Evaluation of Efficacy of Sodium Monofluorophosphate (SMPF) Toothpastes on Enamel Lesion Remineralisation

An in Situ Clinical Trial to Evaluate the Efficacy of a Calcium and Phosphate Enriched Sodium Monofluorophosphate Toothpaste on Enamel Lesion Remineralisation

Double-blind, randomized, 3 group in situ study to assess effect of three toothpastes on enamel remineralization, as measured by change in integrated mineral loss (∆∆Z). The study will examine the efficacy of an experimental sodium monofluorophosphate (SMFP) toothpaste, a standard SMFP toothpaste and a negative control toothpaste with no fluoride.

Study Overview

• Status: Completed
• Conditions: Enamel Caries
• Intervention / Treatment: Other: Experimental Toothpaste containing 1450ppm SMFP; Other: Toothpaste containing 1450ppm SMFP; Other: Toothpaste with no fluoride

Detailed Description

Double-blind, randomized, 3 group, in situ enamel remineralisation study. This study will accept up to 60 adult subjects who meet the inclusion/exclusion criteria in anticipation that at least 50 subjects will complete the study. All 60 subjects will have two human enamel specimens (one enamel specimen type C and one enamel specimen type N) placed in their partial denture for analysis by transverse microradiography (TMR) and of those sixty subjects, a subset will have an additional two enamel specimens (type N) placed in their partial denture for TMR measurement. All enamel specimens will have been partially demineralized using lactic acid in the laboratory prior to placement in subjects' dentures.

Subjects will receive a dental prophylaxis at the start of the trial and then brush their teeth with a fluoride-free toothpaste for the following 2 to 3 days. For the washout phase between each crossover period, subjects will return to brushing with their regular toothpaste for 4 to 5 days and then receive a dental prophylaxis and brush their teeth with a fluoride-free toothpaste for the 2 to 3 days before the next test period.

During each test period, subjects will be asked to brush with their allocated toothpaste at home twice daily for 4 weeks taking care to not brush the enamel specimens. The brushing procedure will be performed at home each morning following breakfast and right before going to bed on each evening. Subjects must wear their partial denture for 24 hours a day during the test phase.

At final visit of each test period, subjects will be instructed to brush their teeth with the randomly assigned trial toothpaste. Enamel specimens will be removed from denture and transferred to analyst for laboratory analyses.

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202-2876
      • Oral Health Research Institute, Indiana University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 83 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Key Inclusion Criteria:

1. Be wearing a removable mandibular partial denture that fits comfortably enough to wear 24 hours a day and willing to have their partial denture modified to accommodate the enamel test specimens.
2. Have completed and been accepted into the Oral Health Research Institute's screening for partial denture panel (#110007150).
3. Have no current active caries or periodontal disease that may compromise the trial or health of the person. Persons exhibiting localized periodontal conditions who, in the opinion of the trial dentist, will not be negatively affected by participation in intra-oral studies may be accepted. Persons with caries may participate if the carious lesions have been restored prior to beginning the first treatment.
4. Be willing to comply with all subjects' responsibilities (be willing and capable of wearing their removable partial dentures 24 hours per day during the treatment periods, attend appointments, follow brushing instructions, use non zinc adhesive in upper denture only etc.).
5. Have an unstimulated salivary flow rate of at least 0.2 ml per minute as determined by a five-minute salivary flow test at screening and a stimulated salivary flow rate of at least 0.8 ml per minute as determined by a two-minute stimulated (gum base) salivary flow test at screening

Key Exclusion Criteria:

1. Currently pregnant, intending to become pregnant during the trial period or breast-feeding.
2. Have a history of significant adverse effects following use of oral hygiene products such as toothpastes and mouth rinses.
3. Have any allergy to ingredients in the trial toothpaste products.
4. Currently be taking antibiotics or have taken antibiotics in the two weeks prior to the beginning the first treatment.
5. Have factors which could contraindicate their participation, such as any condition requiring the need for antibiotic premedication prior to a dental treatment, a condition requiring the need for long-term antibiotic use, blood thinning medications* that prohibit the safe conduct of a dental cleaning* or previous use of the weight loss medications Fen Phen® or Redux®. *Note: Subjects who are taking blood thinners in which written verification is obtained from their physician indicating their PT/INR levels (anti-coagulation blood levels) are at an acceptable level to avoid serious complications, such as bleeding during dental cleaning, may be accepted into the trial.
6. Currently taking or have ever taken a bisphosphonate drug (i.e. Fosamax®, Actonel®, Boniva®, Reclast®, or Zometa®) for treatment of osteoporosis.
7. Currently taking fluoride supplements, required to use a fluoride mouth rinse or have received a professional fluoride treatment in the two weeks preceding specimen placement.
8. Participation in another clinical trial/study within 30 days preceding the present trial/study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental SMFP Toothpaste; Toothpaste containing 1450ppm SMFP with additional calcium and phosphate	Other: Experimental Toothpaste containing 1450ppm SMFP; Experimental Toothpaste containing 1450ppm SMFP
Active Comparator: SMFP Toothpaste; Toothpaste containing 1450ppm SMFP	Other: Toothpaste containing 1450ppm SMFP; Toothpaste containing 1450ppm SMFP
Placebo Comparator: Negative control toothpaste; Toothpaste with no fluoride	Other: Toothpaste with no fluoride; Toothpaste with no fluoride

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in integrated mineral loss from baseline ∆∆Z (enamel specimen type N)	Calculation of Integrated Mineral Loss ∆Z = [(lesion depth x 87) - area under the curve] where 'area under the curve' relates volume % mineral at distances from the enamel specimen surface with respect to enamel section thickness, measured using transverse microradiography (TMR)	Baseline to 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in integrated mineral loss ∆∆Z (enamel specimen type C)	Calculation of Integrated Mineral Loss ∆Z = [(lesion depth x 87) - area under the curve] where 'area under the curve' relates volume % mineral at distances from the enamel specimen surface with respect to enamel section thickness, measured using transverse microradiography (TMR)	Baseline to 4 weeks

Collaborators and Investigators

• Sponsor: Unilever R&D
• Collaborators: Indiana University

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2019
• Primary Completion (Actual): April 30, 2020
• Study Completion (Actual): April 30, 2020

Study Registration Dates

• First Submitted: November 5, 2019
• First Submitted That Met QC Criteria: November 5, 2019
• First Posted (Actual): November 7, 2019

Study Record Updates

• Last Update Posted (Actual): May 18, 2020
• Last Update Submitted That Met QC Criteria: May 15, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Protective Agents; Cariostatic Agents; Fluorides
• Other Study ID Numbers: ORL-IST-3324

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No