Efficacy of Three Toothpastes Using an in Situ Caries Model

NCT ID: NCT02751320

Last Updated: 2017-10-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-01
• Study Completion Date: 2016-08-11

Brief 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).

Conditions

Dental Caries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Experimental Dentifrice1

Participants will brush their natural teeth with a pre-wetted toothbrush and their assigned dentifrice for one timed minute, ensuring the enamel specimens retained within their mouths are not directly brushed. Participants should then rinse their mouths with 15ml of tap water for approximately 10s.

Group Type: EXPERIMENTAL

0.425 % w/w phytate,1150ppm F

Intervention Type: DRUG

Participants were assigned with 1.5±0.1g twice daily dentifrice for one timed minute.

Experimental Dentifrice 2

Participants will brush their natural teeth with a pre-wetted toothbrush and their assigned dentifrice for one timed minute, ensuring the enamel specimens retained within their mouths are not directly brushed. Participants should then rinse their mouths with 15ml of tap water for approximately 10s.

Group Type: EXPERIMENTAL

0.85 % w/w phytate,1150ppm F

Intervention Type: DRUG

Participants were assigned with 1.5±0.1g twice daily dentifrice for one timed minute.

Experimental Dentifrice 3

Participants will brush their natural teeth with a pre-wetted toothbrush and their assigned dentifrice for one timed minute, ensuring the enamel specimens retained within their mouths are not directly brushed. Participants should then rinse their mouths with 15ml of tap water for approximately 10s.

Group Type: EXPERIMENTAL

0.85 % w/w phytate,0.3%ZnCl2 0.5% sodium citrate, 1150ppm F

Intervention Type: DRUG

Participants were assigned with 1.5±0.1g twice daily dentifrice for one timed minute.

Reference Product 1

Participants will brush their natural teeth with a pre-wetted toothbrush and their assigned dentifrice for one timed minute, ensuring the enamel specimens retained within their mouths are not directly brushed. Participants should then rinse their mouths with 15ml of tap water for approximately 10s.

Group Type: PLACEBO_COMPARATOR

0 ppm F

Intervention Type: OTHER

Participants were assigned with 1.5±0.1g twice daily dentifrice for one timed minute.

Reference Product 2

Participants will brush their natural teeth with a pre-wetted toothbrush and their assigned dentifrice for one timed minute, ensuring the enamel specimens retained within their mouths are not directly brushed. Participants should then rinse their mouths with 15ml of tap water for approximately 10s.

Group Type: ACTIVE_COMPARATOR

1150ppm F

Intervention Type: DRUG

Participants were assigned with 1.5±0.1g twice daily dentifrice for one timed minute.

Reference Product 3

Participants will brush their natural teeth with a pre-wetted toothbrush and their assigned dentifrice for one timed minute, ensuring the enamel specimens retained within their mouths are not directly brushed. Participants should then rinse their mouths with 15ml of tap water for approximately 10s.

Group Type: ACTIVE_COMPARATOR

0.3%ZnCl2, 0.5% sodium citrate, 1150ppm F

Intervention Type: DRUG

Participants were assigned with 1.5±0.1g twice daily dentifrice for one timed minute.

Interventions

0.425 % w/w phytate,1150ppm F

Participants were assigned with 1.5±0.1g twice daily dentifrice for one timed minute.

Intervention Type: DRUG

0.85 % w/w phytate,1150ppm F

Participants were assigned with 1.5±0.1g twice daily dentifrice for one timed minute.

Intervention Type: DRUG

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.

Intervention Type: DRUG

0 ppm F

Participants were assigned with 1.5±0.1g twice daily dentifrice for one timed minute.

Intervention Type: OTHER

1150ppm F

Participants were assigned with 1.5±0.1g twice daily dentifrice for one timed minute.

Intervention Type: DRUG

0.3%ZnCl2, 0.5% sodium citrate, 1150ppm F

Participants were assigned with 1.5±0.1g twice daily dentifrice for one timed minute.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Indianapolis, Indiana, United States

Countries

United States

Other Identifiers

202301

Identifier Type: -

Identifier Source: org_study_id