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Next Science Antimicrobial Mouth Rinse Study

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: NCT03154021
Recruitment Status : Completed
First Posted : May 15, 2017
Last Update Posted : February 18, 2019
Sponsor:
Collaborator:
Next Science LLC
Information provided by (Responsible Party):
University of Florida

Brief Summary:
To assess the effect of a test antimicrobial oral rinse from Next Science on the prevention of oral biofilm formation and thereby preventing gingivitis by monitoring the oral microbial flora and measuring gingival inflammation and bleeding.

Condition or disease Intervention/treatment Phase
Gingivitis Dental Plaque Combination Product: Next Science OTC Oral Rinse with Essential Oils Combination Product: OTC Oral Rinse Control Phase 1

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: One half of subjects will be given test product other half will be given placebo.
Masking: Double (Participant, Investigator)
Masking Description: The identity of the experimental oral rinse and its placebo will be disguised. Test and control kit boxes will contain toothpaste, a toothbrush, dose cups and a timer. The kit boxes will be labeled with a unique kit number representing the test product or placebo known only to the manufacturer. Kit box labels will also contain the study number, emergency phone number, distributor name/address, appropriate caution statements, content statement and other information as required by internal regulations and clinical SOPs. Kit box content statement will be worded to maintain the study blind.
Primary Purpose: Prevention
Official Title: Clinical Effectiveness of Next Science Oral Rinse in Controlling Plaques and Gingival Inflammation
Actual Study Start Date : August 28, 2017
Actual Primary Completion Date : March 8, 2018
Actual Study Completion Date : May 15, 2018

Arm Intervention/treatment
Experimental: Gingivitis Test
All subjects will have oral examination, dental cleaning, plaque samples taken, given Colgate Total Toothpaste, Oral B Manual Toothbrush and Next Science Over the Counter (OTC) Oral Rinse with Essential Oils.
Combination Product: Next Science OTC Oral Rinse with Essential Oils
This group will receive Next Science Oral Rinse with Essential Oils and the other half will be give OTC Oral Rinse Control

Placebo Comparator: Gingivitis Placebo
All subjects will have oral examination, dental cleaning, plaque samples taken, given Colgate Total Toothpaste, Oral B Manual Toothbrush and OTC Oral Rinse Control.
Combination Product: OTC Oral Rinse Control
This group will receive OTC Oral Rinse Control




Primary Outcome Measures :
  1. Oral Exam to see if there are any changes in pocket depths at two weeks, six weeks and twelve weeks [ Time Frame: Baseline, six weeks and twelve weeks. ]
    Complete oral exam with charting of pocket depths

  2. Gingival Index to see if there are any changes in gingival index at two weeks, six weeks and twelve weeks. [ Time Frame: Baseline, six weeks and twelve weeks. ]
    Gingival Index using Loe and Silness Gingival index

  3. Plaque index to see if there are any changes in plaque scores at two weeks, six weeks and twelve weeks. [ Time Frame: Baseline, six weeks and twelve weeks ]
    Plaque index using Turesky Plaque Index

  4. Bleeding Scores to see if there are any changes in bleeding at two weeks, six weeks and twelve weeks. [ Time Frame: Baseline, six weeks and twelve weeks. ]
    Check for bleeding sites


Secondary Outcome Measures :
  1. Plaque samples to see if there is any change in samples at two weeks, six weeks, and twelve weeks. [ Time Frame: Baseline, six weeks and twelve weeks. ]
    Plaque samples will be collected from the following four sites- mesial surface of maxillary first molar on left side, distal surface of maxillary first premolar on right side, mesial surface of mandibular second molar on left side and distal surface of mandibular lateral incisor on right side. These samples will be analyzed for composition of oral microbial flora.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Be between the ages of 18 and 60
  • Provide written informed consent prior to participation and be given a signed copy of the informed consent form (ICF).
  • Be in good general health as determined by the investigator/designee based on a review of the Medical history/update for participation in the study;
  • Have at least 20 gradable teeth;
  • Have 10 or more bleeding sites at Baseline

Exclusion Criteria:

  • Known allergies or sensitivity to oral rinse products, especially those containing cetylpyridinium chloride (CPC), sodium hydroxide or potassium dihydrogen phosphate.
  • Severe periodontal disease, as characterized by purulent exudate, generalized mobility, and/or severe recession.
  • Active treatment for periodontitis.
  • Braces
  • Diabetes
  • Antibiotic use within three months of the Baseline, Visit 1.
  • Pregnancy
  • Any diseases or conditions that could be expected to interfere with the subject safely completing the study.

Continuance Criteria

Subjects may be excluded from the study or the analysis due to:

  • Use of antibiotics any time during the study;
  • Use of any non-study oral hygiene products during the study;
  • A non-study dental prophylaxis or other elective dentistry during the study

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): NCT03154021


Locations
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United States, Florida
Dental Clinical Research Unit, University of Florida
Gainesville, Florida, United States, 32610
University of Florida College of Dentistry
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
University of Florida
Next Science LLC
Investigators
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Principal Investigator: Ann Progulske-Fox, PhD University of Florida

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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT03154021     History of Changes
Other Study ID Numbers: IRB201700505
CSP-007 ( Other Identifier: University of Florida )
First Posted: May 15, 2017    Key Record Dates
Last Update Posted: February 18, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Florida:
Gingival Index
Plaque Index
Bleeding
Pocket Depth
Additional relevant MeSH terms:
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Gingivitis
Dental Plaque
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Dental Deposits
Tooth Diseases