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Completed

NCT Number: NCT01578603

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

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.

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Key information

Age range

16 year–34 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Facultad de Odontología, Universidad de Antioquia

Medellín, Antioquia, Colombia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Xylitol

Dietary Supplement

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

Other names: sugar alcohol

casein phosphopeptide amorphous calcium phosphate complex

Dietary Supplement

two pieces of the commercial presentation three times daily after meals

Other names: CPP-ACP complex

Primary outcomes

  1. Turesky index

    Time frame: a month

    dental plaque assessment

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Universidad de Antioquia

Other

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Apr 17, 2012
Registry last updated
May 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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