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NCT03426150

Casein Phosphopeptide--amorphous Calcium Phosphate on Human Enamel Subjected to in Vivo Acid Attacks

Completed Phase 4 Last updated 8 February 2018
What this trial tests

Phase 4 trial testing CPP-ACP in Dental Erosion in 12 participants. Completed in 5 February 2018.

Timeline
25 December 2015
Primary endpoint
25 October 2017
5 February 2018

Quick facts

Lead sponsorFujian Medical University
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingsingle
Primary purposeprevention
Enrollment12
Start date25 December 2015
Primary completion25 October 2017
Estimated completion5 February 2018

Drugs / interventions tested

Conditions studied

Sponsor

Fujian Medical University

Who can join

Adults 18 to 60, any sex, with Dental Erosion. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. In situ effect of Tooth Mousse containing CPP-ACP on human enamel subjected to in vivo acid attacks.
    Yu H, Jiang NW, Ye XY, Zheng HY, et al · · 2018 · cited 26× · PMID 29857075 · DOI 10.1016/j.jdent.2018.05.021

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Other trials of CPP-ACP

Trials testing the same drug.

Other Fujian Medical University trials

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