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Pilot Study Utilising an Impression Technique to Capture in Vivo Images of Teeth | Clinical Trials | Clareo Health

COMPLETEDNA

Pilot Study Utilising an Impression Technique to Capture in Vivo Images of Teeth

Pilot Study to Investigate the Reparative Effect of a Two Phase Oral Care Product Containing SMFP and NaF on Enamel Against a Dietary Acid Exposure Utilising an Impression Technique to Capture in Vivo Images of Teeth

NCT02676219•Unilever R&D

View on ClinicalTrials.gov

Summary

The study design is a randomised, split mouth, blind with respect to study analysts (microscopist, image grader) two treatment clinical study in 10 healthy participants with sound tooth enamel. The study will comprise of a screening visit, pre-baseline visit and 5 subsequent clinic visits. At the screening visit, participants will give consent to participate in the study. Medical history and concomitant medications will be recorded. Eligibility will be determined following an oral soft tissue (OST) examination and an evaluation of dentition exclusions. Two suitable anterior teeth will be identified for study assessments, these teeth must be at least one tooth apart in the mouth. Saliva samples will be collected from the participants at set points during the study to look at any changes in salivary pH.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Consent: Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
•2. Age: Aged at least 18 years.
•3. Compliance: Understands and is willing, able and likely to comply with all study procedures and restrictions.
•4. General Health: Good general health with (in the opinion of the investigator or medically qualified designee) no clinically significant and relevant abnormalities of medical history or physical examination.
•5. Diagnosis:
•1. Study teeth must show no signs of exposed dentine at the cervical margin.
•2. In the opinion of the investigator the study teeth must have a healthy gingiva as determined during the OST examination.

Exclusion Criteria

•1. Pregnancy Women who are known to be pregnant or who are intending to become pregnant over the duration of the study.
•2. Breast-feeding Women who are breast-feeding.
•3. Disease
•1. Current or recurrent disease/dental pathology that could affect the assessments.
•2. In the judgement of the investigator or medically qualified designee, any condition or medication which is causing cause Xerostomia.
•3. Diabetes Mellitus.
•4. Susceptibility to acid regurgitation.
•5. Be susceptible to high dental erosion after drinking acidic soft drinks or juices
•4. General Dental Exclusions
•1. Any orthodontic appliances, restorations, bridgework or dentures that would interfere with the study evaluations or scheduled for such treatment within the timescale of the study.
+12 more criteria

Locations (1)

School of Oral and Dental Science

Bristol, United Kingdom

Key Dates

Start Date

July 1, 2015

Primary Completion Date

September 18, 2015

Completion Date

September 18, 2015

Last Updated

June 8, 2018

Enrollment

ACTUAL participants

Conditions

Tooth Erosion

Interventions

RS01

OTHER

Water

OTHER

Hydroxyapatite Toothpastes and Enamel Remineralization:

NCT07069218

Enamel HypomineralizationTooth Erosion

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COMPLETEDPHASE3

In Situ Erosion Study to Investigate the Effectiveness of an Experimental Toothpaste

NCT03296072

Tooth Erosion

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 8, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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