NCT01578603

Brief Summary

The purpose of this study is to determine the effect of three times a day mastication, during a follow-up period of 4 weeks, of two sugar-substituted chewing gums on various factors associated with dental caries and gingivitis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
130

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

1 active site

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

January 1, 2011

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 9, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 17, 2012

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

May 10, 2012

Status Verified

May 1, 2012

Enrollment Period

1.3 years

First QC Date

April 9, 2012

Last Update Submit

May 9, 2012

Conditions

Dental PlaqueSaliva AlteredGingivitis

Keywords

prevention & controlXylitolcasein phosphopeptide amorphous calcium phosphate complexStreptococcus mutanssalivadental plaquegingivitis

Outcome Measures

Primary Outcomes (1)

  • Turesky index

    dental plaque assessment

    a month

Secondary Outcomes (8)

  • Gingival index

    a month

  • salivary pH

    a month

  • Streptococcus mutans

    a month

  • Ca levels

    a month

  • facultative microorganisms

    a month

  • +3 more secondary outcomes

Study Arms (2)

sugar substituted chewing gum A

EXPERIMENTAL
Dietary Supplement: casein phosphopeptide amorphous calcium phosphate complex

Sugar substituted chewing gum B

EXPERIMENTAL
Dietary Supplement: xylitol

Interventions

xylitolDIETARY_SUPPLEMENT

6 g/day, for a month, by chewing 2g three times daily after meals.

Also known as: sugar alcohol
Sugar substituted chewing gum B
casein phosphopeptide amorphous calcium phosphate complexDIETARY_SUPPLEMENT

two pieces of the commercial presentation three times daily after meals

Also known as: CPP-ACP complex
sugar substituted chewing gum A

Eligibility Criteria

Age16 Years - 34 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • systemically healthy
  • dental student

You may not qualify if:

  • less than 26 teeth in mouth
  • use of orthodontic appliances
  • use of antibiotics the last 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Facultad de Odontología, Universidad de Antioquia

Medellín, Antioquia, Colombia

Location

MeSH Terms

Conditions

Dental PlaqueGingivitis

Interventions

XylitolSugar Alcohols

Condition Hierarchy (Ancestors)

Dental DepositsTooth DiseasesStomatognathic DiseasesInfectionsGingival DiseasesPeriodontal DiseasesMouth Diseases

Intervention Hierarchy (Ancestors)

AlcoholsOrganic ChemicalsCarbohydrates

Study Officials

  • Maria C Martínez-Pabón, MsC Microb

    Universidad de Antioquia

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Profesora Asociada

Study Record Dates

First Submitted

April 9, 2012

First Posted

April 17, 2012

Study Start

January 1, 2011

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

May 10, 2012

Record last verified: 2012-05

Locations

CO(1)