Deterioration of Resilient Denture Liners and Patient Characteristics

NCT ID: NCT02587676

Last Updated: 2016-12-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2016-12-31

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

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.

Conditions

Xerostomia; Menopause; Kidney Disease

Study Groups

denture liners

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).

Evatouch Super

Intervention Type: OTHER

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.

Interventions

Evatouch Super

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.

Intervention Type: OTHER

Other Intervention Names

GC RELINE; Mucopren soft; Soften; FD Soft; Bio Liner

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nihon University

OTHER

Sponsor Role: lead

Responsible Party

Yasuhiko Kawai

Professor Dr.Yasuhiko kawai

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Akina Ogawa

Role: PRINCIPAL_INVESTIGATOR

Depertment of removable prosthodontics Nihon University School of Dentistry at Matsudo

References

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.

Reference Type: BACKGROUND

PMID: 17165299 (View on PubMed)

Other Identifiers

EC13-006

Identifier Type: -

Identifier Source: org_study_id