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

U

Universidad de Antioquia

Status and phase

Completed
Phase 4

Conditions

Dental Plaque
Gingivitis
Saliva Altered

Treatments

Dietary Supplement: casein phosphopeptide amorphous calcium phosphate complex
Dietary Supplement: xylitol

Study type

Interventional

Funder types

Other

Identifiers

NCT01578603
15-2010

Details and patient eligibility

About

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.

Full 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.

Enrollment

130 patients

Sex

All

Ages

16 to 34 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

130 participants in 2 patient groups

sugar substituted chewing gum A
Experimental group
Treatment:
Dietary Supplement: casein phosphopeptide amorphous calcium phosphate complex
Sugar substituted chewing gum B
Experimental group
Treatment:
Dietary Supplement: xylitol

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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