Efficacy of Three Toothpastes Using an in Situ Caries Model
| Status: | Completed |
|---|---|
| Conditions: | Other Indications, Dental |
| Therapuetic Areas: | Dental / Maxillofacial Surgery, Other |
| Healthy: | No |
| Age Range: | 18 - 85 |
| Updated: | 10/15/2017 |
| Start Date: | February 1, 2016 |
| End Date: | August 11, 2016 |
Clinical Efficacy of Three Experimental Toothpastes Using an in Situ Caries Model
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).
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).
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.
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