Effect of an active compound containing gum on dental plaque formation on a 4-day accumulation model
Investigation of Gum Containing Investigational Ingredient on Dental Plaque Formation
Ana Gossweiler, DDS
Primary Investigator
Brief description of study
The primary endpoint of this study is to evaluate the efficacy of MIIP-E2 in inhibiting plaque formation in healthy patients in the absence of tooth brushing using a 4-day plaque accumulation model. The secondary endpoint is to evaluate whether MIIP-E2-containing gum alters the oral microflora.
Detailed description of study
This will be a single-blind, single-center, 3-way crossover, randomized controlled clinical trial with 3 treatment periods utilizing 32 subjects. (Fig 1) Each treatment period will be 4 days (96 hours +/—3 hours) in accordance with the plaque accumulation model [25] using one of the following treatment groups: an active compound MIIP-E2 gum (experimental regimen), an inactive compound gum (negative control regimen), and a no-gum (control regimen) . Each subject will be assigned to one of the following three treatment regimen sequences:
1. Control regimen followed by experimental regimen, followed by a negative control regimen, or
2. Experimental regimen followed by negative control regimen, followed by control regimen or
3. Negative control regimen followed by control regimen, followed by an experimental regimen
Subjects will be asked to refrain from oral hygiene (OH) procedures and chewing gum 12 hours (+/- 2 hours) and from eating or drinking (except for water) 2 hours prior to the screening visit. During the 4-day study treatment periods, subjects will also be asked to refrain from oral hygiene practices or any elective dental treatment. Subjects can resume their regular oral hygiene procedures during the wash-out periods of approximately 10 days.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Healthy
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Age: 18 years - 65 years
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Gender: All
Inclusion Criteria:
• Adult subjects between 18 and 65 years old
• Willing to read and sign the IRB-approved informed consent.
• Healthy, as determined by pertinent medical history at the study dentist's discretion.
• A minimum of 20 natural teeth (excluding third molars) with at least two scorable surfaces per tooth (teeth with full crowns, large/extensive restorations on the interproximal areas, and orthodontic bands will not be included in the tooth count)
• PLI of 2 or greater (Based on the Turesky modification of the Quigley and Hein Plaque Index) calculation based on a whole mouth plaque score.
• Willing to comply with the study procedures.
Exclusion Criteria:
• Presence of any acute or chronic condition, organ system disease, or medication that, in the principal investigator's opinion, could compromise the subjects’ ability to participate in the study.
• Gross oral pathologies, including caries, calculus, or soft tissue conditions that show evidence of chronic neglect.
• Evidence of acute periodontal conditions or periodontitis with pockets greater than 5 mm on more than one site
• Use of antibiotics 30 days prior to or during the study
• Requiring the need for antibiotic premedication prior to dental procedures
• Sensitivity to bovine products (lactoferrin) or any of the listed inactive ingredients
• Orthodontic appliances or any removable, except lingual bar retainers
• Self-reported pregnant, wanting to get pregnant, or breast-feeding female,
• Self-reported allergy to disclosing solution ingredients (red dye #28)
• Acute Temporomandibular Disorders (TMD)
• Subject who has participated in other studies (including non-medicinal studies) involving product(s) within 30 days before study screening.
• Subject who has previously been randomized in this study
• An employee of the study site directly involved with the study
This study investigates the effect of an investigational gum containing an active compound on dental plaque formation. Dental plaque is a sticky film of bacteria that forms on teeth and can lead to cavities and gum disease if not removed. The purpose of this study is to evaluate how well this gum inhibits plaque formation in healthy adults who do not brush their teeth during the study period.
Participants will be involved in a single-blind, randomized controlled trial with three treatment periods. These periods include using the investigational gum, an inactive gum, and no gum at all. Participants will refrain from oral hygiene practices during the treatment periods to assess the gum's effectiveness. The study will also explore whether the gum changes the oral microflora, which refers to the different types of bacteria present in the mouth.
- Who can participate: Adults aged 18 to 65 years who are healthy, have at least 20 natural teeth, and a plaque index score of 2 or greater are eligible. Participants must be willing to sign informed consent and comply with study procedures.
- Study details: Participants will be asked to use the investigational gum, an inactive gum, or no gum in different sequences during the study. They must refrain from oral hygiene practices during treatment periods, but can resume normal routines in wash-out periods. The inactive gum is a placebo, meaning it looks like the investigational gum but does not contain any active ingredients.
- Study timelines: The study will last 4 days for each treatment period, with wash-out periods of approximately 10 days.
