Efficacy of Three Toothpastes Using an in Situ Caries Model

NCT02751320 | Completed Results

• 1 other identifier: 202301
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• % 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

  Baseline upto 2 weeks

• Transverse Microradiography (TMR) Net Remineralization Change (ΔM) Value of Phytate (0% 0.452% and 0.85%) at 4 Weeks

  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

  Baseline upto 4 weeks

• Enamel Fluoride Uptake (EFU) of All Study Formulation Variables

  At Week 2

• Enamel Fluoride Uptake (EFU) of All Study Formulation Variables

  At Week 4

Study Arms (6)

Experimental Dentifrice1

EXPERIMENTAL

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.

Drug: 0.425 % w/w phytate,1150ppm F

Experimental Dentifrice 2

EXPERIMENTAL

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.

Drug: 0.85 % w/w phytate,1150ppm F

Experimental Dentifrice 3

EXPERIMENTAL

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.

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

Reference Product 1

PLACEBO COMPARATOR

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.

Other: 0 ppm F

Reference Product 2

ACTIVE COMPARATOR

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.

Drug: 1150ppm F

Reference Product 3

ACTIVE COMPARATOR

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.

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

Interventions

0.425 % w/w phytate,1150ppm F DRUG

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

Experimental Dentifrice1

0.85 % w/w phytate,1150ppm F DRUG

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

Experimental Dentifrice 2

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

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

Experimental Dentifrice 3

0 ppm F OTHER

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

Reference Product 1

1150ppm F DRUG

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

Reference Product 2

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

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

Reference Product 3

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Dental Caries

Interventions

Sodium Citrate

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Citric Acid; Citrates; Tricarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2016
• First Posted: April 26, 2016
• Study Start: February 1, 2016
• Primary Completion: July 1, 2016
• Study Completion: August 11, 2016
• Last Updated: October 13, 2017
• Results First Posted: October 13, 2017

Record last verified: 2017-07

Locations

US (1)