Text Size

Effects of Two Sugar Substituted Chewing Gums on Caries and Gingivitis Variables

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
María Cecilia Martínez-Pabón, Universidad de Antioquia
ClinicalTrials.gov Identifier:
NCT01578603
First received: April 9, 2012
Last updated: May 9, 2012
Last verified: May 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Dental Plaque
Saliva Altered
Gingivitis
 Dietary Supplement: xylitol
Dietary Supplement: casein phosphopeptide amorphous calcium phosphate complex
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of Two Sugar Substituted Chewing Gums Plus Tooth Brushing on Different Caries and Gingivitis Related Variables: a Double Blind, Randomized Controlled Clinical Trial

Resource links provided by NLM:

MedlinePlus related topics: Calcium Tooth Decay
U.S. FDA Resources

Further study details as provided by Universidad de Antioquia:

Primary Outcome Measures:
  • Turesky index [ Time Frame: a month ] [ Designated as safety issue: No ]
    dental plaque assessment


Secondary Outcome Measures:
  • Gingival index [ Time Frame: a month ] [ Designated as safety issue: No ]
    gingival inflammation

  • salivary pH [ Time Frame: a month ] [ Designated as safety issue: No ]
  • Streptococcus mutans [ Time Frame: a month ] [ Designated as safety issue: No ]
    number of Streptococcus mutans in saliva

  • Ca levels [ Time Frame: a month ] [ Designated as safety issue: No ]
    levels of calcium in saliva

  • facultative microorganisms [ Time Frame: a month ] [ Designated as safety issue: No ]
    number of facultative microorganisms in saliva

  • Lactobacillus [ Time Frame: a month ] [ Designated as safety issue: No ]
    levels of Lactobacillus spp. in saliva

  • phosphate levels [ Time Frame: a month ] [ Designated as safety issue: No ]
    inorganic phosphate leves in saliva

  • BOP index [ Time Frame: a month ] [ Designated as safety issue: No ]
    bleeding on probing


Enrollment: 130
Study Start Date: January 2011
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: sugar substituted chewing gum A Dietary Supplement: casein phosphopeptide amorphous calcium phosphate complex
two pieces of the commercial presentation three times daily after meals
Other Name: CPP-ACP complex
Experimental: Sugar substituted chewing gum B Dietary Supplement: xylitol
6 g/day, for a month, by chewing 2g three times daily after meals.
Other Name: sugar alcohol

Detailed Description:

The purpose of this paper is to compare the effect of daily consumption of two sugar-free chewing gum, one with Recaldent and one with Xylitol, added to traditional hygiene (brushing, fluoridated toothpaste and dental floss), in clinical features such as the accumulation of plaque and gingival inflammation, microbiological characteristics of saliva as the counts of cariogenic microorganisms and facultative anaerobes, and some physicochemical properties of saliva such as pH and concentrations of calcium and inorganic phosphate.

To this there was a general call among dental students at the University of Antioquia and those who expressed their intention to participate voluntarily with informed consent, were examined clinically and randomly assigned to one of the study groups (Recaldent or Xylitol) or the control group.

After a month of baseline examination and the daily use of the same instruments of oral hygiene and chewing of 6 pellets of each chewing gum (in the case of study groups), all variables are re-examined.

  Eligibility

Ages Eligible for Study:   16 Years to 34 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • systemically healthy
  • dental student

Exclusion Criteria:

  • less than 26 teeth in mouth
  • use of orthodontic appliances
  • use of antibiotics the last 3 months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01578603

Locations
Colombia
Facultad de Odontología, Universidad de Antioquia
Medellín, Antioquia, Colombia
Sponsors and Collaborators
Universidad de Antioquia
Investigators
Study Director: Maria C Martínez-Pabón, MsC Microb Universidad de Antioquia
  More Information

No publications provided

Responsible Party: María Cecilia Martínez-Pabón, Profesora Asociada, Universidad de Antioquia
ClinicalTrials.gov Identifier: NCT01578603     History of Changes
Other Study ID Numbers: 15-2010
Study First Received: April 9, 2012
Last Updated: May 9, 2012
Health Authority: Colombia: Institutional Review Board

Keywords provided by Universidad de Antioquia:
prevention & control
Xylitol
casein phosphopeptide amorphous calcium phosphate complex
Streptococcus mutans
 saliva
dental plaque
gingivitis

Additional relevant MeSH terms:
Dental Plaque
Gingivitis
Dental Deposits
Tooth Diseases
Stomatognathic Diseases
Gingival Diseases
 Periodontal Diseases
Mouth Diseases
Caseins
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013