CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 150 enrolled
Drug / intervention
S-PRG filler +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02460562
NCT02460562N/ACompleted

The Caries Prevention Effect of Surface Pre-reacted Glass-ionomer Filler Incorporated in Denture Base Resins on Edentulous Elderly People

Kritirat Kiatsirirote·interventional·Posted Jun 2, 2015·Updated Jun 3, 2019

In Brief

A clinical study evaluating S-PRG filler and PMMA resin for Dental Caries. Completed, enrolled 150 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDental Caries
CountriesThailand

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 2, 2015
Enrollment StartJun 1, 2015
Primary CompletionAug 30, 2016
Study CompletionJan 20, 2017
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 11.1 years ago

Interventions

S-PRG fillerdevice

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.

PMMA resindevice

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.