A Clinical and Imaging Study to Evaluate a Novel Dentifrice
|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.|
|ClinicalTrials.gov Identifier: NCT02271815|
Recruitment Status : Recruiting
First Posted : October 22, 2014
Last Update Posted : June 7, 2018
|Condition or disease||Intervention/treatment|
|Complication of Personal Oral Hygiene||Other: Oral Hygiene|
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.
|Study Type :||Observational|
|Estimated Enrollment :||30 participants|
|Official Title:||A Clinical and Imaging Study to Evaluate a Novel Dentifrice|
|Study Start Date :||October 2014|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
Other: Oral Hygiene
- 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.
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
|Contact: Petra Wilder-Smith, DDS.,Ph.Dfirstname.lastname@example.org|
|Contact: Montana Compton, RNemail@example.com|
|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|
|Principal Investigator:||Petra Wilder-Smith, PhD||Beckman Laser Institute, UCI|