Fluoride Concentration in Inter-proximal Fluid From Dental Sealants
- Conditions
- Caries
- Interventions
- Other: sealant application
- Registration Number
- NCT01588210
- Lead Sponsor
- Università degli Studi di Sassari
- Brief Summary
The hypothesis of this study is that the concentration of fluoride in oral interproximal fluids would increase more after using high-viscosity GIC as pit and fissure sealant, compared to Resin-Based sealants containing fluoride and RB sealants without fluoride content. To validate this hypothesis a randomized clinical trial was designed and performed in schoolchildren in order to evaluate fluoride release in inter-proximal fluid in vivo after the placement of three types of sealants: high-viscosity GIC, Resin-Based sealants containing fluoride and RB sealants without fluoride content.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2776
- The inclusion criteria are: year of birth between 2000 and 2002, informed consent signed by parents/guardians, presence of at least two permanent first molars completely erupted.
- The exclusion criteria are: demineralized lesions and hypomineralized permanent molar, carious lesions or presence of filling on the occlusal surface of the first permanent molar, fixed orthodontic treatment.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Glass Ionomer Cement group sealant application a high-viscosity glass-ionomer cement (KETAC™ MOLAR APLICAP 3M Espe, Germany) Resin Based Fluoride Group sealant application white photopolymerizable Resin-Based sealant containing fluoride (Helioseal F®, Ivoclar Vivadent AG, Fürstentum Liechtenstein) Resin Based sealant sealant application white photopolymerizable Resin-Based sealant (Concise 1930TM 3M Espe, Germany)
- Primary Outcome Measures
Name Time Method Inter-proximal fluid fluoride concentration 21 days after application Inter-proximal fluid was collected with a paper point in the mesial inter-proximal space of the sealed tooth for 15 seconds. Each sample was prepared for the analysis as follow: added of 0.5 ml TISAB III to reach a pH 5 and shaken with magnetic stirrer thermostated at 25°C for 15 seconds. 100 ml of the solution was then placed on a Petri dish for the analysis. Fluoride concentration was carried out with an Orion model 96.09 fluoride ion selective electrode and an Orion model 900200 double junction plastic body Ag/AgCl reference electrode with an Orion model 290 mV digital meter.
- Secondary Outcome Measures
Name Time Method caries incidence 24 months measurement of tooth caries at D1, D2 D3 level (both enamel and dentinal caries)
Trial Locations
- Locations (2)
Department of Surgery, Microsurgery and Medicine Sciences University of Sassari
🇮🇹Sassari, Sardinia, Italy
WHO CC University of Milan
🇮🇹Milan, Italy