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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Dental Plaque, Saliva Altered, Gingivitis

Intervention / Treatment
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* Dietary Supplement: xylitol
* Dietary Supplement: casein phosphopeptide amorphous calcium phosphate complex


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 34 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sugar substituted chewing gum A<br> | Dietary Supplement: casein phosphopeptide amorphous calcium phosphate complex<br>* two pieces of the commercial presentation three times daily after meals<br>* Other names: CPP-ACP complex;|
| Experimental: Sugar substituted chewing gum B<br> | Dietary Supplement: xylitol<br>* 6 g/day, for a month, by chewing 2g three times daily after meals.<br>* Other names: sugar alcohol;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Streptococcus mutans, dental plaque, gingivitis, prevention & control, Xylitol, casein phosphopeptide amorphous calcium phosphate complex, saliva