Next Science Antimicrobial Mouth Rinse Study

NCT03154021 | Completed Phase 1

• 2 other identifiers: IRB201700505CSP-007
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 2

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.

Conditions

Gingivitis; Dental Plaque

Keywords

Gingival Index; Plaque Index; Bleeding; Pocket Depth

Outcome Measures

Primary Outcomes (4)

• Oral Exam to see if there are any changes in pocket depths at two weeks, six weeks and twelve weeks

  Complete oral exam with charting of pocket depths

  Baseline, six weeks and twelve weeks.

• Gingival Index to see if there are any changes in gingival index at two weeks, six weeks and twelve weeks.

  Gingival Index using Loe and Silness Gingival index

  Baseline, six weeks and twelve weeks.

• Plaque index to see if there are any changes in plaque scores at two weeks, six weeks and twelve weeks.

  Plaque index using Turesky Plaque Index

  Baseline, six weeks and twelve weeks

• Bleeding Scores to see if there are any changes in bleeding at two weeks, six weeks and twelve weeks.

  Check for bleeding sites

  Baseline, six weeks and twelve weeks.

Secondary Outcomes (1)

• Plaque samples to see if there is any change in samples at two weeks, six weeks, and twelve weeks.

  Baseline, six weeks and twelve weeks.

Study Arms (2)

Gingivitis Test

EXPERIMENTAL

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

Gingivitis Placebo

PLACEBO COMPARATOR

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

Interventions

Next Science OTC Oral Rinse with Essential Oils COMBINATION_PRODUCT

This group will receive Next Science Oral Rinse with Essential Oils and the other half will be give OTC Oral Rinse Control

Gingivitis Test

OTC Oral Rinse Control COMBINATION_PRODUCT

This group will receive OTC Oral Rinse Control

Gingivitis Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead
• Next Science LLC: collaborator

Study Sites (2)

Dental Clinical Research Unit, University of Florida

Gainesville, Florida, 32610, United States

Location

University of Florida College of Dentistry

Gainesville, Florida, 32610, United States

Location

Related Publications (1)

• Newman BA, Rosebrough CN, Tamashiro RA, Dias Ribeiro AP, Whitlock JA, Sidhu G, Aukhil I, Porral DY, Progulske-Fox A, Myntti MF, Wang GP. A randomized controlled trial to evaluate the effectiveness of a novel mouth rinse in patients with gingivitis. BMC Oral Health. 2022 Nov 2;22(1):461. doi: 10.1186/s12903-022-02518-2.

  PMID: 36324127 DERIVED

MeSH Terms

Conditions

Gingivitis; Dental Plaque; Hemorrhage

Interventions

Oils, Volatile

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Dental Deposits; Tooth Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Oils; Lipids

Study Officials

• Ann Progulske-Fox, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: One half of subjects will be given test product other half will be given placebo.

Study Record Dates

• First Submitted: May 5, 2017
• First Posted: May 15, 2017
• Study Start: August 28, 2017
• Primary Completion: March 8, 2018
• Study Completion: May 15, 2018
• Last Updated: February 18, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)