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Deterioration of Resilient Denture Liners and Patient Characteristics

Primary Purpose

Xerostomia, Menopause, Kidney Disease

Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Evatouch Super
Sponsored by
Nihon University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an observational trial for Xerostomia

Eligibility Criteria

40 Years - 95 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • wearing maxillary complete dentures

Exclusion Criteria:

  • had been treated with a tissue conditioner, RDLs, and denture adhesives were excluded
  • showed obvious cognitive impairment
  • could not understand written or spoken Japanese

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Arm Label

    denture liners

    Arm Description

    Evatouch Super (EVA; Neo Dental Chemical products, Washington, USA), GC RELINE (GCR; GC Dental Products Corp, Tokyo, Japan), Mucopren soft (MCP; Kettenbach GmbH & Co KG, California, USA) Soften (SFT; KAMEMIZU CHEM, Osaka, Japan), FD Soft (FDS; KAMEMIZU CHEM, Osaka, Japan), and Bio Liner (BIO; Nissin Dental Products, Kyoto, Japan).

    Outcomes

    Primary Outcome Measures

    hardness
    Denture liners's hardness was measured using a Vesmeter® (WaveCyber Corp, Saitama ,Japan) at the out of oral cavity.

    Secondary Outcome Measures

    Salivary flow test(Unstimulated saliva)
    The participants were instructed to sit in an upright position with their heads inclined forward, which facilitated saliva collection at the floor of the mouth and overflow from the lip. The saliva was allowed to drip into a measuring cup for 5 min, and the flow rate was calculated in mL/min .
    Salivary flow test(Stimulated saliva)
    The participants were instructed to chew a piece of paraffin gum until it became soft. The first collection of saliva was swallowed, the timer was set, and chewing was continued for another 2 min .The participants spat out the saliva at short intervals into a measuring cup. The participants were instructed not to eat anything (drinking water was allowed), smoke, or take snuff at least two hours before the tests.

    Full Information

    First Posted
    October 26, 2015
    Last Updated
    December 26, 2016
    Sponsor
    Nihon University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02587676
    Brief Title
    Deterioration of Resilient Denture Liners and Patient Characteristics
    Official Title
    Changes in the Hardness of Resilient Denture Liners Embedded in Maxillary Complete Dentures and Their Association With Patient Characteristics
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    December 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2013 (undefined)
    Primary Completion Date
    July 2015 (Actual)
    Study Completion Date
    December 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Nihon University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Thirty complete maxillary denture wearers were recruited after obtaining informed consent. One investigator measured the Shore D hardness of the commercially available RDLs using a Vesmeter®. The salivary flow rates and pH values and the occlusal force were measured for all patients before initiation of the study. T-tests and Pearson's correlation coefficients were used for statistical analyses. A p-value of <0.05 was considered statistically significant.
    Detailed Description
    Participants This study was approved by the Human Ethics Committee of Nihon University School of Dentistry, Matsudo (EC 13-006). Thirty wearers of complete maxillary dentures (12 men; mean age, 71.8 ± 9.2 years and 18 women; mean age, 70.2 ± 10.7 years) who visited the Department of Removable Prosthodontics at our institute were recruited for this study. The volunteers were enrolled only after they provided written informed consent. Complete maxillary denture wearers who had been treated with a tissue conditioner, RDLs, and denture adhesives were excluded. Before starting the clinical trial, the participants were asked about the following environmental factors in a questionnaire: smoking, drinking, denture wearing during sleeping, and denture cleanser usage. After specimen making, all participants were instructed to wear their dentures as per their normal routine. Specimen Preparation A cylinder shapes six places with a 4-mm diameter and 2-mm depth , that was drilled into the inner surface of the denture base. Then, the RDL materials were mixed by each product, packed into the cavity, and polymerized at room temperature . The six commercial RDLs used in this study:Evatouch Super (EVA; Neo Dental Chemical products, Washington, USA), GC RELINE (GCR; GC Dental Products Corp, Tokyo, Japan), Mucopren soft (MCP; Kettenbach GmbH & Co KG, California, USA) Soften (SFT; KAMEMIZU CHEM, Osaka, Japan), FD Soft (FDS; KAMEMIZU CHEM, Osaka, Japan), and Bio Liner (BIO; Nissin Dental Products, Kyoto, Japan). Hardness was measured using a Vesmeter® (WaveCyber Corp, Saitama, Japan). When the probe, which included a built-in position sensor connected to a personal computer, was placed in a perpendicular orientation to an RDL, the indenter of the probe was depressed onto the RDL at a constant speed through electromagnetic power. Simultaneously, the path of the indenter was constantly traced by the position sensor. The computer processed electrical signals from the measuring device and calculated the Shore D hardness, which was the primary outcome in the present study. The same investigator measured the hardness at each appointment. The original hardness and the hardness at 1 month after oral exposure were used for analysis. Each specimen was measured five times, and the highest and lowest values were eliminated from the calculation of the mean representative value for each specimen. The specimens embedded in the dentures were measured on a hot plate to maintain the temperature at 37°C or as close to the oral temperature as possible. Statistical Analyses Before other statistical analyses, the normality of the data was tested using the Kolmogorov - Smirnov test, and then parametric statistical methods were applied.Two-way repeated measures analysis of variance ( ANOVA ) with the material type (EVA, MCP, GCR, FDS, SFT, and BIO) and time period (baseline and one month after) as factors was used to assess changes in the hardness of the six RDLs over time. The Tukey-Kramer test was used as a post hoc test after the two-way repeated measures ANOVA .The effects of categorical variables such as sex, smoking, drinking, denture wearing during sleeping, and denture cleanser usage on the hardness of the RDLs were analyzed using a two-way ANOVA without a post hoc test; we were not interested in comparing each RDL but rather in analyzing the effects of categorical variables on the RDLs. The effects of continuous variables, including age, salivary flow rate, and occlusal force, were analyzed using Pearson's correlation coefficients. All statistical analyses were performed using IBM® SPSS® Statistics 21 (IBM, Armonk, NY, USA). A p-value of <0.05 was considered statistically significant.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Xerostomia, Menopause, Kidney Disease

    7. Study Design

    Enrollment
    100 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    denture liners
    Arm Description
    Evatouch Super (EVA; Neo Dental Chemical products, Washington, USA), GC RELINE (GCR; GC Dental Products Corp, Tokyo, Japan), Mucopren soft (MCP; Kettenbach GmbH & Co KG, California, USA) Soften (SFT; KAMEMIZU CHEM, Osaka, Japan), FD Soft (FDS; KAMEMIZU CHEM, Osaka, Japan), and Bio Liner (BIO; Nissin Dental Products, Kyoto, Japan).
    Intervention Type
    Other
    Intervention Name(s)
    Evatouch Super
    Other Intervention Name(s)
    GC RELINE, Mucopren soft, Soften, FD Soft, Bio Liner
    Intervention Description
    The deterioration of RDLs may differ between in vitro conditions and the conditions encountered in denture wearers. We conducted an in vivo study to investigate how resilient denture liners (RDLs) changed in hardness when embedded in complete maxillary dentures worn by patients for one month in a clinical setting. We hypothesized that the hardness one month after application of the RDLs would be affected by the age, the condition of the saliva, the occlusal force, type of denture used, the patients habits related to smoking, drinking, wearing dentures while sleeping, and using a denture cleanser.
    Primary Outcome Measure Information:
    Title
    hardness
    Description
    Denture liners's hardness was measured using a Vesmeter® (WaveCyber Corp, Saitama ,Japan) at the out of oral cavity.
    Time Frame
    10 min
    Secondary Outcome Measure Information:
    Title
    Salivary flow test(Unstimulated saliva)
    Description
    The participants were instructed to sit in an upright position with their heads inclined forward, which facilitated saliva collection at the floor of the mouth and overflow from the lip. The saliva was allowed to drip into a measuring cup for 5 min, and the flow rate was calculated in mL/min .
    Time Frame
    5 min
    Title
    Salivary flow test(Stimulated saliva)
    Description
    The participants were instructed to chew a piece of paraffin gum until it became soft. The first collection of saliva was swallowed, the timer was set, and chewing was continued for another 2 min .The participants spat out the saliva at short intervals into a measuring cup. The participants were instructed not to eat anything (drinking water was allowed), smoke, or take snuff at least two hours before the tests.
    Time Frame
    2min
    Other Pre-specified Outcome Measures:
    Title
    pH measurement
    Description
    The pH values of the resting and stimulated saliva were obtained using a pH testing device (pH Spear, Eutech Instruments Pte Ltd, Ayer Rajah Crescent, Singapore). The investigator dipped the electrode approximately 2 to 3 cm into the saliva in a measuring cup and recorded the digitally obtained value.
    Time Frame
    5 min
    Title
    Occlusal force measurement
    Description
    A GM10 occlusal force meter (Nagano Keiki, Tokyo, Japan) was used to measure the occlusal force. The maximum occlusal force applied by the functioning left and right first molars was measured three times, and the mean was used as a representative value.
    Time Frame
    5 min
    Title
    Questionnaire
    Description
    Before starting the clinical trial, the participants were asked about the following environmental factors in a questionnaire: smoking, drinking, denture wearing during sleeping, and denture cleanser usage.
    Time Frame
    10 min

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    95 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: wearing maxillary complete dentures Exclusion Criteria: had been treated with a tissue conditioner, RDLs, and denture adhesives were excluded showed obvious cognitive impairment could not understand written or spoken Japanese
    Study Population Description
    The patient of wearing complete maxillary dentures who visited the Department of Removable Prosthodontics at our institute were recruited for this study. The volunteers were enrolled only after they provided written informed consent.
    Sampling Method
    Non-Probability Sample
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Akina Ogawa
    Organizational Affiliation
    Depertment of removable prosthodontics Nihon University School of Dentistry at Matsudo
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    17165299
    Citation
    Kimoto S, So K, Yamamoto S, Ohno Y, Shinomiya M, Ogura K, Kobayashi K. Randomized controlled clinical trial for verifying the effect of silicone-based resilient denture liner on the masticatory function of complete denture wearers. Int J Prosthodont. 2006 Nov-Dec;19(6):593-600.
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    Deterioration of Resilient Denture Liners and Patient Characteristics

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