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

Phase 4

Completed

• Conditions: Dental Plaque; Saliva Altered; Gingivitis
• Interventions: Dietary Supplement: casein phosphopeptide amorphous calcium phosphate complex; Dietary Supplement: xylitol

• Registration Number: NCT01578603
• Lead Sponsor: Universidad de Antioquia

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.

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2012-04-09
• Study First Submitted QC: 2012-04-14
• Study First Posted: 2012-04-17
• Status Verified: 2012-05
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Last Update Submitted: 2012-05-09
• Last Update Posted: 2012-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sugar substituted chewing gum A	casein phosphopeptide amorphous calcium phosphate complex	-
Sugar substituted chewing gum B	xylitol	-

Primary Outcome Measures

Name	Time	Method
Turesky index	a month	dental plaque assessment

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Facultad de Odontología, Universidad de Antioquia; 🇨🇴 Medellín, Antioquia, Colombia