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Effect of a Sugar-Free Chewing Gum Containing Magnolia Bark Extract on Caries Lesions in Healthy Adult Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02310308
Recruitment Status : Unknown
Verified December 2014 by Guglielmo Campus, Università degli Studi di Sassari.
Recruitment status was:  Active, not recruiting
First Posted : December 8, 2014
Last Update Posted : December 8, 2014
Sponsor:
Information provided by (Responsible Party):
Guglielmo Campus, Università degli Studi di Sassari

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 result of that double-blind randomized controlled interventional trial will be that chewing gum containing MBE was more effective in reducing plaque acidogenicity, salivary mutans streptococci concentration and gingival bleeding compared to a xylitol and sugar-free chewing gum.

Condition or disease Intervention/treatment Phase
Dental Caries Dietary Supplement: Chewing gum administration Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 480 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of a Sugar-free Chewing Gum Containing Magnolia Bark Extract on the Development of Caries Lesions in Healthy Adult Volunteers: a Randomized Controlled Intervention Trial
Study Start Date : April 2012
Actual Primary Completion Date : November 2014
Estimated Study Completion Date : November 2015

Arm Intervention/treatment
Active Comparator: xylitol chewing gum
Intervention chewing gum administration Each subject will be instructed to chew 1 or 2 pellets for 5 min 3 times a day (2 in the morning, 2 after the midday meal and 1 in the afternoon). Thus, the total daily intake of magnolol and honokiol in MX group will be 11.9 mg/day. The daily use of the two different chewing gums will be carried out for 12 months.
Dietary Supplement: Chewing gum administration
Intervention chewing gum Each subject will be instructed to chew 1 or 2 pellets for 5 min 3 times a day (2 in the morning, 2 after the midday meal and 1 in the afternoon). Thus, the total daily intake of magnolol and honokiol in MX group will be 11.9 mg/day. The daily use of the two different chewing gums will be carried out for 12 months.

Experimental: Xylitol-magnolia chewing gum
Intervention chewing gum administration Each subject will be instructed to chew 1 or 2 pellets for 5 min 3 times a day (2 in the morning, 2 after the midday meal and 1 in the afternoon). Thus, the total daily intake of magnolol and honokiol in MX group will be 11.9 mg/day. The daily use of the two different chewing gums will be carried out for 12 months.
Dietary Supplement: Chewing gum administration
Intervention chewing gum Each subject will be instructed to chew 1 or 2 pellets for 5 min 3 times a day (2 in the morning, 2 after the midday meal and 1 in the afternoon). Thus, the total daily intake of magnolol and honokiol in MX group will be 11.9 mg/day. The daily use of the two different chewing gums will be carried out for 12 months.

Placebo Comparator: Control chewing gum
Intervention chewing gum Each subject will be instructed to chew 1 or 2 pellets for 5 min 3 times a day (2 in the morning, 2 after the midday meal and 1 in the afternoon). Thus, the total daily intake of magnolol and honokiol in MX group will be 11.9 mg/day. The daily use of the two different chewing gums will be carried out for 12 months.
Dietary Supplement: Chewing gum administration
Intervention chewing gum Each subject will be instructed to chew 1 or 2 pellets for 5 min 3 times a day (2 in the morning, 2 after the midday meal and 1 in the afternoon). Thus, the total daily intake of magnolol and honokiol in MX group will be 11.9 mg/day. The daily use of the two different chewing gums will be carried out for 12 months.




Primary Outcome Measures :
  1. International Caries Detection and Assessment System (ICDAS) increment [ Time Frame: 24 months ]
    cumulative D2 or Filled Surface (D2 FS) increment (root and coronal surfaces combined).


Secondary Outcome Measures :
  1. Salivary mutants streptococci and lactobacilli counts [ Time Frame: 6-12-24 months ]
    Mutans streptococci and lactobacilli counts in saliva were assessed

  2. Modification of plaque pH [ Time Frame: 6-12-24 months ]
    and categorized using the dip-slide technique Interproximal-plaque pH of each subject was evaluated using pH indicator strips, Assessment of plaque pH value in the range of 4.0-7.0.



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Ages Eligible for Study:   30 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

The inclusion criteria for the recruitment of subjects are as follows:

  1. Age 30-45
  2. Presence of a minimum of 12 natural teeth
  3. At least one surface cavitated caries lesion, but no more than three
  4. Mutans streptococci and Lactobacilli >105 CFU/ml saliva
  5. Systemically healthy as assessed by a medical questionnaire
  6. No use of antibiotics or participation in a clinical study in the previous 30 days
  7. No allergy to any of the ingredients of the study products
  8. No orthodontic banding or removable prosthesis
  9. Moderate gingivitis, no current periodontitis (no sites of probing pocket depth ≥5 mm or attachment loss of ≥2 mm, apart from gingival recession).
  10. Absence of dysfunction of temporo-mandibular joint.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02310308


Locations
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Italy
Department of Surgery, Microsurgery and Medicine Sciences University of Sassari
Sassari, Sardinia, Italy, I-07100
WHO CC University of Milan
Milan, Italy, I-20121
Sponsors and Collaborators
Università degli Studi di Sassari
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Guglielmo Campus, Associate Professor in Community Dentistry, Università degli Studi di Sassari
ClinicalTrials.gov Identifier: NCT02310308    
Other Study ID Numbers: 1083/L
First Posted: December 8, 2014    Key Record Dates
Last Update Posted: December 8, 2014
Last Verified: December 2014
Keywords provided by Guglielmo Campus, Università degli Studi di Sassari:
Xylitol
Magnolia
chewing gum
Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases