Efficacy of Three Toothpastes Using an in Situ Caries Model

Dental Caries Clinical Trial

Official title:

Clinical Efficacy of Three Experimental Toothpastes Using an in Situ Caries Model

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02751320
• Other study ID #: 202301
• Status: Completed
• Phase: N/A
• First received: April 21, 2016
• Last updated: October 11, 2017
• Start date: February 1, 2016
• Est. completion date: August 11, 2016

Study information

• Verified date: July 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: August 11, 2016
• Est. primary completion date: July 1, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Caries

Intervention

Drug:
• 0.425 % w/w phytate,1150ppm F
Participants were assigned with 1.5±0.1g twice daily dentifrice for one timed minute.
• 0.85 % w/w phytate,1150ppm F
Participants were assigned with 1.5±0.1g twice daily dentifrice for one timed minute.
• 0.85 % w/w phytate,0.3%ZnCl2 0.5% sodium citrate, 1150ppm F
Participants were assigned with 1.5±0.1g twice daily dentifrice for one timed minute.

Other:
• 0 ppm F
Participants were assigned with 1.5±0.1g twice daily dentifrice for one timed minute.

Drug:
• 1150ppm F
Participants were assigned with 1.5±0.1g twice daily dentifrice for one timed minute.
• 0.3%ZnCl2, 0.5% sodium citrate, 1150ppm F
Participants were assigned with 1.5±0.1g twice daily dentifrice for one timed minute.

Locations

Country	Name	City	State
United States	GSK Investigational Site	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage Surface Microhardness Recovery (SMHR) of Phyte (0% 0.425% and 0.85%) at 2 Weeks	SMHR test was used to assess the changes in mineralization status of partially demineralized enamel specimens using a Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. % SMHR was calculated from indentation length (micrometer [µm]) of sound enamel specimen at baseline (B), indentation length (µm) after in vitro demineralization(D), indentation length (µm) after intra-oral exposure (R): [D-R/D-B]*100.	Baseline upto 2 weeks
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	SMHR test was used to assess the changes in mineralization status of partially demineralized enamel specimens using a Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. % SMHR was calculated from indentation length (µm) of sound enamel specimen at baseline (B), indentation length (µm) after in vitro demineralization(D), indentation length (µm) after intra-oral exposure (R): [D-R/D-B]*100.	Baseline upto 2 weeks
Secondary	Transverse Microradiography (TMR) Net Remineralization Change (?M) Value of Phytate (0% 0.452% and 0.85%) at 4 Weeks	TMR was used to assess changes in the mineral status of partially demineralized enamel specimens. Lesions were analyzed at baseline and Integrated Mineral Loss (?Z): (?Z =(lesion depth x 87) - area under the curve [Area under the curve which relates volume % mineral at distances from the specimen surface with respect to section thickness]). After treatment a further section was taken from each lesion specimen for radiography assessment; ?Z was calculated. The change which occurred in mineral content (?M) of the lesions as a result of treatment was calculated by: ?M= (baseline ?Z - Post-treatment ?Z).	Baseline upto 4 weeks
Secondary	TMR ?m 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	TMR was used to assess changes in the mineral status of partially demineralized enamel specimens. Lesions were analyzed at baseline and Integrated Mineral Loss (?Z): (?Z =(lesion depth x 87) - area under the curve [Area under the curve which relates volume % mineral at distances from the specimen surface with respect to section thickness]). After treatment a further section was taken from each lesion specimen for radiography assessment; ?Z was calculated. The change which occurred in mineral content (?M) of the lesions as a result of treatment was calculated by: ?M= (baseline ?Z - Post-treatment ?Z).	Baseline upto 4 weeks
Secondary	Enamel Fluoride Uptake (EFU) of All Study Formulation Variables	The microdrill enamel biopsy technique was used to analyze the fluoride uptake by enamel. Each enamel specimen was mounted on the long axis of a drill attached to a microdrill and drilled to a depth of approximately 100 µm through the entire lesion (four cores per specimen). The enamel powder pooled from four drilling samples was then immediately analyzed for fluoride content using fluoride specific electrode and pH/ion meter. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores and expressed as µg/cm^2.	At Week 2
Secondary	Enamel Fluoride Uptake (EFU) of All Study Formulation Variables	The microdrill enamel biopsy technique was used to analyze the fluoride uptake by enamel. Each enamel specimen was mounted on the long axis of a drill attached to a microdrill and drilled to a depth of approximately 100 µm through the entire lesion (four cores per specimen). The enamel powder pooled from four drilling samples was then immediately analyzed for fluoride content using fluoride specific electrode and pH/ion meter. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores and expressed as µg/cm^2.	At Week 4