Status:
UNKNOWN
Effect of a Sugar-Free Chewing Gum Containing Magnolia Bark Extract on Caries Lesions in Healthy Adult Volunteers
Lead Sponsor:
Università degli Studi di Sassari
Conditions:
Dental Caries
Eligibility:
All Genders
30-45 years
Phase:
NA
Brief Summary
The effect of chewing gums containing MBE and xylitol on different variables related to caries and gingivitis in a sample of adult volunteers with a high risk for caries will be evaluated. The main re...
Detailed Description
Introduction Dental caries incidence in adults is similar to that in children and adolescents, but few caries preventive agents have been evaluated for effectiveness in adult populations. Magnolia ba...
Eligibility Criteria
Inclusion
- The inclusion criteria for the recruitment of subjects are as follows:
- Age 30-45
- Presence of a minimum of 12 natural teeth
- At least one surface cavitated caries lesion, but no more than three
- Mutans streptococci and Lactobacilli \>105 CFU/ml saliva
- Systemically healthy as assessed by a medical questionnaire
- No use of antibiotics or participation in a clinical study in the previous 30 days
- No allergy to any of the ingredients of the study products
- No orthodontic banding or removable prosthesis
- Moderate gingivitis, no current periodontitis (no sites of probing pocket depth ≥5 mm or attachment loss of ≥2 mm, apart from gingival recession).
- Absence of dysfunction of temporo-mandibular joint.
Exclusion
- Subjects with a history of GI problems and with systemic disease that interfered with the oral ecosystem were excluded. The caries criterion was designed to include participants who are at risk of forming new lesions.
- In addition, those participants who were already consuming more than three pieces of sugar-free chewing gum a day were excluded.
Key Trial Info
Start Date :
April 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2015
Estimated Enrollment :
480 Patients enrolled
Trial Details
Trial ID
NCT02310308
Start Date
April 1 2012
End Date
November 1 2015
Last Update
December 8 2014
Active Locations (2)
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1
Department of Surgery, Microsurgery and Medicine Sciences University of Sassari
Sassari, Sardinia, Italy, I-07100
2
WHO CC University of Milan
Milan, Italy, I-20121