Functional Chewing Gum in Reduction of Gingival Inflammation

NCT03237624 | Completed DMC

• 1 other identifier: HP-00073354
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this prospective randomized 3-month double-blinded single center study is to determine whether a chewing gum device with food additive chitosan, will aid in reducing gingival inflammation by supplementing traditional tooth brushing and flossing measures. Patients with mild to moderate gingivitis will be identified and enrolled in this investigation. All enrolled subjects will receive baseline oral hygiene brushing instructions and a baseline clinical examination of the gingiva. The test group will utilize the test chewing gum three times a day for a minimum 20-30 minutes duration; the control group will receive a placebo gum and use it in a similar manner. We will examine whether daily use of a functional chewing gum enhances improvements to brushing and flossing.

Conditions

Gingivitis

Keywords

gingivitis

Outcome Measures

Primary Outcomes (1)

• Gum inflammation change

  Measure the color of gingiva - use Gingiva Index

  Change in color of gingiva from baseline to 12 weeks

Secondary Outcomes (1)

• Plaque levels (on teeth) change

  Change in plaque level from baseline to 12 weeks

Study Arms (2)

Functional chewing gum

EXPERIMENTAL

Subjects given as intervention functional chewing gum device to supplement oral hygiene practices. Functional gum contains chitosan which is a food additive or generally recognized as safe food product. Individuals will use this gum 20 to 30 minutes three times per day. Subjects will brush and floss normally twice a day.

Device: Functional Chitosan Chewing Gum; Behavioral: Oral hygiene measures

Control chewing gum

PLACEBO COMPARATOR

Subjects given control gum to supplement oral hygiene practices. Placebo gum does not contain any active ingredients. Individuals will use this gum 20 to 30 minutes three times per day. Subjects will brush and floss normally twice a day.

Device: Control Chewing Gum; Behavioral: Oral hygiene measures

Interventions

Functional Chitosan Chewing Gum DEVICE

Chitosan and chitosan-related preparations have been shown to have some antimicrobial properties, possibly in the disruption of bacterial colonization. It is thought that as a component of a functional chewing gum this will supplement in the removal of daily build up of dental plaque on tooth surfaces.

Functional chewing gum

Control Chewing Gum DEVICE

Control chewing gum device does not have food additive chitosan in its composition.

Control chewing gum

Oral hygiene measures BEHAVIORAL

Patients will be given instructions on how to brush and floss routinely (twice per day)

Control chewing gum; Functional chewing gum

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mild-moderate gingivitis
• Minimum of 20 natural teeth

You may not qualify if:

• Significant alveolar bone loss as evidenced by Bite-wings (\>3.0 mm cementoenamel junction to bone)
• Requirement for antibiotic pre-medication prior to dental procedures
• Systemic antibiotic use in past 14 days to current.
• Use of oral contraceptives
• Use of anti-inflammatory (NSAIDs) or in past 14 days.
• Use of anticoagulant therapy or in past 14 days.
• Poorly controlled diabetes (HbA1c \> 7.9%)\*
• Smoking
• Pregnancy
• Use of any oral rinses such as, but not limited to chlorhexidine, essential oils, cetylpyridinium chloride during the study.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland School of Dentistry

Baltimore, Maryland, 21201, United States

Location

Related Publications (4)

• Kaur S, Dhillon GS. The versatile biopolymer chitosan: potential sources, evaluation of extraction methods and applications. Crit Rev Microbiol. 2014 May;40(2):155-75. doi: 10.3109/1040841X.2013.770385. Epub 2013 Mar 14.

  PMID: 23488873 BACKGROUND

• Machul A, Mikolajczyk D, Regiel-Futyra A, Heczko PB, Strus M, Arruebo M, Stochel G, Kyziol A. Study on inhibitory activity of chitosan-based materials against biofilm producing Pseudomonas aeruginosa strains. J Biomater Appl. 2015 Sep;30(3):269-78. doi: 10.1177/0885328215578781. Epub 2015 Apr 8.

  PMID: 25855683 BACKGROUND

• Li Y, Lee S, Hujoel P, Su M, Zhang W, Kim J, Zhang YP, DeVizio W. Prevalence and severity of gingivitis in American adults. Am J Dent. 2010 Feb;23(1):9-13.

  PMID: 20437720 BACKGROUND

• Simons D, Beighton D, Kidd EA, Collier FI. The effect of xylitol and chlorhexidine acetate/xylitol chewing gums on plaque accumulation and gingival inflammation. J Clin Periodontol. 1999 Jun;26(6):388-91. doi: 10.1034/j.1600-051x.1999.260609.x.

  PMID: 10382579 BACKGROUND

MeSH Terms

Conditions

Gingivitis

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Harlan Shiau, DDS

  UMSOD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: July 31, 2017
• First Posted: August 2, 2017
• Study Start: January 31, 2018
• Primary Completion: January 31, 2020
• Study Completion: January 31, 2020
• Last Updated: November 26, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)