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

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.

Study Overview

• Status: Completed
• Conditions: Gingivitis; Dental Plaque; Saliva Altered
• Intervention / Treatment: Dietary supplement: casein phosphopeptide amorphous calcium phosphate complex; Dietary supplement: xylitol

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 Type: Interventional
• Enrollment (Actual): 130
• Phase: Phase 4

Contacts and Locations

Study Locations

• Colombia
  • Antioquia
    • Medellín, Antioquia, Colombia
      • Facultad de Odontología, Universidad de Antioquia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 32 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Turesky index	dental plaque assessment	a month

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Universidad de Antioquia
• Investigators: Study Director: Maria C Martínez-Pabón, MsC Microb, Universidad de Antioquia

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: April 9, 2012
• First Submitted That Met QC Criteria: April 14, 2012
• First Posted (Estimate): April 17, 2012

Study Record Updates

• Last Update Posted (Estimate): May 10, 2012
• Last Update Submitted That Met QC Criteria: May 9, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: gingivitis; dental plaque; prevention & control; Xylitol; saliva; Streptococcus mutans; casein phosphopeptide amorphous calcium phosphate complex
• Additional Relevant MeSH Terms: Infections; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Tooth Diseases; Dental Deposits; Gingivitis; Dental Plaque; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Calcium-Regulating Hormones and Agents; Chelating Agents; Sequestering Agents; Calcium; Caseins
• Other Study ID Numbers: 15-2010