NCT01377493

Brief Summary

There were no differences in the degree of enamel remineralization of subsurface lesions among the chewing gums containing or not containing POs-Ca and fluoride.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Dec 2009

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

June 17, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 21, 2011

Completed
Last Updated

June 21, 2011

Status Verified

June 1, 2011

Enrollment Period

2 months

First QC Date

June 17, 2011

Last Update Submit

June 20, 2011

Conditions

Enamel Subsurface Lesion

Keywords

chewing-gumenamel subsurface lesioncalcium additivesfluoridein situ

Outcome Measures

Primary Outcomes (1)

  • Mineral content of enamel

    Mineral content of bovine enamel blocks inserted into the subject mouth during chewing of the gums was assessed.

    2 weeks

Study Arms (3)

placebo

PLACEBO COMPARATOR
Dietary Supplement: chewing gum

POs-Ca

ACTIVE COMPARATOR
Dietary Supplement: chewing gum

POs-Ca+F

ACTIVE COMPARATOR
Dietary Supplement: chewing gum

Interventions

chewing gumDIETARY_SUPPLEMENT

chewing gum containing no active ingredients, or Ca-P bioavailable ions, or Ca-P and F bioavailable ions

POs-CaPOs-Ca+Fplacebo

Eligibility Criteria

Age20 Years - 31 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy adult subjects
  • More than 22 permanent teeth

You may not qualify if:

  • Alcohol addiction
  • Smoking
  • Active caries
  • Periodontal pockets
  • Low-saliva flow (less than 0.3ml/min)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Kitasako Y, Sadr A, Hamba H, Ikeda M, Tagami J. Gum containing calcium fluoride reinforces enamel subsurface lesions in situ. J Dent Res. 2012 Apr;91(4):370-5. doi: 10.1177/0022034512439716. Epub 2012 Feb 15.

    PMID: 22337700DERIVED

  • Kitasako Y, Tanaka M, Sadr A, Hamba H, Ikeda M, Tagami J. Effects of a chewing gum containing phosphoryl oligosaccharides of calcium (POs-Ca) and fluoride on remineralization and crystallization of enamel subsurface lesions in situ. J Dent. 2011 Nov;39(11):771-9. doi: 10.1016/j.jdent.2011.08.009. Epub 2011 Aug 19.

    PMID: 21875640DERIVED

MeSH Terms

Interventions

Chewing Gum

Intervention Hierarchy (Ancestors)

Plant GumsBiopolymersPolymersMacromolecular SubstancesPolysaccharidesCarbohydratesPlant ExudatesBiological ProductsComplex MixturesCandyFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 17, 2011

First Posted

June 21, 2011

Study Start

December 1, 2009

Primary Completion

February 1, 2010

Study Completion

June 1, 2011

Last Updated

June 21, 2011

Record last verified: 2011-06