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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01578603
Recruitment Status : Completed
First Posted : April 17, 2012
Last Update Posted : May 10, 2012
Information provided by (Responsible Party):
María Cecilia Martínez-Pabón, Universidad de Antioquia

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.

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

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : January 2011
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Casein

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Turesky index [ Time Frame: a month ]
    dental plaque assessment

Secondary Outcome Measures :
  1. Gingival index [ Time Frame: a month ]
    gingival inflammation

  2. salivary pH [ Time Frame: a month ]
  3. Streptococcus mutans [ Time Frame: a month ]
    number of Streptococcus mutans in saliva

  4. Ca levels [ Time Frame: a month ]
    levels of calcium in saliva

  5. facultative microorganisms [ Time Frame: a month ]
    number of facultative microorganisms in saliva

  6. Lactobacillus [ Time Frame: a month ]
    levels of Lactobacillus spp. in saliva

  7. phosphate levels [ Time Frame: a month ]
    inorganic phosphate leves in saliva

  8. BOP index [ Time Frame: a month ]
    bleeding on probing

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Ages Eligible for Study:   16 Years to 34 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01578603

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

Responsible Party: María Cecilia Martínez-Pabón, Profesora Asociada, Universidad de Antioquia Identifier: NCT01578603     History of Changes
Other Study ID Numbers: 15-2010
First Posted: April 17, 2012    Key Record Dates
Last Update Posted: May 10, 2012
Last Verified: May 2012

Keywords provided by María Cecilia Martínez-Pabón, Universidad de Antioquia:
prevention & control
casein phosphopeptide amorphous calcium phosphate complex
Streptococcus mutans
dental plaque

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