The Clinical Evidence Behind ASPIRA

In short: The herbal formulation used in ASPIRA tablets has been evaluated in published, peer-reviewed research by Sterer and colleagues. A randomized controlled trial in 40 people, published in the Journal of Breath Research in 2013, found that the herbal mucoadhesive tablet significantly reduced breath odor scores and volatile sulfur compound levels compared with a placebo tablet, measured a full day after use. An earlier study of 56 volunteers, published in the Journal of Dentistry in 2008, reported significant reductions in both odor scores and volatile sulfur compounds. We are not aware of another breath-freshening tablet whose formulation has been evaluated in a published randomized controlled trial indexed in PubMed.

ASPIRA is a cosmetic breath-freshening product. It is not a drug, not a dietary supplement and not a medical device, and nothing on this page is a claim to treat or prevent any disease.

What causes bad breath, and what the studies measured

Most bad breath originates in the mouth rather than the stomach. Bacteria break down proteins in saliva and on the tongue, and the by-products include volatile sulfur compounds — hydrogen sulfide, methyl mercaptan and dimethyl sulfide. These gases are what people actually smell. Because they can be measured directly, volatile sulfur compounds are the standard objective endpoint in oral malodor research.

The studies below used three kinds of measurement together:

  • Odor judge scores. Two trained assessors rated breath odor on a standard scale. This is the accepted reference method in halitosis research, because human perception is ultimately what matters.
  • Volatile sulfur compound levels. Measured with a sulfide monitor (Halimeter), giving an objective reading independent of human judgement.
  • Salivary β-galactosidase activity. An enzyme assay that reflects the bacterial activity driving odor production.

Study 1: The randomized controlled trial (2013)

Published in
Journal of Breath Research, 2013;7(2):026004. PMID 23519054.
Design
Randomized, placebo-controlled trial with three parallel arms: the herbal mucoadhesive tablet, a placebo mucoadhesive tablet, and a commercial mouthwash.
Participants
40 healthy young adults presenting with oral malodor (mean age 25.8 years, 19 female).
Protocol
After baseline measurements, participants used their assigned product in the evening of the same day and the following morning. Follow-up measurements were taken the next afternoon - the design deliberately tested whether the effect lasted through a full day rather than for a few minutes.
Results versus placebo
Odor judge scores were significantly reduced (p = 0.004). Volatile sulfur compound levels were significantly reduced (p = 0.002). Salivary β-galactosidase activity was significantly reduced (p = 0.02). The mean odor judge score in the herbal tablet group was 1.7 on the scale used in the study.

In the authors' own words, the results “demonstrate the efficacy of the herbal formulation delivered using a mucoadhesive tablet” over the course of a day. That is the researchers' conclusion about the formulation they tested, quoted here as published.

Study 2: The earlier tablet study (2008)

Published in
Journal of Dentistry, 2008;36(7):535–539. PMID 18468761.
Design
Palatal adhesive tablets were prepared with different test ingredients - the herbal formulation, zinc, or chlorhexidine - alongside a placebo tablet containing none of them.
Participants
56 healthy young volunteers.
Results
The herbal tablet significantly reduced odor judge scores (p < 0.001) and volatile sulfur compound levels (p = 0.013).

This study established that the effect came from the herbal formulation itself rather than from the tablet: the same delivery format without the botanicals did not produce the same result.

Study 3: How the botanicals were selected (2006)

Published in
Quintessence International, 2006;37(8):653–658. PMID 16922026.
Design
Laboratory study using a salivary incubation model. Nine natural medicinals - echinacea, propolis, elder, mastic gum, marigold, sage, lavender, thyme and chamomile - were tested for their effect on salivary protein putrefaction and malodor production.
Results
All of the tested botanicals produced some reduction in malodor production from incubated whole saliva. Echinacea and lavender were the most effective.

This is the study that led to the four-plant combination: the botanicals in ASPIRA were chosen on the basis of laboratory screening, then tested as a finished tablet in people.

Why a tablet that sticks to the palate

Mints, gum and mouthwash share a practical limitation: they clear the mouth quickly. A mint masks odor for as long as the flavor lasts. Mouthwash is rinsed out within a minute. The mucoadhesive design tested in these studies takes a different approach - the tablet adheres to the palate and dissolves slowly, releasing the botanical extracts into saliva over an extended period. That is the mechanism the 2013 trial was built to test, which is why measurements were taken the following afternoon rather than minutes after use.

Frequently asked questions

Has ASPIRA been studied in clinical research?

Yes. The herbal formulation used in ASPIRA has been evaluated in published, peer-reviewed studies, including a randomized placebo-controlled trial in 40 people published in the Journal of Breath Research in 2013. That trial found significant reductions in odor judge scores, volatile sulfur compounds and salivary β-galactosidase activity compared with placebo. ASPIRA is a cosmetic product and these findings are about breath odor, not about treating any disease.

How many people were in the studies?

40 participants in the 2013 randomized controlled trial, and 56 volunteers across the experiments in the 2008 Journal of Dentistry study.

Where were the studies published?

Journal of Breath Research (2013), Journal of Dentistry (2008) and Quintessence International (2006). All three are peer-reviewed and indexed in PubMed.

What is in ASPIRA?

A patented herbal formulation of Echinacea, Lavender, Mastic Gum and Salvia (sage) extracts, delivered in a plant-based tablet that adheres to the palate and dissolves slowly.

How is ASPIRA different from mints, gum or mouthwash?

Mints and gum mask odor while the flavor lasts, and mouthwash is rinsed out of the mouth within about a minute. ASPIRA's tablet adheres to the palate and releases its botanical extracts gradually, which is the delivery method the published research was designed to evaluate.

Who is ASPIRA for, and how often can it be used?

ASPIRA is intended for adults and children aged 12 and over, and may be used up to three times daily. Each tablet is placed on the inside of the cheek or the central part of the upper palate, where it adheres and dissolves slowly.

Does ASPIRA treat halitosis caused by a medical condition?

No. ASPIRA is a cosmetic breath product intended for everyday freshness. Persistent bad breath can be caused by gum disease, dry mouth, sinus problems or other conditions, and should be assessed by a dentist or physician.

References
  1. Sterer N, Ovadia O, Weiss EI, Perez Davidi M. Day-long reduction of oral malodor by a palatal mucoadhesive tablet containing herbal formulation. J Breath Res. 2013;7(2):026004. doi:10.1088/1752-7155/7/2/026004 · PMID 23519054
  2. Sterer N, Nuas S, Mizrahi B, Goldenberg C, Weiss EI, Domb A, Perez Davidi M. Oral malodor reduction by a palatal mucoadhesive tablet containing herbal formulation. J Dent. 2008;36(7):535–539. doi:10.1016/j.jdent.2008.04.001 · PMID 18468761
  3. Sterer N, Rubinstein Y. Effect of various natural medicinals on salivary protein putrefaction and malodor production. Quintessence Int. 2006;37(8):653–658. PMID 16922026
  4. Clinical trial registration: ClinicalTrials.gov identifier NCT00250289, Hadassah Medical Organization.