Subjective Assessment of Enamelon® Preventive Treatment Gel in a Self-Reported Dry-Mouth Population.
BACKGROUND
The efficacy of stannous fluoride toothpastes is well established for reducing caries, plaque, and gingivitis and relieving the discomfort of dentin hypersensitivity. Management of dry mouth may include relief remedies in addition to usual oral hygiene methods to maintain oral health and improve quality of life. This 6-week, single-blind, randomized, two-period crossover clinical study was designed to evaluate the oral tolerance and potential of Enamelon® Preventive Treatment Gel (EPTG), with 0.4% stannous fluoride, to relieve subject-perceived dry-mouth symptoms in a self-reported dry-mouth population, after 14 days of use, compared to a marketed over-the-counter (OTC) artificial saliva gel product (Biotene® Oral Balance Gel [BOBG]).


METHODS
Following a 7-day washout period, 52 qualified subjects with self-reported dry-mouth symptoms received EPTG or BOBG for once-daily use for 14 days. All subjects brushed each morning and evening with a standard fluoride toothpaste (Sensodyne® ProNamel). Each evening and following brushing with the Sensodyne ProNamel, subjects used their assigned gel product (EPTG or BOBG) as directed. On Days 1, 8, and 15, subjects received an oral examination and assessed relief of dry-mouth symptoms using a product-performance questionnaire (PPQ). Procedures were repeated with the alternate product for another 14-day period, following a 7-day washout. Data for each efficacy endpoint were analyzed using crossover ANOVA model.


RESULTS
No treatment-related adverse events were reported in this study, and both products were well tolerated by the subjects. Compared to pre-study ratings of usual dry-mouth remedies, both BOBG and EPTG significantly reduced dry-mouth symptoms following 14 days of use. BOBG was statistically significantly better than EPTG in relieving many of the principal dry-mouth symptoms such as providing immediate relief, having an immediate moisturizing and immediate lubricating effect, feeling comfortable in the mouth, soothing the mouth, effectively lubricating the mouth, and protecting the mouth from drying out (P < .05). Compared with subjects' ratings of their usual dry-mouth remedies, EPTG also provided relief of several dry-mouth symptoms at both Days 8 and 15 (P < .05).


CONCLUSIONS
Based on subjective measures of dry mouth and compared with pre-study ratings of usual remedies, subjects perceived that EPTG helped to manage symptoms such as relieving the discomfort of dry mouth, immediately moisturizing and lubricating, effectively lubricating, protecting from drying out, and providing long-lasting moisturization and long-lasting lubrication, and was not irritating to dry-mouth tissues. BOBG, the positive control, was significantly better than EPTG in relieving dry-mouth symptoms over a 2-week period and was not irritating.


CONCLUSIONS
Patients with dry-mouth symptoms may benefit from daily use of a non-irritating, OTC fluoride preventive treatment gel product to relieve symptoms while also reducing the risks of developing dental caries, demineralization, dentin hypersensitivity, and gingivitis.
Director, Clinical Operations, Salus Research Inc., Fort Wayne, Indiana.
Jeffery L
JL
Milleman
Director, Compliance Specialist, and Examiner, Salus Research Inc., Fort Wayne, Indiana.
Kimberly R
KR
Milleman
President, SLS Clinical Research Consulting, LLC, Pine Brook, NJ.
Sylvia L
SL
Santos
President, Howard M. Proskin and Associates, Rochester, New York.
Howard M
HM
Proskin
Senior Clinical Coordinator, Salus Research Inc., Fort Wayne, Indiana.
Kirstin K
KK
Battershell
Director of Clinical Affairs, Premier Dental Products Co., Plymouth Meeting, Pennsylvania.
James C
JC
DiMarino
D000328:Adult; D002130:Calcium Phosphates / Q000627:therapeutic use*; D018592:Cross-Over Studies; D004338:Drug Combinations; D005260:Female; D005459:Fluorides / Q000627:therapeutic use*; D005782:Gels / Q000627:therapeutic use; D005949:Glucose Oxidase / Q000627:therapeutic use; D006801:Humans; D007784:Lactoperoxidase / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D009113:Muramidase / Q000627:therapeutic use; D057566:Self Report; D016037:Single-Blind Method; D014100:Toothpastes / Q000627:therapeutic use*; D016896:Treatment Outcome; D014987:Xerostomia / Q000188:drug therapy*
C111669:Biotene; D002130:Calcium Phosphates; D004338:Drug Combinations; C118793:Enamelon; D005782:Gels; D014100:Toothpastes; D005949:Glucose Oxidase; D007784:Lactoperoxidase; D009113:Muramidase; D005459:Fluorides