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A Clinical and Imaging Study to Evaluate a Novel Dentifrice

This study is currently recruiting participants.
Verified May 2017 by Beckman Laser Institute and Medical Center, University of California, Irvine
Sponsor:
ClinicalTrials.gov Identifier:
NCT02271815
First Posted: October 22, 2014
Last Update Posted: May 9, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Beckman Laser Institute University of California Irvine
Essentialis, Inc.
Orahealth
Information provided by (Responsible Party):
Beckman Laser Institute and Medical Center, University of California, Irvine
  Purpose
There is a need for toothpastes that more effectively remove oral biofilm, and inhibit biofilm re-formation. 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, dental hard tissue mineralization, erosion, abrasion and microstructure as well as gingival and periodontal health and dry/sore mouth. In addition to clinical scoring and photographs, measurements of tooth and gum sensitivity, saliva volume, pH and buffering, variables 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.

Condition Intervention
Complication of Personal Oral Hygiene Other: Oral Hygiene

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Clinical and Imaging Study to Evaluate a Novel Dentifrice

Resource links provided by NLM:


Further study details as provided by Beckman Laser Institute and Medical Center, University of California, Irvine:

Primary Outcome Measures:
  • Healthy Gum [ Time Frame: up to 4 weeks ]
    Evaluate the effects of the toothpastes by using Optical Coherence Tomography imaging and Multiphoton Microscopy imaging devices.


Estimated Enrollment: 30
Study Start Date: October 2014
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Oral Hygiene
Oral Hygiene
Other: Oral Hygiene
Oral Hygiene

Detailed Description:

The objective of this study is to evaluate the effects of a novel dental gel, on de- and re-mineralization and the microstructure of the enamel surface in vivo of teeth and on the gingival soft tissue. The purpose of this study is to evaluate the effects of over-the-counter toothpaste Colgate product, Crest Cavity Protection toothpaste and Zendium Classic toothpaste and use imaging devices call Optical Coherence Tomography and Multiphoton Microscopy to measure the change in oral tissue.

Imaging devices are:

  • Optical Coherence Tomography, this imaging device can be used to identify the presence of the inflammation of the gum. The inflammation presence in the gingival pockets and compare to the effect of the toothpaste.
  • Multiphoton Microscopy, this imaging device can be used to identify the presence of the bacterial. The results can determine effects of the toothpaste on the development and breakup of bacterial and any other changes.

In the first part of this study, 15 subjects moderate gingival inflammation (Löe and Silness Gingival Index ≥2) and pocket depths <4 will be randomly assigned to brush twice daily for 21 days with the test or the control dental gel. On Days 0, 7, 14 and 21, plaque levels (Quigley-Hein, Turesky Modification Plaque Index), gingival inflammation (Löe and Silness Gingival Index) and gingival bleeding (modified Sulcus Bleeding Index) will be determined by one blinded, investigator (Dr. Wilder-Smith) using a pressure sensitive probe. In vivo Optical Coherence Tomography (OCT) and Multiphoton Microscopy (MPM) will be used for in situ imaging. The results from this study will help evaluate the effects of the test dentifrice formulation on plaque removal and maintaining gingival health.

In the second part of this study, in 15 subjects, plaque formation and removal will be quantified using ex vivo Optical Coherence Tomography (OCT) and Multiphoton Microscopy (MPM) imaging of small enamel chips mounted on a simple intra-oral retainer. In this cross over design study the subjects will attend the test site on 11 occasions over an 11 week period. Subjects will have an intra oral retainer manufactured which will be worn for a minimum of 22 hours per day and will have up to 8 sterile human enamel inserts fitted.

The second part of the study will be conducted in three legs with a maximum of 44h of retainer wear each, and each leg will follow the same procedure. 2 different over-the-counter toothpastes and a water control will be used for each leg of the study respectively. There will be a minimum of two weeks between each leg.

The third part of this study will involve 5 subjects with no specific oral health issues. The protocol will involve 3 subjects wearing simple retainers for 3 periods of 2 weeks each with 5 sterilized UCI IRB Approved: 07-22-2016 | MOD# 18976 | HS# 2013-9778 1 of 32 enamel chips attached in the palate area. The study will have 3 legs using a control and 2 active toothpastes. There will be washout of 1-2 weeks between each leg. (Section 3 has been completed as of July 11, 2016)

The fourth part of this study will involve 5 subjects with xerostomia. Subjects will wear simple removable retainers for 2 periods of 1 week each, with 5 sterilized demineralized enamel chips attached in the palate area Fresh enamel chips will be used for each leg of the study. After study completion, chips will be used for Scanning Electron microscopy (SEM) and microhardness measurement. We will provide custom retainers made from impressions of each subject. Upon conclusion of the study, we will analyze the effects of Livionex or Xylimelts use on surface enamel using SEM and microhardness data.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Study population will be selected from University of California Irvine staffs and students
Criteria

Inclusion Criteria:

  • Male or female over the age of 18 of all ages.
  • Have a previously diagnosed condition of gingivitis including gingival bleeding and plaque.
  • Non-smoker.
  • Not pregnant or not lactating.

Exclusion Criteria:

  • 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.
  • Have allergies to personal care/consumer products or their ingredients.
  • Have less than 20 teeth (excluding third molars).
  • Have been diagnosis with active acquired immunodeficiency syndrome (AIDS) or Hepatitis B/C and other significant disease or disorders.
  • Have a history of herpetic infection, recurrent apthous ulcer, or other ulcer forming diseases, abscesses, granulomas, or severe gingivitis.
  • Have a history of or are currently taking immunosuppression.
  • Have a history of taken antibiotics in the previous 3 months.
  Contacts and Locations
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): NCT02271815


Contacts
Contact: Petra Wilder-Smith, DDS.,Ph.D 949.824.7632 pwsmith@uci.edu
Contact: Montana Compton, RN 949-824-9265 mocomton@uci.edu

Locations
United States, California
Beckmam Laser Institute Recruiting
Irvine, California, United States, 92612
Contact: Montana Compton, RN    949-824-9265      
Principal Investigator: Petra Wilder-Smith, PhD         
Sub-Investigator: Montana Compton, RN         
Sub-Investigator: Janet Ajdaharian, BS         
Sub-Investigator: Karan Sahni, BS         
Sub-Investigator: Carla Castro, BS         
Sub-Investigator: Afarin Golabgir, BS         
Sponsors and Collaborators
University of California, Irvine
Beckman Laser Institute University of California Irvine
Essentialis, Inc.
Orahealth
Investigators
Principal Investigator: Petra Wilder-Smith, PhD Beckman Laser Institute, UCI
  More Information

Responsible Party: Beckman Laser Institute and Medical Center, Petra Wilder-Smith, DDS., PhD., Professor, Director of Dentistry, University of California, Irvine
ClinicalTrials.gov Identifier: NCT02271815     History of Changes
Other Study ID Numbers: NIH/LAMMP-2013-9778
Unilever ( Other Identifier: Unilever )
First Submitted: October 9, 2014
First Posted: October 22, 2014
Last Update Posted: May 9, 2017
Last Verified: May 2017