Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02676219
Other study ID # ORL-IST-2190
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 1, 2015
Est. completion date September 18, 2015

Study information

Verified date June 2018
Source Unilever R&D
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date September 18, 2015
Est. primary completion date September 18, 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

2. Recurrent or regular aphthous ulcers.

3. Severe gingivitis, carious lesions treated and untreated periodontal disease.

4. Excessive signs of dental erosion or a previous history of being susceptible to high dental erosion after drinking acidic drinks

5. Tooth bleaching within past 2 months.

6. Suffer from dentine hypersensitivity.

5. Allergy/Intolerance Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.

6. Clinical Study/Experimental Medication

1. Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit.

2. Previous randomisation into this study.

7. Substance abuse Recent history (within the last year) of alcohol or other substance abuse.

8. Personnel An employee of the sponsor, member of the study site or a staff family relative. The site for this protocol is the Clinical Trials Unit in the Bristol Dental School and Hospital. Employees of the Bristol Dental School and Hospital not associated with the Clinical Trials Unit are eligible to participate.

9. Any participant who, in the judgement of the investigator, should not participate in the study.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
RS01
Oral Care product containing sodium monofluorophosphate and sodium fluoride
Water


Locations

Country Name City State
United Kingdom School of Oral and Dental Science Bristol

Sponsors (2)

Lead Sponsor Collaborator
Unilever R&D Bristol Dental School and Hospital

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary changes in enamel surface topography using an impression methodology with scanning electron microscopy 6 hours
Secondary changes in enamel surface topography using an impression methodology with scanning electron microscopy 2 hours
See also
  Status Clinical Trial Phase
Completed NCT02548156 - Intra Oral Kinetics of Fluoride Containing Dentifrices N/A
Completed NCT02533466 - In Vivo Investigation of Initial Stages of Enamel Erosion N/A
Completed NCT04586322 - Association Between Erosive Tooth Wear Progression and Dietary Risk Factors.
Active, not recruiting NCT03112278 - Clinical Evaluation of Ultrathin Occlusal Veneers for the Treatment of Severe Dental Erosion N/A
Completed NCT01622920 - Preliminary Clinical Study of Ultrasound to Measure Enamel Thickness Phase 1
Completed NCT00564330 - In Vivo Quantification of Dental Demineralisation Using OCT With and Without Esomeprazole Phase 1/Phase 2
Completed NCT03296072 - In Situ Erosion Study to Investigate the Effectiveness of an Experimental Toothpaste Phase 3
Completed NCT03101943 - Preventing Early Childhood Obesity, Part 1: Family Spirit Nurture, 3-9 Months N/A
Completed NCT03515902 - The Effects of Mouthguard and Desensitizing Toothpaste in Reducing Dental Hypersensitivity N/A
Completed NCT05146557 - Associations Between Obesity, Dental Caries, Erosive Tooth Wear and Periodontal Disease in Adolescents: A Case Control-study
Completed NCT03577834 - The Effect of Vinegar Consumption on Visceral Fat and Blood Glucose Concentration N/A
Completed NCT06242444 - An Erosion Study to Investigate the Efficacy of an Experimental Dentifrice to Remineralize Enamel N/A
Completed NCT01128972 - Evaluation of a Test Mouthwash and Dentifrice Regimen in an In-situ Model of Dental Erosion Phase 2
Completed NCT06136754 - Investigate a Varnish to Protect From Erosive Toothwear Phase 3