture and oral mucosa. After the 1-month trial period of DA use. The outcomes were evaluated with all participants using DA, and they had to choose whether they wanted to continue or discontinue using DA for another 1 month. At 1-month after continuing or discontinuing DA use. At this time, some participants used DA during the outcome evaluations, while some did not, depending on the patient's decision on DA use.

干预措施: denture adhesive (Polident®, GlaxoSmithKline, Ireland) (Drug)

结局指标

主要结局

Oral health-related quality of life (OHRQoL)

时间窗: 2 months

The OHRQoL was assessed using the oral impacts on daily performances (OIDP) index. The participants were interviewed about whether they had difficulties in performing the following 8 daily activities within physical, psychological and social performances: eating, speaking and pronouncing, cleaning denture and mouth, sleeping, smiling, emotional stability, social contact, and carrying out work or housework. The frequency and severity of each impact were rated using a five-point Likert scale, and their multiplication gave a condition-specific (CS) impact score. The overall oral impact score was the sum of all 8 activity scores. The prevalence of an oral impact was categorized into absence (score = 0) or presence of an oral impact (score \> 0).

次要结局

  • Masticatory performance using the multiple sieve method of peanut particle.(2 months)

研究者

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

Nareudee Limpuangthip, DDS, PhD

Dental staff at Department of Prosthodontics

Chulalongkorn University

研究点 (1)

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