An Erosion Study to Investigate the Efficacy of an Experimental Dentifrice to Remineralize Enamel

Not Applicable

Completed

• Conditions: Tooth Erosion
• Interventions: Drug: Experimental Dentifrice; Drug: Placebo Control Dentifrice; Drug: Reference Dentifrice

• Registration Number: NCT06242444
• Lead Sponsor: HALEON

Brief Summary

The purpose of this study is to investigate the ability of an experimental dentifrice containing 1150 parts per million (ppm) fluoride to remineralize acid-softened dental enamel and help prevent further demineralization compared to a 0 ppm fluoride placebo dentifrice and a marketed, fluoride-containing dentifrice (Reference Dentifrice).

Detailed Description

This will be a randomized, controlled, single center, single-blind, 3 period, 3 treatment, cross-over, in situ design study. Previously demineralized bovine enamel specimens will be placed intra orally using a palatal appliance and the remineralizing performance of the experimental, reference and placebo dentifrices will be evaluated at 4 and 12 hours post toothbrushing, based on surface micro hardness measurements of the bovine enamel specimens. At each treatment visit, once the palatal the appliance is fitted in the mouth, a five minute equilibration period will ensue following which each participant will brush their teeth with their assigned product. Participants will remove the appliance for 30 minutes at 4 and 8.5 hours post brushing and will remove and store the appliance 13 hours post brushing (12 hours intraoral exposure). Sufficient participants will be screened to randomize approximately 33 participants to study treatment to ensure approximately 30 participants complete the study.

Study Timeline

• Study First Submitted: 2024-01-29
• Study First Submitted QC: 2024-01-29
• Study First Posted: 2024-02-05
• Study Start: 2024-02-26
• Status Verified: 2024-05
• Primary Completion: 2024-05-07
• Study Completion: 2024-05-07
• Last Update Submitted: 2024-05-14
• Last Update Posted: 2024-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

• Participant provision of a signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed.

• Participant is of either sex and any gender who, at the time of screening, is between the ages of 18-65 years, inclusive.

• Participant is willing and able to comply with scheduled visits, and other study procedures and restrictions.

• Participant is in good general and mental health with, in the opinion of the investigator or medically qualified designee, no clinically significant or relevant abnormalities in medical history or upon oral examination, or condition, that would impact the participant's safety, wellbeing or the outcome of the study, if they were to participate in the study, or affect the individual's ability to understand and follow study procedures and requirements.

• Participant with generally good oral health that fulfil all of the following:

  1. Having an unstimulated salivary flow rate of at least 0.2 milliliter per minute (mL/minute) and a stimulated salivary flow rate of at least 0.8 mL/minute.
  2. Having a maxillary dental arch suitable for the retention of the palatal appliance.
  3. Having no lesions of the oral cavity that could interfere with the study evaluations.

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Exclusion Criteria

• Participant who is an employee of the investigational site, either directly involved in the conduct of the study or a member of their immediate family; or an employee of the investigational site otherwise supervised by the investigator; or, a Haleon employee directly involved in the conduct of the study or a member of their immediate family (employees of the study site and associated academic institutes who are not directly involved in the conduct of the study are eligible to be considered as participants.)
• Participant who has participated in other studies (including non-medicinal studies) involving investigational product(s) within 30 days prior to study entry and/or during study participation.
• Participant with, in the opinion of the investigator or medically qualified designee, an acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator or medically qualified designee, would make the participant inappropriate for entry into this study.
• Participant who is pregnant (self-reported) or intending to become pregnant over the duration of the study or who is breastfeeding.
• Participant with known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
• A participant who, in the opinion of the investigator or medically qualified designee, can't comply with study requirements or who should not participate in the study for other reasons.
• Participant unwilling or unable to comply with the Lifestyle Considerations described in this protocol.
• Participant taking medication that may interfere significantly with the saliva flow in the judgment of the investigator. Should new medications that may interfere with the saliva flow be added, a second salivary flow test will be performed.
• Participant with any condition that would impact on their safety or wellbeing or affect their ability to understand and follow study procedures and requirements.
• Participant with any sign of grossly carious lesions (active), moderate or severe periodontal conditions, or severe tooth wear. Participant presenting at screening with minor caries may continue in the study if their carious lesions are repaired prior to the first treatment visit of the study.
• Participant who wears an oral piercing or oral appliance or orthodontia (besides participants wearing permanent lower retainers, which are eligible).
• Participant who has previously been enrolled in this study.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Experimental Dentifrice	Experimental Dentifrice	Participants will brush the buccal surfaces of their natural teeth using 1.5+/- 0.1 grams (g) of the experimental dentifrice containing 1150 ppm fluoride and 5 percent (%) potassium nitrate (KNO3) for 25 timed seconds and then swish the resulting dentifrice slurry around the mouth, without further brushing, for a timed period of 95 seconds. Participants will use the dentifrice under supervision of the study staff while the intraoral appliance is in place in Treatment Periods 1 to 3. There will be a washout period of a minimum of 3 days prior to each treatment during which the participants will use their own dentifrice for at least one day, and a 0 ppm fluoride washout dentifrice for two days.
Placebo Control Dentifrice	Placebo Control Dentifrice	Participants will brush the buccal surfaces of their natural teeth using 1.5+/- 0.1 g of the placebo dentifrice containing 0 ppm fluoride and 5% KNO3 for 25 timed seconds and then swish the resulting dentifrice slurry around the mouth, without further brushing, for a timed period of 95 seconds. Participants will use the dentifrice under supervision of the study staff while the intraoral appliance is in place in Treatment Periods 1 to 3. There will be a washout period of a minimum of 3 days prior to each treatment during which the participants will use their own dentifrice for at least one day, and a 0 ppm fluoride washout dentifrice for two days.
Reference Dentifrice	Reference Dentifrice	Participants will brush the buccal surfaces of their natural teeth using 1.5+/- 0.1 g of the reference dentifrice containing 1100 ppm fluoride as stannous fluoride (SnF2) for 25 timed seconds and then swish the resulting dentifrice slurry around the mouth, without further brushing, for a timed period of 95 seconds. Participants will use the dentifrice under supervision of the study staff while the intraoral appliance is in place in Treatment Periods 1 to 3. There will be a washout period of a minimum of 3 days prior to each treatment during which the participants will use their own dentifrice for at least one day, and a 0 ppm fluoride washout dentifrice for two days.

Primary Outcome Measures

Name	Time	Method
Percent Surface Microhardness Recovery (%SMHR) at 4 Hours (Experimental Dentifrice Versus (vs.) Placebo Dentifrice)	At 4 hours of intra-oral exposure	Surface microhardness (SMH) test will be used to evaluate changes in the mineral content of enamel specimens and to calculate %SMHR. The %SMHR will be derived as \[(E1-R)/(E1-B)\] \* 100 where: B = indentation length (micrometre \[μm\]) of sound enamel at baseline, E1 = indentation length (μm) after first erosive challenge, R = indentation length (μm) after 4 hours in situ remineralization.

Secondary Outcome Measures

Name	Time	Method
Percent Relative Erosion Resistance (%RER) at 4 hours (Experimental Dentifrice vs. Placebo Dentifrice)	At 4 hours of intra-oral exposure	SMH test will be used to evaluate changes in the mineral content of enamel specimens and to calculate %RER. The %RER will be derived as \[(E1-E2)/(E1-B)\] \* 100 where: B = indentation length (μm) of sound enamel at baseline, E1 = indentation length (μm) after first erosive challenge, E2 = indentation length (μm) after second erosive challenge.
%SMHR at 4 Hours (Experimental Dentifrice vs. Reference Dentifrice)	At 4 hours of intra-oral exposure	SMH test will be used to evaluate changes in the mineral content of enamel specimens and to calculate %SMHR. The %SMHR will be derived as \[(E1-R)/(E1-B)\] \* 100 where: B = indentation length (μm) of sound enamel at baseline, E1 = indentation length (μm) after first erosive challenge, R = indentation length (μm) after 4 hours in situ remineralization.
%SMHR at 12 Hours	At 12 hours of intra-oral exposure	SMH test will be used to evaluate changes in the mineral content of enamel specimens and to calculate %SMHR. The %SMHR will be derived as \[(E1-R)/(E1-B)\] \* 100 where: B = indentation length (μm) of sound enamel at baseline, E1 = indentation length (μm) after first erosive challenge, R = indentation length (μm) after 12 hours in situ remineralization.
%RER at 4 hours (Experimental Dentifrice vs. Reference Dentifrice)	At 4 hours of intra-oral exposure	SMH test will be used to evaluate changes in the mineral content of enamel specimens and to calculate %RER. The %RER will be derived as \[(E1-E2)/(E1-B)\] \* 100 where: B = indentation length (μm) of sound enamel at baseline, E1 = indentation length (μm) after first erosive challenge, E2 = indentation length (μm) after second erosive challenge.
%RER at 12 hours	At 12 hours of intra-oral exposure	SMH test will be used to evaluate changes in the mineral content of enamel specimens and to calculate %RER. The %RER will be derived as \[(E1-E2)/(E1-B)\] \* 100 where: B = indentation length (μm) of sound enamel at baseline, E1 = indentation length (μm) after first erosive challenge, E2 = indentation length (μm) after second erosive challenge.
Enamel Fluoride Uptake (EFU) at 4 and 12 hours	At 4 and 12 hours of intra-oral exposure	The incorporation of fluoride into the enamel specimens will be assessed by EFU measurements using microdrill enamel biopsies. The mean across specimens relating to a specific timepoint (4 or 12 hours) will be derived. The natural log of this mean will be used to represent the visit level EFU.
Acid Resistance Ratio (ARR) at 4 and 12 hours	At 4 and 12 hours of intra-oral exposure	SMH test will be used to evaluate changes in the mineral content of enamel specimens and to calculate ARR. The ARR will be derived as 1 - \[(E2-R)/(E1-B)\] where: B = indentation length (μm) of sound enamel at baseline, E1 = indentation length (μm) after first erosive challenge, E2 = indentation length (μm) after second erosive challenge, R = indentation length (μm) after 4 and 12 hours in situ remineralization.
%SMHR at 4 and 12 hours (Reference Dentifrice vs Placebo Dentifrice)	At 4 and 12 hours of intra-oral exposure	SMH test will be used to evaluate changes in the mineral content of enamel specimens and to calculate %SMHR. The %SMHR will be derived as \[(E1-R)/(E1-B)\] \* 100 where: B = indentation length (μm) of sound enamel at baseline, E1 = indentation length (μm) after first erosive challenge, R = indentation length (μm) after 4 and 12 hours in situ remineralization.
%RER at 4 and 12 hours (Reference Dentifrice vs Placebo Dentifrice)	At 4 and 12 hours of intra-oral exposure	SMH test will be used to evaluate changes in the mineral content of enamel specimens and to calculate %RER. The %RER will be derived as \[(E1-E2)/(E1-B)\] \* 100 where: B = indentation length (μm) of sound enamel at baseline, E1 = indentation length (μm) after first erosive challenge, E2 = indentation length (μm) after second erosive challenge.
EFU at 4 and 12 hours (Reference Dentifrice vs Placebo Dentifrice)	At 4 and 12 hours of intra-oral exposure	The incorporation of fluoride into the enamel specimens will be assessed by EFU measurements using microdrill enamel biopsies. The mean across specimens relating to a specific timepoint (4 or 12 hours) will be derived. The natural log of this mean will be used to represent the visit level EFU.
ARR at 4 and 12 hours (Reference Dentifrice vs Placebo Dentifrice)	At 4 and 12 hours of intra-oral exposure	SMH test will be used to evaluate changes in the mineral content of enamel specimens and to calculate ARR. The ARR will be derived as 1 - \[(E2-R)/(E1-B)\] where: B = indentation length (μm) of sound enamel at baseline, E1 = indentation length (μm) after first erosive challenge, E2 = indentation length (μm) after second erosive challenge, R = indentation length (μm) after 4 and 12 hours in situ remineralization.

Trial Locations

Locations (1)

Oral Health Research Institute; 🇺🇸 Indianapolis, Indiana, United States