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

Gingivitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01578603
• Other study ID #: 15-2010
• Status: Completed
• Phase: Phase 4
• First received: April 9, 2012
• Last updated: May 9, 2012
• Start date: January 2011
• Est. completion date: May 2012

Study information

• Verified date: May 2012
• Source: Universidad de Antioquia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Colombia: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 16 Years to 34 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Dental Plaque
• Gingivitis
• Saliva Altered

Intervention

Dietary Supplement:
• xylitol
6 g/day, for a month, by chewing 2g three times daily after meals.
• casein phosphopeptide amorphous calcium phosphate complex
two pieces of the commercial presentation three times daily after meals

Locations

Country	Name	City	State
Colombia	Facultad de Odontología, Universidad de Antioquia	Medellín	Antioquia

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Antioquia

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Turesky index	dental plaque assessment	a month	No
Secondary	Gingival index	gingival inflammation	a month	No
Secondary	salivary pH		a month	No
Secondary	Streptococcus mutans	number of Streptococcus mutans in saliva	a month	No
Secondary	Ca levels	levels of calcium in saliva	a month	No
Secondary	facultative microorganisms	number of facultative microorganisms in saliva	a month	No
Secondary	Lactobacillus	levels of Lactobacillus spp. in saliva	a month	No
Secondary	phosphate levels	inorganic phosphate leves in saliva	a month	No
Secondary	BOP index	bleeding on probing	a month	No