N/A
N=150
Caries Prevention Effect of S-PRG Filler Incorporated in Denture Base Resins on Edentulous Elderly People
Dental Caries
Bottom Line
View on ClinicalTrials.gov: NCT02460562 ↗Enrolled (actual)
150
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcome: Primary: Saliva Fluoride Concentration (Part Per Million,Ppm) — 0.05; 0.05; 0.09; 0.22 part per million,ppm — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- S-PRG filler (Device); PMMA resin (Device)
- Age
- Adult · 35+ yrs
- Sex
- All
- Sponsor
- Kritirat Kiatsirirote
- Primary completion
- Aug 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Saliva Fluoride Concentration (Part Per Million,Ppm) |
0.05; 0.05; 0.09; 0.22; 0.06; 0.06 | <0.05 sig |
| SECONDARY Assessment of Enamel Caries |
3353; 3402; 170; 77 | <0.05 sig |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02460562). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.