N/A
N=45
Efficacy of Three Toothpastes Using an in Situ Caries Model
Dental Caries
Bottom Line
View on ClinicalTrials.gov: NCT02751320 ↗Enrolled (actual)
45
Serious AEs
0.6%
Results posted
Oct 2017
Primary outcome: Primary: Percentage Surface Microhardness Recovery (SMHR) of Phyte (0% 0.425% and 0.85%) at 2 Weeks — 25.53; 26.81; 7.41; 28.88 % SMHR — p=0.7603
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 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 (Drug); 0 ppm F (Other); 1150ppm F (Drug); 0.3%ZnCl2, 0.5% sodium citrate, 1150ppm F (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Jul 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Surface Microhardness Recovery (SMHR) of Phyte (0% 0.425% and 0.85%) at 2 Weeks |
25.53; 26.81; 7.41; 28.88 | 0.7603 |
| SECONDARY % 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 |
26.81; 23.38; 28.88; 28.80 | — |
| SECONDARY Transverse Microradiography (TMR) Net Remineralization Change (ΔM) Value of Phytate (0% 0.452% and 0.85%) at 4 Weeks |
3055.36; 2772.96; 3849.83; 2720.00 | — |
| SECONDARY 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 |
2772.96; 2733.33; 2720.00; 2421.25 | — |
| SECONDARY Enamel Fluoride Uptake (EFU) of All Study Formulation Variables |
12.28; 11.09; 14.16; 1.64; 15.29; 15.11 | — |
| SECONDARY Enamel Fluoride Uptake (EFU) of All Study Formulation Variables |
12.28; 11.09; 14.16; 1.64; 15.29; 15.11 | — |
Summary
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).
Eligibility Criteria
Inclusion Criteria
- Demonstrates understanding of the study.
- Aged 18 to 85 years.
- Understands and is willing, able and likely to comply with all study procedures and restrictions.
- Has good general health (in the opinion of the investigator or medically qualified designee).
- 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).
- Currently wearing a removable mandibular partial denture with sufficient room in the posterior buccal flange area to accommodate two enamel specimens.
- Have no current active caries or periodontal disease and all restorations in a good state of repair.
- Willing and capable of brushing their natural teeth with the lower partial denture in place.
Exclusion Criteria
- Pregnant or breast feeding women.
- Known or suspected intolerance or hypersensitivity to the study materials or their stated ingredients.
- Currently taking antibiotics or have taken antibiotics in the two weeks prior to the screening visit.
- Unable to measure product weights accurately using the assigned study scale as determined by the study staff as demonstrated.
- Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit.
- Have received a professional fluoride treatment within 14 days of randomization to the first treatment.
- Recent history (within the last year) of alcohol or other substance abuse.
Data sourced from ClinicalTrials.gov (NCT02751320). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.