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

Sponsor

Universidad de Antioquia (Other)

Overall Status

Completed

CT.gov ID

NCT01578603

Collaborator

(none)

130

Enrollment

Location

Arms

Duration (Months)

8.1

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

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 :

Jan 1, 2011

Actual Primary Completion Date :

May 1, 2012

Actual Study Completion Date :

May 1, 2012

Arms and Interventions

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 Names: 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 Names: sugar alcohol

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 Names:

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 Names:

sugar alcohol

Outcome Measures

Primary Outcome Measures

Turesky index [a month]
dental plaque assessment

Secondary Outcome Measures

Gingival index [a month]
gingival inflammation
salivary pH [a month]
Streptococcus mutans [a month]
number of Streptococcus mutans in saliva
Ca levels [a month]
levels of calcium in saliva
facultative microorganisms [a month]
number of facultative microorganisms in saliva
Lactobacillus [a month]
levels of Lactobacillus spp. in saliva
phosphate levels [a month]
inorganic phosphate leves in saliva
BOP index [a month]
bleeding on probing