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

NCT02310308 | Unknown DMC

• 1 other identifier: 1083/L
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 2

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.

Conditions

Dental Caries

Keywords

Xylitol; Magnolia; chewing gum

Outcome Measures

Primary Outcomes (1)

• International Caries Detection and Assessment System (ICDAS) increment

  cumulative D2 or Filled Surface (D2 FS) increment (root and coronal surfaces combined).

  24 months

Secondary Outcomes (2)

• Salivary mutants streptococci and lactobacilli counts

  6-12-24 months

• Modification of plaque pH

  6-12-24 months

Study Arms (3)

xylitol chewing gum

ACTIVE COMPARATOR

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

Xylitol-magnolia chewing gum

EXPERIMENTAL

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

Control chewing gum

PLACEBO COMPARATOR

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

Interventions

Chewing gum administration DIETARY_SUPPLEMENT

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.

Control chewing gum; Xylitol-magnolia chewing gum; xylitol chewing gum

Eligibility Criteria

• Age: 30 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Università degli Studi di Sassari: lead

Study Sites (2)

Department of Surgery, Microsurgery and Medicine Sciences University of Sassari

Sassari, Sardinia, I-07100, Italy

Location

WHO CC University of Milan

Milan, I-20121, Italy

Location

Related Publications (1)

• Cocco F, Carta G, Cagetti MG, Strohmenger L, Lingstrom P, Campus G. The caries preventive effect of 1-year use of low-dose xylitol chewing gum. A randomized placebo-controlled clinical trial in high-caries-risk adults. Clin Oral Investig. 2017 Dec;21(9):2733-2740. doi: 10.1007/s00784-017-2075-5. Epub 2017 Mar 16.

  PMID: 28303470 DERIVED

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor in Community Dentistry

Study Record Dates

• First Submitted: November 24, 2014
• First Posted: December 8, 2014
• Study Start: April 1, 2012
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2015
• Last Updated: December 8, 2014

Record last verified: 2014-12

Locations

IT (2)