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

NCT02676219 | Completed

• 1 other identifier: ORL-IST-2190
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tooth Erosion

Outcome Measures

Primary Outcomes (1)

• changes in enamel surface topography using an impression methodology with scanning electron microscopy

  6 hours

Secondary Outcomes (1)

• changes in enamel surface topography using an impression methodology with scanning electron microscopy

  2 hours

Study Arms (2)

RS01

EXPERIMENTAL

oral care product containing containing sodium monofluorophosphate and sodium fluoride

Other: RS01

Water

PLACEBO COMPARATOR

Water

Other: Water

Interventions

RS01 OTHER

Oral Care product containing sodium monofluorophosphate and sodium fluoride

RS01

Water OTHER

Water

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Age: Aged at least 18 years.
• Compliance: Understands and is willing, able and likely to comply with all study procedures and restrictions.
• 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.
• Diagnosis:
• Study teeth must show no signs of exposed dentine at the cervical margin.
• In the opinion of the investigator the study teeth must have a healthy gingiva as determined during the OST examination.

You may not qualify if:

• Pregnancy Women who are known to be pregnant or who are intending to become pregnant over the duration of the study.
• Breast-feeding Women who are breast-feeding.
• Disease
• Current or recurrent disease/dental pathology that could affect the assessments.
• In the judgement of the investigator or medically qualified designee, any condition or medication which is causing cause Xerostomia.
• Diabetes Mellitus.
• Susceptibility to acid regurgitation.
• Be susceptible to high dental erosion after drinking acidic soft drinks or juices
• 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.
• Recurrent or regular aphthous ulcers.
• Severe gingivitis, carious lesions treated and untreated periodontal disease.
• Excessive signs of dental erosion or a previous history of being susceptible to high dental erosion after drinking acidic drinks
• Tooth bleaching within past 2 months.
• Suffer from dentine hypersensitivity.
• Allergy/Intolerance Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.

Sponsors & Collaborators

• Unilever R&D: lead
• University of Bristol Dental Hospital: collaborator

Study Sites (1)

School of Oral and Dental Science

Bristol, BS1 2LY, United Kingdom

Location

MeSH Terms

Conditions

Tooth Erosion

Interventions

Water

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Tooth Wear

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• Nicola X West, BDS

  University of Bristol Dental Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2015
• First Posted: February 8, 2016
• Study Start: July 1, 2015
• Primary Completion: September 18, 2015
• Study Completion: September 18, 2015
• Last Updated: June 8, 2018

Record last verified: 2018-06

Locations

GB (1)