Last updated: 11/03/2018 22:21:57
Efficacy of Three Toothpastes Using an in situ Caries Model
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Clinical Efficacy of Three Experimental Toothpastes Using an in situ Caries Model
Trial description: This will be a single-centre, randomized, blinded, placebo-controlled, 6-treatment, 4-period crossover, incomplete block design, in situ caries study in healthy adults who wear a removable bilateral mandibular partial denture. The denture will be modified to accommodate 4 gauze-covered specimens of human dental enamel (4x3mm) that have been previously demineralized in vitro to form either S or low-R lesions (2 specimens of each lesion type will be used with each participant). After 14 days of twice daily product use off-site, the 2 S lesion specimens will be removed at the study site, with the remaining 2 low-R lesion specimens removed at the study site after a further 14 days of product use. To determine the remineralization ability of the treatments, all specimens will be analyzed by transverse microradiography (TMR) and enamel fluoride uptake (EFU), with the S lesions additionally analyzed by surface micro hardness (SMH) and the low-R lesions additionally analyzed by quantitative light fluorescence (QLF).
Primary purpose:
Basic Science
Trial design:
Crossover Assignment
Masking:
Single (Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Percentage Surface Microhardness Recovery (SMHR) of phyte (0% 0.425% and 0.85%) at 2 weeks
Timeframe: Baseline upto 2 weeks
Secondary outcomes:
% SMHR of 0.85% phytate compared to 0% phytate, in presence of 1150ppm fluoride and 0.3% ZnCl2, 0.3% ZnCl2 compared to 0% ZnCl2 in the presence of 1150ppm fluoride and 0.3% ZnCl2 compared to 0% ZnCl2 in the presence of 1150ppm fluoride and 0.85% phytate
Timeframe: Baseline upto 2 weeks
Transverse Microradiography (TMR) net remineralization change (ΔM) value of phytate (0% 0.452% and 0.85%) at 4 weeks
Timeframe: Baseline upto 4 weeks
TMR Δm Value of 0.85% phytate compared to 0% phytate, in the presence of 1150ppm F and 0.3% ZnCl2, 0.3% ZnCl2 compared to 0% ZnCl2 in the presence of 1150ppm F and 0.3% ZnCl2 compared to 0% ZnCl2 in the presence of 1150ppm F and 0.85% phytate
Timeframe: Baseline upto 4 weeks
Enamel Fluoride Uptake (EFU) of all study formulation variables
Timeframe: At Week 2
Enamel Fluoride Uptake (EFU) of all study formulation variables
Timeframe: At Week 4
Interventions:
Drug: 0.425 % w/w phytate,1150ppm F
Drug: 0.85 % w/w phytate,1150ppm F
Drug: 0.85 % w/w phytate,0.3%ZnCl2 0.5% sodium citrate, 1150ppm F
Other: 0 ppm F
Drug: 1150ppm F
Drug: 0.3%ZnCl2, 0.5% sodium citrate, 1150ppm F
Enrollment:
58
Observational study model:
Not applicable
Primary completion date:
2016-11-08
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
dental caries
Product
GI148564, GSK3413759, GSK3519327, GSK3656335, SKF37833, sodium fluoride
Collaborators
Not applicable
Study date(s)
February 2016 to August 2016
Type
Interventional
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18 - 85 years
Accepts healthy volunteers
Yes
- 1. Demonstrates understanding of the study.
- 2. Aged 18 to 85 years.
- 1. Pregnant or breast feeding women.
- 2. Known or suspected intolerance or hypersensitivity to the study materials or their stated ingredients.
Inclusion and exclusion criteria
Inclusion criteria:
- 1. Demonstrates understanding of the study. 2. Aged 18 to 85 years. 3. Understands and is willing, able and likely to comply with all study procedures and restrictions. 4. Has good general health (in the opinion of the investigator or medically qualified designee). 5. A salivary flow-rate in the range of normal values (unstimulated whole saliva flow- Rate ≥ 0.2 g/minute (min); gum base stimulated whole saliva flow-Rate ≥ 0.8 g/min). 6. Currently wearing a removable mandibular partial denture with sufficient room in the posterior buccal flange area to accommodate two enamel specimens. 7. Have no current active caries or periodontal disease and all restorations in a good state of repair. 8. Willing and capable of brushing their natural teeth with the lower partial denture in place.
Exclusion criteria:
- 1. Pregnant or breast feeding women. 2. Known or suspected intolerance or hypersensitivity to the study materials or their stated ingredients. 3. Currently taking antibiotics or have taken antibiotics in the two weeks prior to the screening visit. 4. Unable to measure product weights accurately using the assigned study scale as determined by the study staff as demonstrated. 5. Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit. 6. Have received a professional fluoride treatment within 14 days of randomization to the first treatment. 7. Recent history (within the last year) of alcohol or other substance abuse.
Trial location(s)
Location
GSK Investigational Site
Indianapolis, Indiana, United States, 46202
Status
Study Complete
Study documents
Statistical analysis plan
Available language(s): English
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
Protocol
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
2016-11-08
Actual study completion date
2016-11-08
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.
Additional information about the trial
Additional information
Not applicable
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