Functional Chewing Gum in Reduction of Gingival Inflammation

Study Overview
=================
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.

Detailed Description
-----------------
Periodontal disease remains a prevalent and preventable disease in man. Plaque bacterial biofilm remains the primary etiologic agent of disease; colonization of non-shedding tooth surfaces greatly contributes to initiation and progression of gingivitis, for example. Although there are currently available chemotherapeutic agents to supplement daily oral hygiene measures, one continuous issue is patient compliance. Chewing gum represents a unique delivery device for not only drugs and other agents, but food additives that might aid in reducing bacteria plaque colonization on tooth surfaces. For example, chitosan and chitosan-related food additive preparations have been shown to have some antimicrobial-like properties, possibly in the disruption of bacterial colonization (not -cidal). NOTE: ALL INGREDIENTS of the test chewing gum, and the placebo chewing gum, are generally regarded as safe (GRAS label by the Food and Drug Administration), as they are common food components. For example, chitosan is listed in the GRAS database (https://www.accessdata.fda.gov/scripts/fdcc/?set=SCOGS). See item GRN No. 397. This study aims to determine whether adjunctive use of functional chewing gum will improve gingival inflammation status-retaining clinical gains initiated by professional tooth cleaning and at home brushing over a 12 week period in gingivitis patients. Eligibility criteria and outcome measures are described in the next section.

Official Title
-----------------
Use of a Functional Chewing Gum in Reduction of Gingival Inflammation

Conditions
-----------------
Gingivitis

Intervention / Treatment
-----------------
* Device: Functional Chitosan Chewing Gum
* Device: Control Chewing Gum
* Behavioral: Oral hygiene measures


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mild-moderate gingivitis Minimum of 20 natural teeth Exclusion Criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Functional chewing gum<br>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<br>* 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.<br>Behavioral: Oral hygiene measures<br>* Patients will be given instructions on how to brush and floss routinely (twice per day)<br>|
| Placebo Comparator: Control chewing gum<br>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<br>* Control chewing gum device does not have food additive chitosan in its composition.<br>Behavioral: Oral hygiene measures<br>* Patients will be given instructions on how to brush and floss routinely (twice per day)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gum inflammation change | Measure the color of gingiva - use Gingiva Index | Change in color of gingiva from baseline to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plaque levels (on teeth) change | Measure plaque using Plaque Index | Change in plaque level from baseline to 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gingivitis