Deterioration of Resilient Denture Liners and Patient Characteristics

NCT02587676 | Completed

• 1 other identifier: EC13-006
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Xerostomia; Menopause; Kidney Disease

Outcome Measures

Primary Outcomes (1)

• hardness

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

  10 min

Secondary Outcomes (2)

• Salivary flow test(Unstimulated saliva)

  5 min

• Salivary flow test(Stimulated saliva)

  2min

Other Outcomes (3)

• pH measurement

  5 min

• Occlusal force measurement

  5 min

• Questionnaire

  10 min

Study Arms (1)

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).

Other: Evatouch Super

Interventions

Evatouch Super 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.

Also known as: GC RELINE, Mucopren soft, Soften, FD Soft, Bio Liner

denture liners

Eligibility Criteria

• Age: 40 Years - 95 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• wearing maxillary complete dentures

You may not qualify if:

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

Sponsors & Collaborators

• Nihon University: lead

Related Publications (1)

• 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.

  PMID: 17165299 BACKGROUND

MeSH Terms

Conditions

Xerostomia; Kidney Diseases

Condition Hierarchy (Ancestors)

Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Akina Ogawa

  Depertment of removable prosthodontics Nihon University School of Dentistry at Matsudo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Dr.Yasuhiko kawai

Study Record Dates

• First Submitted: October 26, 2015
• First Posted: October 27, 2015
• Study Start: June 1, 2013
• Primary Completion: July 1, 2015
• Study Completion: December 1, 2016
• Last Updated: December 28, 2016

Record last verified: 2016-12