Caries Prevention Effect of S-PRG Filler Incorporated in Denture Base Resins on Edentulous Elderly People
The Caries Prevention Effect of Surface Pre-reacted Glass-ionomer Filler Incorporated in Denture Base Resins on Edentulous Elderly People
1 other identifier
interventional
150
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2015
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 28, 2015
CompletedStudy Start
First participant enrolled
June 1, 2015
CompletedFirst Posted
Study publicly available on registry
June 2, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 20, 2017
CompletedResults Posted
Study results publicly available
June 3, 2019
CompletedJune 3, 2019
February 1, 2019
1.2 years
May 28, 2015
September 28, 2017
February 18, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Saliva Fluoride Concentration (Part Per Million,Ppm)
Whole mixed saliva was collected by passive drooling into individual plastic vials to a volume of 2 ml while wearing the denture to determine the capacity for fluoride release and recharge from the denture. Saliva fluoride concentrations (ppm) were assessed at multiple time points (baseline, days 1, 14, 15, and 3 months and 1.5 years) to compare with baseline concentration under the conditions that the participants wear the resin denture at least 1 hour and refrain from tooth brushing at least 2 hours before saliva sampling. The salivary fluoride content (ppm) of each solution was determined using a fluoride ion electrode (item number 27502-19, Cole-Palmer, USA) connected to a 710 A plus fluoride ion meter (item number 067952, Thermo Orion, USA).
on days 1, 14, 15, and 3 months and 1.5 years of wearing the denture
Secondary Outcomes (1)
Assessment of Enamel Caries
Baseline and 1.5 years of follow up
Study Arms (2)
PMMA resin
ACTIVE COMPARATORA denture base will be made with PMMA resin as a standard material.
PMMA resin & S-PRG filler
EXPERIMENTALA denture base will be made from PMMA resin \& S-PRG filler for subject to wear.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Compliance: Understands and is willing, able and likely to comply with all study procedures and restrictions
- General Health: Good general health with no clinically significant and/or relevant abnormalities of medical history or oral examination that could interfere with subject safety during the study period
- Salivary Flow: Have a salivary flow rate in the range of normal values (unstimulated whole saliva flow rate \> 0.15 ml/minute; gum base stimulated saliva flow rate ≥ 1 ml/minute)
- Oral condition: a) At least 6 teeth remaining natural upper teeth in good condition, including at least 2 posterior teeth. b) Adequate remaining natural or artificial lower teeth for proper function. c) Do not use fluoride supplement excluding toothpaste. and d) Present of caries risk or filling at least 1 surface.
You may not qualify if:
- Exhibited signs of xerostomia
- Serious oral pathology (e.g. extensive dental caries, periodontal disease)
- Pregnant or lactating women
- Frequent mouthwash or fluoride supplement use
- Unable to have basic self-care ability (including oral hygiene practice)
- History of allergies, metabolic diseases such as diabetes, or other medical conditions that could interfere with the study.
- Be caries free in oral cavity
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kritirat Kiatsirirotelead
- University of Washingtoncollaborator
Study Sites (3)
Health Promotion Center 1
Bang Khen, Bangkok, 10220, Thailand
Thammasat Hospital
Khlong Luang, Changwat Pathum Thani, 12121, Thailand
Krathumbaen Hospital
Samut Sakhon, Samutsakorn, 74110, Thailand
Related Publications (4)
Kamijo K, Mukai Y, Tominaga T, Iwaya I, Fujino F, Hirata Y, Teranaka T. Fluoride release and recharge characteristics of denture base resins containing surface pre-reacted glass-ionomer filler. Dent Mater J. 2009 Mar;28(2):227-33. doi: 10.4012/dmj.28.227.
PMID: 19496404BACKGROUNDMukai Y, Kamijo K, Fujino F, Hirata Y, Teranaka T, ten Cate JM. Effect of denture base-resin with prereacted glass-ionomer filler on dentin demineralization. Eur J Oral Sci. 2009 Dec;117(6):750-4. doi: 10.1111/j.1600-0722.2009.00678.x.
PMID: 20121940BACKGROUNDMa S, Imazato S, Chen JH, Mayanagi G, Takahashi N, Ishimoto T, Nakano T. Effects of a coating resin containing S-PRG filler to prevent demineralization of root surfaces. Dent Mater J. 2012;31(6):909-15. doi: 10.4012/dmj.2012-061.
PMID: 23207194BACKGROUNDKiatsirirote K, Sitthisettapong T, Phantumvanit P, Chan DCN. Fluoride-Releasing Effect of a Modified Resin Denture Containing S-PRG Fillers on Salivary Fluoride Retention: A Randomized Clinical Study. Caries Res. 2019;53(2):137-144. doi: 10.1159/000490627. Epub 2018 Jul 27.
PMID: 30056451DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Kritirat Kiatsirirote
- Organization
- Faculty of Dentistry, Thammasat University
Study Officials
- STUDY DIRECTOR
Timothy A DeRouen, PhD
Forgaty International Center,NIH
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Dentistry
Study Record Dates
First Submitted
May 28, 2015
First Posted
June 2, 2015
Study Start
June 1, 2015
Primary Completion
August 30, 2016
Study Completion
January 20, 2017
Last Updated
June 3, 2019
Results First Posted
June 3, 2019
Record last verified: 2019-02
Data Sharing
- IPD Sharing
- Will share