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

NCT04155658 | Completed

• 1 other identifier: ORL-IST-3324
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Enamel Caries

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in integrated mineral loss ∆∆Z (enamel specimen type C)

  Baseline to 4 weeks

Study Arms (3)

Experimental SMFP Toothpaste

EXPERIMENTAL

Toothpaste containing 1450ppm SMFP with additional calcium and phosphate

Other: Experimental Toothpaste containing 1450ppm SMFP

SMFP Toothpaste

ACTIVE COMPARATOR

Toothpaste containing 1450ppm SMFP

Other: Toothpaste containing 1450ppm SMFP

Negative control toothpaste

PLACEBO COMPARATOR

Toothpaste with no fluoride

Other: Toothpaste with no fluoride

Interventions

Experimental Toothpaste containing 1450ppm SMFP OTHER

Experimental Toothpaste containing 1450ppm SMFP

Experimental SMFP Toothpaste

Toothpaste containing 1450ppm SMFP OTHER

Toothpaste containing 1450ppm SMFP

SMFP Toothpaste

Toothpaste with no fluoride OTHER

Toothpaste with no fluoride

Negative control toothpaste

Eligibility Criteria

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

You may qualify if:

• 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.
• Have completed and been accepted into the Oral Health Research Institute's screening for partial denture panel (#110007150).
• 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.
• 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.).
• 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

You may not qualify if:

• Currently pregnant, intending to become pregnant during the trial period or breast-feeding.
• Have a history of significant adverse effects following use of oral hygiene products such as toothpastes and mouth rinses.
• Have any allergy to ingredients in the trial toothpaste products.
• Currently be taking antibiotics or have taken antibiotics in the two weeks prior to the beginning the first treatment.
• 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.
• Currently taking or have ever taken a bisphosphonate drug (i.e. Fosamax®, Actonel®, Boniva®, Reclast®, or Zometa®) for treatment of osteoporosis.
• 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.
• Participation in another clinical trial/study within 30 days preceding the present trial/study.

Sponsors & Collaborators

• Unilever R&D: lead
• Indiana University: collaborator

Study Sites (1)

Oral Health Research Institute, Indiana University

Indianapolis, Indiana, 46202-2876, United States

Location

MeSH Terms

Interventions

Toothpastes

Intervention Hierarchy (Ancestors)

Dentifrices; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Domenick T Zero, DDS, MS

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2019
• First Posted: November 7, 2019
• Study Start: November 25, 2019
• Primary Completion: April 30, 2020
• Study Completion: April 30, 2020
• Last Updated: May 18, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)