Skip to content

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

Effects of Two Sugar Substituted Chewing Gums Plus Tooth Brushing on Different Caries and Gingivitis Related Variables: a Double Blind, Randomized Controlled Clinical Trial

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01578603
Enrollment
130
Registered
2012-04-17
Start date
2011-01-31
Completion date
2012-05-31
Last updated
2012-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Plaque, Gingivitis, Saliva Altered

Keywords

prevention & control, Xylitol, casein phosphopeptide amorphous calcium phosphate complex, Streptococcus mutans, saliva, dental plaque, gingivitis

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.

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.

Interventions

DIETARY_SUPPLEMENTxylitol

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

DIETARY_SUPPLEMENTcasein phosphopeptide amorphous calcium phosphate complex

two pieces of the commercial presentation three times daily after meals

Sponsors

Universidad de Antioquia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
16 Years to 34 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Turesky indexa monthdental plaque assessment

Secondary

MeasureTime frameDescription
salivary pHa month
Streptococcus mutansa monthnumber of Streptococcus mutans in saliva
Ca levelsa monthlevels of calcium in saliva
Gingival indexa monthgingival inflammation
Lactobacillusa monthlevels of Lactobacillus spp. in saliva
phosphate levelsa monthinorganic phosphate leves in saliva
BOP indexa monthbleeding on probing
facultative microorganismsa monthnumber of facultative microorganisms in saliva

Countries

Colombia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026