Study No. XER-EPTG-2015-002
Final Report 2 February 2016
ABSTRACT
Objective: The purpose of this two-period crossover study was to evaluate the safety and
efficacy of Enamelon® Preventive Treatment Gel in relieving subject-perceived dry mouth
symptoms in a dry mouth population after 14 days of use, compared to Biotene® Oral Balance,
Dry Mouth Moisturizing Gel.
Methods: This six-week, single-blind, randomized, two-period crossover clinical study consisted
of a screening visit followed by a 7-day washout period, a 14-day treatment period (Period 1), a
7-day washout period, and a second 14-day treatment period (Period 2). Subjects assigned to
Enamelon® Preventive Treatment Gel (EPTG) in Period 1 used the positive control, a
commercially available dry mouth gel product Biotene® Oral Balance, Dry Mouth Moisturizing
Gel (BOBG), in Period 2; subjects assigned to the BOBG in Period 1 received EPTG in Period 2.
Qualified subjects were ≥ 18 years of age with self-reported dry mouth symptoms, according to
at least one positive response on the Dry Mouth Inventory. Subjects used the test materials once
daily during each 14-day test period. On Days 1, 8 and 15 of each test period, subjects received
an oral soft and hard tissue exam. Efficacy of EPTG to relieve dry mouth symptoms after 7 and
14 days of treatment was based on a Product Performance Questionnaire (PPQ).
Results: There were no treatment related adverse events reported in this study and both products
were well-tolerated by the subjects. As expected, BOBG, the positive control, significantly
improved dry mouth symptoms, thus validating the study. EPTG also provided significant relief
of several dry mouth symptoms. Compared with subjects’ ratings of their usual dry mouth
remedies, ratings of principal dry mouth symptoms for both BOBG and EPTG were statistically
significantly better at both Days 8 and 15. Following 7 and 14 days of use, BOBG was
statistically significantly different from EPTG in relieving many of the principal dry mouth
symptoms.
Conclusion: This study shows that EPTG was beneficial in the management of subjectperceived dry mouth 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. EPTG also soothes and moistens dry
oral soft tissue and is non-irritating to dry mouth tissues.
Page 3 of 207
1
TITLE PAGE
TITLE OF STUDY:
Efficacy of Enamelon® Preventive Treatment Gel in a Self-Reported Dry
Mouth Population
NAME OF FINISHED
PRODUCT:
Enamelon® Preventive Treatment Gel
NAME OF ACTIVE
INGREDIENT:
Sponsor:
Stannous Fluoride
Protocol No.:
XER-EPTG-2015-002
Study dates:
22 September 2015 – 3 November 2015
Investigators:
Jeffrey Milleman, DDS, MPA
Kimberly Milleman, RDH, BS, MS
Salus Research, Inc.
1220 Medical Park Drive, Building #4
Fort Wayne, IN 46825
Premier Dental Products Company
1710 Romano Drive
Plymouth Meeting, Pennsylvania, 19462, USA
GCP Statement:
This study was performed in compliance with ICH Good Clinical
Practice (GCP) including the archiving of essential documents.
Date of report:
2 February 2016