Novel In Situ Caries and ETW Models Development: Safety and Validation Study

Study on Dental Appliances for Investigational Methods to Study Cavities and Erosive Tooth Wear

Primary Investigator
A

Anderson Hara, DDS

Primary Investigator

Recruiting
18 years - 65 years
All
Phase N/A
10 participants needed
1 Location

Brief description of study

The Oral Health Research Institute (OHRI) has a long history of using partial dentures and oral appliances containing tooth specimens to determine how effective dental products are at reducing cavities and preventing erosive tooth wear (wearing down of the tooth at the gumline). In this study we are asking patients to use a new appliance made from a 3D printer that will fit over their existing lower back teeth that can hold tooth specimen to test dental products for both cavities and erosive tooth wear at the same time. 

The purpose of this study is to test two new methods, one for cavities and one for erosive tooth wear, using tooth specimens placed in 3D-printed lower appliance that will be worn over the patient's existing lower back teeth . The testing to reduce the formation of cavities will be done in specimens placed on the right side (color-coded blue) of the appliance, while reducing the formation of erosive tooth wear will be done in specimens placed on the left side (red) with the specimens tested in the lab independently.

THIS STUDY IS ENROLLING BY INVITATION ONLY - Subjects who previously participated in other Oral Health Research Institute studies (OHRI) or who have contacted OHRI expressing interest in potential studies will be contacted by a team member who will conduct a screening phone interview. If the potential subjects appear to qualify, they will be scheduled for the screening visit.

Detailed description of study

Participants will be asked to wear an appliance containing tooth samples 24 hours a day (except eating and study procedures) for three, three week periods and perform brushing procedures several times per day. 

Subjects cannot chew gum or eat sardines while in the study.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Healthy
  • Age: 18 years - 65 years
  • Gender: All

Inclusion Criteria
In order to participate subjects must:
a.    Provide voluntary, written informed consent;
b.    Be between 18 and 65 years old; 
c.    Understand and be willing, able and likely to comply with all study procedures and restrictions; 
d.    Be willing and capable of wearing a custom-made removable mandibular appliance 24 hours a day for three (3), three-week treatment periods;
e.    Be in good medical and dental health with no active caries or periodontal disease; Note: subjects presenting at screening with caries may continue in the study if their carious lesions are restored prior to beginning treatment 1; and,
f.    Have a salivary flow rate in the range of normal values (unstimulated whole saliva flow rate ≥ 0.2 mL/min; gum base stimulated whole saliva flow rate ≥ 0.8 mL/min);
g.    Have an adequate number of teeth and space to accommodate the custom-made removable mandibular appliance, as per the study PI/study dentist's discretion.

Exclusion Criteria
No subject may:
a.    Be pregnant, intending to become pregnant during the study period or breast feeding;
b.    Have any medical condition that could be expected to interfere with the subject’s safety during the study period (including temporomandibular disorders); 
c.    Be taking antibiotics during the study period, or have taken antibiotics in the two weeks prior to the beginning treatment 1;
d.    Participated in another clinical study or receipt of an investigational drug within 30 days of beginning treatment 1;
e.    Be taking fluoride supplements, required to use a fluoride mouthrinse or have received a professional fluoride treatment in the two weeks preceding specimen placement; or,
f.    Have a history of metal allergies.

This study investigates the use of dental appliances to reduce cavities and erosive tooth wear. Cavities are holes in teeth caused by decay, and erosive tooth wear is the wearing down of teeth at the gumline. The purpose of this study is to test two new methods using a 3D-printed appliance that fits over the lower back teeth. The appliance holds tooth samples to test dental products for both cavities and erosive tooth wear.

Participants will wear the appliance containing tooth samples 24 hours a day, except when eating or during study procedures, for three periods of three weeks each. They will also perform brushing procedures several times per day. The appliance has two sides: the right side (blue) tests for cavity reduction, and the left side (red) tests for reducing erosive tooth wear. The specimens are tested in the lab independently.

  • Who can participate: Participants must be between 18 and 65 years old, in good medical and dental health, and able to wear a custom-made dental appliance. They should not have active caries or periodontal disease unless treated before the study, and must have a normal salivary flow rate.
  • Study details: Participants will wear a custom-made dental appliance for three periods of three weeks each, and perform brushing procedures multiple times a day. They cannot chew gum or eat sardines during the study.
Updated on 09 Oct 2026. Study ID: OHRI-HALEON-31100, 31100

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