A Phase 4 interventional study of CPP-ACP and Placebos in Dental Erosion, sponsored by Fujian Medical University. Completed. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-02-08.
Sponsored by Fujian Medical University · Phase 4, Interventional, and Prevention
40 specimens were prepared from fresh-extracted human molars and further embedded using the acrylic resin. Specimens were randomly divided into 2 groups according to the treatment before in vivo erosion (n=20): CPP-ACP for 3 min (CPP-ACP group) and deionized water for 3 min (control group). 10 healthy volunteers were recruited and customized maxillary appliance containing 4 specimens (2 from CPP-ACP group and 2 from control group) was fabricated for each volunteer. Participants were instructed to drink 150 ml cola in 5 min using the gargling method after placing appliances intraorally for 2 h. The in vivo attacks were performed 4 X 5 min with 1-h interval daily over 7 d. The surface microhardness and surface microstructure of the specimens were evaluated at the baseline and after the treatment. The data were statistically analyzed using three-way ANOVA and post hoc tests. Data were considered statistically significant at a level of P \<0.05.
47 studies on the registry are indexed under Tooth Erosion; 7 are open to participants now.
This study's enrollment of 12 is below the median of 33 across 33 interventional studies indexed under Tooth Erosion.
Browse Tooth Erosion studies →Fujian Medical University is the lead sponsor of 148 studies on the registry; 52 are open to participants now.
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Exclusion Criteria:
Tooth mousse (GC, Japan) application on the specimen surface for 3 min.
Drug: CPP-ACP
Deionized water application on the specimen surface for 3 min
Drug: Placebos
The surfaces of specimens were pretreated with CPP-ACP for 3 min
The surfaces of specimens were pretreated with deionized water for 3 min
Surface microhardness
a Vickers microhardness tester with microscopic lens was used, with a 100 g load and 30-s dwell time. Three microhardness measurements were obtained on the top surface of each specimen.
Time frame: baseline
Surface microhardness
a Vickers microhardness tester with microscopic lens was used, with a 100 g load and 30-s dwell time. Three microhardness measurements were obtained on the top surface of each specimen.
Time frame: 7 days
No study locations are listed for this record.
Plan to share: Undecided
This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Casein phosphopeptide-amorphous calcium phosphate nanocomplex