A Clinical and Imaging Study to Evaluate a Novel Dentifrice

NCT02271815 | Completed

• 2 other identifiers: 20139778Livionex, Inc.
• Study Type: observational
• Target: 194
• Locations: 1 country
• Sites: 1

Brief Summary

There is a need for toothpastes that more effectively remove oral biofilm, inhibit biofilm re-formation and support periodontal health. This is particularly important for patients with long-term orthodontic fixtures or prosthodontic appliances, and also for debilitated, diabetic and immunocompromised patients. The objective of this study is to evaluate the effects of toothpastes on plaque presence and removal, gingival and periodontal health, dental hard tissue mineralization, erosion, abrasion, and microstructure as well as dry/sore mouth. In addition to clinical scoring and photographs, tooth and gum sensitivity, saliva volume, pH and buffering and enamel health may be evaluated using tooth samples worn on removable dental retainers. These samples will be examined outside of the mouth using advanced optical techniques such as Optical Coherence Tomography (OCT), Fluorescence, various forms of microscopy and spectroscopy.

Conditions

Gingivitis; Periodontitis; Dental Plaque

Keywords

toothpaste; dental gel; dentifrice; plaque removal; oral biofilm; plaque accumulation

Outcome Measures

Primary Outcomes (8)

• Gingival health measure 1

  Gingival Index

  Up to 6 months

• Gingival health measure 2

  Sulcus Bleeding Index

  Up to 6 months

• Gingival health measure 3

  Optical Coherence Tomography

  Up to 6 months

• Periodontal health measure 1

  Optical Coherence Tomography

  Up to 6 months

• Periodontal health measure 2

  Periodontal Pocket Depths

  Up to 6 months

• Plaque removal and reaccumulation measure 1

  Plaque Index

  Up to 6 months

• Plaque removal and reaccumulation measure 2

  Optical Coherence Tomography

  Up to 6 months

• Plaque removal and reaccumulation measure 3

  Multiphoton microscopy

  Up to 6 months

Secondary Outcomes (6)

• Plaque characterization

  Up to 6 months

• Enamel health measure 1

  Up to 6 months

• Enamel health measure 2

  Up to 6 months

• Enamel health measure 3

  Up to 6 months

• Enamel health measure 4

  Up to 6 months

Study Arms (1)

Oral Hygiene

Oral Hygiene

Other: Oral Hygiene

Interventions

Oral Hygiene OTHER

Oral Hygiene

Oral Hygiene

Eligibility Criteria

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

Study Population

Study population will be recruited from University of California Irvine faculty, staff and students as well as individuals residing or working in the UCI neighborhood.

You may qualify if:

• Male or female over the age of 18
• Have a previously diagnosed condition of gingivitis and periodontitis including gingival bleeding, gingival inflammation, plaque, and for some study sections at least four sites with probing pocket depths \> 4mm.
• Not pregnant and not lactating.

You may not qualify if:

• Participated in other clinical study within the last 30 days.
• Plan to receive dental treatment during the study dates.
• History of significant adverse effects following use of oral hygiene products such as toothpastes and mouth rinses.
• Allergies to personal care/consumer products or their ingredients.
• Less than 20 teeth (excluding third molars).
• For some studies, within six months prior to baseline, any quadrant or maintenance S/RP, and/or periodontal surgical therapy
• Diagnosed with active acquired immunodeficiency syndrome (AIDS) or Hepatitis B/C and other significant disease or disorder.
• Poorly controlled diabetes
• History of herpetic infection, recurrent aphthous ulcer, or other ulcerative diseases, abscesses, granulomas.
• History of or currently undergoing immunosuppression
• Taken antibiotics in the previous 3 months.
• Taking anti-inflammatory medications or Immunosuppressants.

Sponsors & Collaborators

• University of California, Irvine: lead
• Livionex Inc.: collaborator

Study Sites (1)

Beckman Laser Institute, University of california, Irvine

Irvine, California, 92612, United States

Location

MeSH Terms

Conditions

Gingivitis; Periodontitis; Dental Plaque

Interventions

Oral Hygiene

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Dental Deposits; Tooth Diseases

Intervention Hierarchy (Ancestors)

Hygiene; Therapeutics; Preventive Dentistry; Dentistry

Study Officials

• Petra Wilder-Smith, DDS, DMD, PhD

  Beckman Laser Institute, UCI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Director of Dentistry

Study Record Dates

• First Submitted: October 9, 2014
• First Posted: October 22, 2014
• Study Start: October 1, 2014
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: September 15, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)