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

In Situ Effect of Casein Phosphopeptide--amorphous Calcium Phosphate on the Surface Microhardness of Human Enamel Subjected to in Vivo Acid Attacks

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03426150

Enrollment

Registered

2018-02-08

Start date

2015-12-25

Completion date

2018-02-05

Last updated

2018-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Erosion

Brief summary

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.

Interventions

DRUGCPP-ACP

The surfaces of specimens were pretreated with CPP-ACP for 3 min

DRUGPlacebos

The surfaces of specimens were pretreated with deionized water for 3 min

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

Inclusion criteria

* 18 to 60 years of age and in good general health * Dental erosion and wear degree is 0-1

Exclusion criteria

* Systemic diseases or oral mucosal disorders * Current orthodontic treatment * Pregnancy * Known allergies to the experimental drink * Had been given drugs which lead to dry oral more regularly within half a year

Design outcomes

Primary

Measure	Time frame	Description
Surface microhardness	baseline	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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026