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Editorial

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A two-step stannous fluoride dentifrice and whitening gel sequence

     The dramatic growth and impact of tooth whitening worldwide has raised patients’ awareness of the appearance of their smile. The introduction of whitening strips in 2000 played an appreciable role, expanding access to an increasingly broad population. Some years later, the whitening concept increased to include more dentifrices developed for esthetic reasons.

     At the same time, gingival health is even more important over the long-term and the prevalence of gingivitis remains high. The currently recognized gold standard chemotherapeutic treatment, chlorhexidine, has several esthetic drawbacks that limit patient compliance, and consequently effectiveness. Recognizing the wide-spread need for an acceptable and efficacious gingival health therapy, in tandem with patients’ growing desire for whiter teeth, researchers designed a novel two-step system to meet both objectives.

     This special issue of the American Journal of Dentistry highlights important research findings on gingi-val health, tooth whitening and safety associated with use of a unique two-step hygiene sequence: stannous fluoride dentifrice followed by hydrogen peroxide whitening gel. The research comes from diverse clinical settings.

     This special issue of the American Journal of Dentistry represents one of the largest collections of clini-cal research on this two-stage protocol. The randomized controlled trials described herein support its significant gingival health and whitening outcomes. Such diverse testing, with respect to populations, sites and controls, provides important evidence of the merits of the two-step method.  As you will see, this novel sequence shatters the long standing paradigm of therapeutic efficacy and esthetic negatives.

     We hope you will find these papers interesting and educational. The Journal thanks Procter & Gamble, the manufacturer, for sponsoring this Special Issue.

 

 

Franklin García-Godoy, DDS, MS, PhD, PhD

Editor

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                                                                                                                         Special Issue Introduction

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Clinical evidence on a unique two-step stannous fluoride dentifrice and whitening gel sequence

 

Paul A. Sagel, bsche  &  Robert W. Gerlach, dds, mph

 

Abstract: Purpose: Recently, a unique two-step product was introduced that includes sequential use of a novel 0.454% stannous fluoride dentifrice followed by a 3% hydrogen peroxide whitening gel. The technology targeted advanced gingival health benefits plus esthetic benefits such as tooth whitening. The two-step sequence has unique brushing instructions to maximize the efficacy of each step; the stannous fluoride dentifrice is used for 1 minute of brushing followed by 1 minute of brushing with the hydrogen peroxide gel. This two-step sequence has been studied in numerous clinical trials over a series of years. This comprehensive program included different populations and sites, endpoints and time points, with responses measured versus different positive and negative research controls. A total of six clinical trials are reported herein. Outcomes from this research program demonstrate the significant gingival health efficacy of the two-step product, providing therapeutic efficacy comparable to chlorhexidine, and its positive impact on plaque, tooth stain and breath odor. (Am J Dent 2018;31:4A-6A).

 

 

 

 

 

 

*: Mr. Paul A. Sagel, The Procter & Gamble Company, 8700 Mason-Montgomery Road, Mason, OH 45040 USA. E-*: sagel.pa@pg.com

 

 

 

 

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                                                                                                                        Special Issue Article

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Initial evidence of two-step dentifrice/gel sequence effects on health: Outcomes from three randomized controlled trials

 

Robert W. Gerlach, dds, mph &  Paul A. Sagel, bsche

 

Abstract: Purpose: Health-related outcomes from three randomized controlled trials represented the initial research on the feasibility of novel, sequential oral hygiene with a stannous fluoride (SnF₂) dentifrice then hydrogen peroxide (H₂O₂) whitening gel. Methods: One crossover and two parallel clinical trials were conducted independently. Objectives varied, with individual studies assessing short, intermediate or longer-term outcomes from breath, dental plaque or gingivitis, respectively. Treatments were randomly assigned, and blinded test kits were dispensed containing either: 1) a two-step 0.454% SnF₂ dentifrice and then a 3% H₂O₂ whitening gel sequence and instructions specifying 1+1 minute sequential brushing (experimental); or 2) 0.76% sodium monofluorophosphate dentifrice (Colgate Cavity Protection) and instructions for twice daily use (control). Standard methods were used to measure efficacy (volatile sulfur compounds, plaque area coverage or gingival bleeding) and safety (clinical examination and interview), and to compare treatment responses. Results: Overall, 165 subjects participated in the three trials. Relative to baseline, only the experimental group exhibited significant (P< 0.05) improvements at initial and subsequent timepoints in each trial. Between-group comparisons showed significant (P< 0.05) 30-45% reductions in breath malodor (VSC), plaque (area%) and gingivitis (bleeding sites) favoring the experimental group. Adverse event occurrences were infrequent, mild in severity, and unrelated to dropout. (Am J Dent 2018;31:7A-12A).

 

 

*: Mr. Paul A. Sagel, The Procter & Gamble Company, 8700 Mason-Montgomery Road, Mason, OH 45040 USA. E-*: sagel.pa@pg.com

 

 

 

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                                                                                                                                 Special Issue Article

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Randomized controlled trial evaluating concurrent gingivitis and stain effects of a two-step dentifrice/gel sequence

 

 

Pejmon Amini, dds, Alborz Amini, bsc  &  Robert W. Gerlach, dds, mph

 

Abstract: Purpose: A randomized controlled trial was conducted to evaluate the clinical efficacy of a two-step dentifrice/whitening gel oral hygiene sequence on natural gingivitis and extrinsic stain. Methods: The population consisted of healthy adults with clinical evidence of gingivitis and extrinsic stain. Consent, demographic information and clinical measurements were collected, after which subjects were randomized to treatment. Eligible subjects were dispensed blinded test kits containing over-labeled two-step 0.454% SnF₂ dentifrice then 3% H₂O₂ whitening gel sequence or a regular 0.76% NaMFP dentifrice control (Colgate Cavity Protection), plus a regular soft manual toothbrush and instructions for use. Efficacy was assessed blind-to-treatment using the Gingivitis Bleeding Index (GBI) measured whole-mouth and the composite Lobene Stain Index (LSI) measured on the anterior dentition. Treatments were compared at Week 1 and Week 3 versus baseline for ΔGBI and ΔLSI using a two-sided 5% level of significance. Results: A total of 61 subjects with a mean (SD) age of 33.4 (12.0) years were enrolled. Overall baseline means (SD) were 0.16 (0.05) for GBI and 1.30 (0.94) for LSI. After 1 week, only the two-step 0.454% SnF₂ dentifrice then 3% H₂O₂ whitening gel sequence demonstrated significant (P< 0.0001) reductions in both gingivitis and stain. Adjusted means for the changes with the dentifrice/gel sequence and control were –0.055 and –0.001 for ΔGBI, and –0.619 and –0.095 for ΔLSI, with groups differing significantly (P< 0.0001) on gingivitis and stain improvement. Outcomes at Week 3 were generally similar, with groups differing on bleeding and stain. Treatments were generally well-tolerated. (Am J Dent 2018;31:13A-17A).

 

 

 

 

 

 

*: Dr. Pejmon Amini, Silverstone Research Group, 6707 West Charleston Blvd., Suite #4, Las Vegas, NV 89146 USA. E-*: pamini@silverstoneresearch.com

 

 

 

 

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                                                                                                             Special Issue Article

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Post-prophylaxis gingivitis prevention with two-step stannous fluoride dentifrice plus whitening gel sequence or chlorhexidine gluconate mouthrinse

 

Cristina Garcia-Godoy, dds, mph, ccrp,  James Rothrock, bs,  Nataliya Gurich, phd,  Mary Kay Anastasia, ba &  Robert W. Gerlach, dds, mph

 

Abstract: Purpose: To assess use of a two-step dentifrice/gel sequence versus chlorhexidine gluconate mouthrinse on gingivitis prevention after dental prophylaxis. Methods: A 12-week, randomized controlled trial was conducted to compare the effectiveness and safety of a two-step dentifrice/gel sequence to a positive control in healthy adults with established gingivitis. After informed consent, gingivitis and stain levels were assessed by clinical examination. Eligible subjects received a dental prophylaxis and were randomly assigned to twice daily unsupervised use of either (1) two-step oral hygiene sequence: 0.454% stannous fluoride dentifrice followed by 3.0% hydrogen peroxide whitening gel for the test group; or (2) 0.12% chlorhexidine gluconate oral rinse and 0.76% sodium monofluorophosphate dentifrice for the control group. Clinical measurements of gingivitis bleeding sites and tooth stain area/intensity were collected after 4, 8 and 12 weeks use, while safety was assessed via clinical examination and oral status interview of the subjects. Results: A total of 44 subjects were enrolled and 35 completed the 12-week study. At baseline, bleeding sites ranged from 10-33. After prophylaxis and assigned treatment, both groups exhibited significant (P£ 0.0001) reductions in bleeding sites. Responses were directionally better in the two-step sequence at all post-baseline timepoints, with groups differing significantly (P < 0.05) at Week 8. Tooth stain measurements demonstrated that the two-step dentifrice/gel sequence did not contribute to any significant (P> 0.13) stain accumulation. In contrast, stain accumulation was evident (P< 0.003) in the chlorhexidine group beginning at the Week 4 visit. Adverse events were more common in the positive control, and contributed to early termination. (Am J Dent 2018;31:18A-23A).

 

 

 

 

 

*: Dr. Cristina Garcia-Godoy, College of Dental Medicine, Nova Southeastern University, 3200 South University Drive, Ft. Lauderdale FL 33314, USA. E-*: cgarciag@nova.edu

 

 

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Safety and effectiveness of a two-step dentifrice/gel sequence with medication-associated hyposalivation: A randomized controlled trial in a vulnerable population

 

Mabi Singh, dmd, ms, Athena Papas, dmd, phd  &  Robert W. Gerlach, dds, mph

 

Abstract: Purpose: A randomized controlled trial was conducted to evaluate the safety and effectiveness of a two-step dentifrice/gel oral hygiene sequence in a vulnerable population. Methods: Prior to the research, institutional review was obtained for the protocol, consent and advertising. The study targeted adults with medication-associated xerostomia, because of the plaque accumulation and possible oral safety risks seen in this population. Eligible subjects with a medication history and measured hyposalivation were randomly assigned to one of two oral hygiene groups: (1) a two-step 0.454% SnF₂ dentifrice and 3% H₂O₂ gel sequence or (2) a regular anticavity toothpaste control. Test products were dispensed with a regular manual brush in blinded over-labeled kits with usage instructions. Subjects were evaluated at baseline and after 2 and 6 weeks of test product use. Safety was assessed as adverse events from clinical examination and interview. Digital plaque image analysis of the anterior facial teeth measured fluorescein-disclosed daytime plaque levels, and unstimulated saliva was collected over a 5-minute period in pre-weighed vials. Results: A total of 49 subjects ranging from 31-80 years of age (53% female) were enrolled, and 45 completed Week 6. Only the two-step dentifrice and gel sequence differed significantly (P< 0.005) from baseline on daytime plaque coverage, and salivary flow increased significantly (P= 0.033) in that group as well. Between-group comparisons for daytime plaque favored the two-step sequence with 41-46% improvements in plaque control. At Week 6, adjusted daytime plaque means (SE) were 5.9 (0.7) and 10.0 (1.1) for the two-step and control groups, respectively (P< 0.004). Adverse events were mild in severity, groups differed significantly (P= 0.02) on occurrence, and events did not contribute to dropout. (Am J Dent 2018;31:24A-28A).

 

 

 

 

*: Dr. Mabi Singh, Associate Professor, Tufts University School of Dental Medicine, 1 Kneeland Street, Boston, MA 02111 USA.  E-*:  Mabi_L.Singh@tufts.edu