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

Sponsor

Fujian Medical University (Other)

Overall Status

Completed

CT.gov ID

NCT03426150

Collaborator

(none)

Enrollment

Arms

25.4

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dental Erosion	Drug: CPP-ACP Drug: Placebos	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

12 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Participant)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Dec 25, 2015

Actual Primary Completion Date :

Oct 25, 2017

Actual Study Completion Date :

Feb 5, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CPP-ACP Tooth mousse (GC, Japan) application on the specimen surface for 3 min.	Drug: CPP-ACP The surfaces of specimens were pretreated with CPP-ACP for 3 min
Placebo Comparator: Deionized water Deionized water application on the specimen surface for 3 min	Drug: Placebos The surfaces of specimens were pretreated with deionized water for 3 min

Arm

Intervention/Treatment

Experimental: CPP-ACP

Tooth mousse (GC, Japan) application on the specimen surface for 3 min.

Drug: CPP-ACP

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

Placebo Comparator: Deionized water

Deionized water application on the specimen surface for 3 min

Drug: Placebos

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

Outcome Measures

Primary Outcome Measures

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.
Surface microhardness [7 days]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Fujian Medical University

Investigators

Principal Investigator: Hao Yu, DDS, PhD, School and Hospital of Stomatology, Fujian Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hao Yu, Department Head, Fujian Medical University

ClinicalTrials.gov Identifier:

NCT03426150

Other Study ID Numbers:

20151225

First Posted:

Feb 8, 2018

Last Update Posted:

Feb 8, 2018

Last Verified:

Feb 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Tooth Erosion

Study Results

No Results Posted as of Feb 8, 2018