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Caries Prevention Effect of S-PRG Filler Incorporated in Denture Base Resins on Edentulous Elderly People

NCT02460562 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2019-06-03

Study results available
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Summary

The purpose of this study is to determine whether a novel material of S-PRG fillers containing in a daily-used resin denture base and their capability of fluoride release and recharge to elevate the salivary fluoride level and prevent dental caries in Thai middle-aged patients between 35-60 years of age who wear the resin denture.

Conditions

  • Dental Caries

Interventions

DEVICE

S-PRG filler

Surface pre-reacted glass-ionomer (S-PRG) filler is a new type of biological material. This new material is being used in the formulation of dental product as filling materials. It has an anti-plaque effect which will release ions to alter the pH of the surrounding environment when it comes into contact with water or acidic solutions. These ions will exert their effect on caries prevention. The amount of S-PRG filler that is put in the standard resin denture base is 20% by weight. They are incorporated into the resin denture base and maintain the mechanical properties as required by ISO 1567.

DEVICE

PMMA resin

Polymethyl methacrylate (PMMA) resins have been used for the fabrication of resin denture base for 50 years. The advantages of PMMA resin that most notably is the ease of fabrication with very simple equipment but a limitation is the fragility because of its physical properties that include low flexural strength and surface hardness.

Sponsors & Collaborators

Principal Investigators

  • Timothy A DeRouen, PhD · Forgaty International Center,NIH

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2016-08-30
Completion
2017-01-20

Countries

  • Thailand

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02460562 on ClinicalTrials.gov