Phase 3 N=62 Randomized Triple-blind Treatment

Effect of Fluoride in a Dentifrice on Remineralization of Erosive Lesions

Enamel Erosion

Bottom Line

View on ClinicalTrials.gov: NCT01641237 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2013

Primary outcome: Primary: Percentage Surface Microhardness Recovery (%SMHR) Dose Response Relationship — 30.89; 28.71; 25.28; 21.03 %SMHR — p=<0.0001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: sodium fluoride (Drug); no added fluoride in a silica base (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: GlaxoSmithKline
Primary completion: May 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage Surface Microhardness Recovery (%SMHR) Dose Response Relationship	30.89; 28.71; 25.28; 21.03	<0.0001 sig
SECONDARY %SMHR	30.9; 28.7; 25.3; 21.0	0.1898
SECONDARY Percentage Relative Erosion Resistance	-38.83; -39.75; -50.40; -71.21	<0.0001 sig
SECONDARY Enamel Fluoride Uptake (Corrected Data)	3.13; 3.07; 2.09; 1.47	<0.0001 sig

Summary

The proposed study will evaluate the performance of fluoride delivered from a new dentifrice formulation without potassium nitrate. It will also evaluate the dose-response to fluoride by testing four dentifrices covering a range of sodium fluoride concentration.

Eligibility Criteria

Inclusion Criteria

intact maxillary dental arch suitable to retain a palatal appliance, an intact mandibular dental arch and a stimulated/unstimulated saliva flow rate of ≥ 0.8 milliliter/minute (ml/min) and ≥ 0.2 ml/min respectively.

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Data sourced from ClinicalTrials.gov (NCT01641237). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.