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XerostomiaNCT02587676

Deterioration of Resilient Denture Liners and Patient Characteristics

An observational study of Xerostomia and Menopause, run by Nihon University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 95 yearsHealthy volunteers can take part
Conditions the study is for
Xerostomia, Menopause, Kidney Disease
What is being tested?
Evatouch Super
How many people
100 participants
Where
No sites listed yet
Study dates
Jun 2013to Dec 2016
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 95 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: 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.

Who may be able to join

  • wearing maxillary complete dentures

Who cannot join

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

About this study

Official title: Changes in the Hardness of Resilient Denture Liners Embedded in Maxillary Complete Dentures and Their Association With Patient Characteristics

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.

Read the detailed description
  1. 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.
  2. 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.
  3. 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.
Being tested
Evatouch Super
Medical subject headings
Xerostomia, Kidney Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Evatouch SuperOther

    Also called GC RELINE, Mucopren soft, Soften, FD Soft

    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.

Study groups in NCT02587676
Study groupRoleWhat they receive
denture linersEvatouch 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).
Receives: Other: Evatouch Super

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. hardness

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

    Measured: 10 min

Secondary outcomes (2)

  1. 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 .

    Measured: 5 min

  2. 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.

    Measured: 2min

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Oct 2015 (estimated)
  2. Study startJun 2013
  3. Primary completionJul 2015
  4. Study completionDec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02587676
Sponsor's protocol ID
EC13-006
Status last verified
Dec 2016
First submitted
26 Oct 2015
Last updated
28 Dec 2016
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 17165299

Questions about this trial

What is this clinical trial studying?

An observational study of Xerostomia and Menopause, run by Nihon University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

hardness (time frame: 10 min). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02587676, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2016.

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