Last updated: 07/17/2024 17:36:28
In situ erosion study to investigate the effectiveness of an experimental toothpaste
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A randomized, examiner blind, crossover, in situ erosion study to investigate the efficacy of an experimental dentifrice in remineralization of previously softened enamel compared to a placebo dentifrice
Trial description: This will be a randomized, controlled, single center, single- blind, 3 period, 3 treatment, cross-over, in situ design which consists of placing pre-eroded bovine enamel specimens intra orally using a palatal appliance and testing the remineralizing performance of the experimental (dentifrice containing 0.254 Percent weight by weight [%, w/w] sodium fluoride (1150 parts per million [ppm] fluoride) and 5% KNO3 [potassium nitrate]), comparator (dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride) and placebo (Fluoride free placebo containing 5% KNO3 [0 ppm fluoride] ) dentifrices 2 and 4 hours (hrs) post treatment application, based on surface micro hardness measurements. This study will be carried out in healthy adults with a maxillary dental arch suitable for the retention of the palatal appliance.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
% surface micro hardness recovery (SMHR; comparison of 1150 ppm fluoride and 5% KNO3 dentifrice relative to a fluoride free placebo dentifrice to enhance remineralization of enamel)
Timeframe: After 4 hrs following single exposure of treatment
Secondary outcomes:
% Relative erosion resistance (RER; comparison of 1150 ppm fluoride and 5% KNO3 dentifrice relative to a fluoride free placebo dentifrice to inhibit demineralization of enamel)
Timeframe: After 4 hrs following single exposure of treatment
Enamel Fluoride Uptake (EFU; comparison of 1150 ppm fluoride and 5% KNO3 dentifrice relative to a fluoride free placebo dentifrice to promote fluoride uptake in enamel)
Timeframe: After 4 hrs following single exposure of treatment
%SMHR (comparison of 1150 ppm fluoride and 5% KNO3 dentifrice relative to comparator containing 1100 ppm fluoride)
Timeframe: After 4 hrs following single exposure of treatment
% RER (comparison of 1150 ppm fluoride and 5% KNO3 dentifrice relative to comparator containing 1100 ppm fluoride)
Timeframe: After 4 hrs following single exposure of treatment
EFU (comparison of 1150 ppm fluoride and 5% KNO3 dentifrice relative to comparator containing 1100 ppm fluoride)
Timeframe: After 4 hrs following single exposure of treatment
Interventions:
Drug: 0.254% w/w sodium fluoride and 5% KNO3
Drug: 0.454% w/w stannous fluoride
Drug: 5% KNO3
Enrollment:
62
Observational study model:
Not applicable
Primary completion date:
2018-16-01
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
tooth erosion
Product
SKF46655, potassium nitrate, potassium nitrate/sodium fluoride, sodium fluoride
Collaborators
Not applicable
Study date(s)
November 2017 to January 2018
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18 - 65 years
Accepts healthy volunteers
Yes
- Evidence of a personally signed and dated informed consent.
- Male and female participants who, at the time of screening, are between the ages of 18 and 65 years, inclusive.
- Participants who are investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or participants who are GSK employees directly involved in the conduct of the study.
- Participation in other studies involving investigational drug(s) within 30 days prior to screening visit.
Inclusion and exclusion criteria
Inclusion criteria:
- Evidence of a personally signed and dated informed consent.
- Male and female participants who, at the time of screening, are between the ages of 18 and 65 years, inclusive.
- Participant who is willing and able to comply with scheduled visits, treatment plan, and other study procedures.
- Good general and mental health with, in the opinion of the investigator or medically qualified designee. No clinically significant and relevant abnormalities in medical history or oral examination.
- Male participant able to father children and female participant of childbearing potential and at risk for pregnancy must agree to use a highly effective method of contraception throughout the study and for 5 days after the last dose of assigned treatment.
- Good oral health without lesions of the oral cavity that could interfere with the study evaluations.
- Maxillary dental arch suitable for the retention of the palatal appliance
- Unstimulated salivary flow rate of at least 0.2 mL/minute and a stimulated salivary flow rate of at least 0.8 mL/minute.
- Understands and is willing, able and likely to comply with all study procedures and restrictions.
Exclusion criteria:
- Participants who are investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or participants who are GSK employees directly involved in the conduct of the study.
- Participation in other studies involving investigational drug(s) within 30 days prior to screening visit.
- Participation in other studies involving investigational oral care or cosmetic products within 30 days prior to screening visit.
- Acute or chronic medical or psychiatric condition that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
- Pregnant female participant (self – reported).
- Breastfeeding female participant.
- Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients. Unwilling or unable to comply with the lifestyle guidelines described in this protocol.
- Medication that may interfere significantly with the saliva flow in the judgment of the investigator. Should new medications that may interfere with the saliva flow be added, a second salivary flow test will be performed.
- Participant with any condition that would impact on their safety or wellbeing or affect their ability to understand and follow study procedures and requirements.
- Any sign of grossly carious lesions (active), moderate or severe periodontal conditions, or severe tooth wear. Participant presenting at screening with minor caries may continue in the study if their carious lesions are repaired prior to the first treatment visit of the study.
- Wears oral appliance or orthodontia (besides participants wearing permanent lower retainers, which are eligible).
- Recent history (within the last year) of alcohol or other substance abuse. Participant who has previously been enrolled in this study.
Trial location(s)
Location
GSK Investigational Site
Indianapolis, Indiana, United States, 46202
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2018-16-01
Actual study completion date
2018-16-01
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
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