Evaluation of Efficacy of Experimental Gel to Foam Dentifrices in Dental Erosion

GlaxoSmithKline (GSK)

Status

Completed

Conditions

Dental Erosion

Acid Wear

Treatments

Drug: Potassium nitrate

Drug: Sodium Fluoride

Study type

Interventional

Funder types

Industry

Identifiers

NCT01657903

Z6961385

Details and patient eligibility

About

The purpose of this study is to compare and evaluate the ability of two European Union (EU) regulated gel to foam toothpaste formulations versus a non-fluoride toothpaste using a modified in-situ model of dental erosion and remineralization. A positive control i.e fluoride containing toothpaste marketed in EU will also be compared to non-fluoride toothpaste.

Full description

The aim of this study is to assess the remineralization effects of two EU gel to foam toothpaste formulations with 1450 parts per million (ppm) of fluoride as sodium fluoride (NaF) and 5% potassium nitrate (KNO3) versus a non-fluoride (0 ppm F)/KNO3 toothpaste as a negative control. The two experimental gel to foam toothpaste formulations differ in their relative dentine abrasivity (RDA) values which is an in-vitro measure of a toothpaste abrasivity to the dentinal tissues. A marketed toothpaste containing NaF and KNO3 will serve as a positive control.

Enrollment

56 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

General and Oral Health: Good general health with (in the opinion of the investigator) no clinically OST and OHT examinations.
Oral Requirements:
- An intact maxillary dental arch suitable for the retention of the palatal appliance and an intact mandibular dental arch. Subjects may have fixed bridges replacing missing teeth.
- A gum base stimulated whole saliva flow rate ≥ 0.8 g/min and an unstimulated whole saliva flow rate ≥ 0.2 g/min.
Contraception: Women of childbearing potential who are, in the opinion of the investigator, practicing a reliable method of contraception.

Exclusion criteria

Oral Health:
- Current active caries or periodontal disease that may compromise the study or the health of the subjects.
- Lesions of the oral cavity that could interfere with the study evaluations, including severe gingivitis, grossly carious lesions, periodontitis and other severe periodontal disease.
Allergy/Intolerance: Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
Clinical Study/Experimental Medication:
- Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit
- Previous participation in this study
Substance abuse: Recent history (within the last year) of alcohol or other substance abuse.
Pregnancy: Women who are pregnant or who are intending to become pregnant over the duration of the study
Breast-feeding: Women who are breast-feeding

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

56 participants in 4 patient groups, including a placebo group

NaF/KNO3 toothpaste, Low RDA

Experimental group

Description:

Participants to brush with 1.5 g of low RDA gel to foam toothpaste containing 1450 ppm F - EU level as NaF. All study treatments contain 5% weight by weight (w/w) KNO3.

Treatment:

Drug: Potassium nitrate

Drug: Sodium Fluoride

NaF/KNO3 toothpaste, Medium RDA

Experimental group

Description:

Participants to brush with 1.5 g of medium RDA gel to foam toothpaste containing 1450 ppm F - EU level as NaF. All study treatments contain 5% w/w KNO3.

Treatment:

Drug: Potassium nitrate

Drug: Sodium Fluoride

NaF/KNO3 toothpaste

Active Comparator group

Description:

Participants to brush with 1.5 g of NaF/KNO3 toothpaste containing 1450 ppm F - EU level as NaF. All study treatments contain 5% w/w KNO3.

Treatment:

Drug: Potassium nitrate

Drug: Sodium Fluoride

No fluoride/KNO3 toothpaste

Placebo Comparator group