A Clinical and Imaging Study to Evaluate a Novel Dentifrice
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 6/9/2018 |
| Start Date: | October 2014 |
| End Date: | December 2020 |
| Contact: | Petra Wilder-Smith, DDS.,Ph.D |
| Email: | pwsmith@uci.edu |
| Phone: | 949.824.7632 |
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.
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.
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.
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.
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.
We found this trial at
1
site
Irvine, California 92612
Principal Investigator: Petra Wilder-Smith, PhD
Phone: 949-824-9265
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