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Evidence

The evidence behind Aquoral.

Clinical trials and laboratory testing of OGT technology, the lipid-based formulation in Aquoral.

Proven clinical performance

The safety and efficacy of OGT technology have been proven in clinical trials. Study results demonstrate a significant improvement in the symptoms of xerostomia including chewing, swallowing, taste, and speech.7,8

Patients enrolled in clinical trials tested OGT spray, and researchers compared their responses to patients who used an aqueous-based saliva substitute. The clinical trials focused on geriatric patients, patients with medication-induced xerostomia, and patients who had received head and neck radiation therapy.7,8,9

In all three clinical trials, OGT spray was shown to provide significant benefits to most patients.

  • A majority of patients in the medication-induced xerostomia clinical trial said OGT spray enhanced both their ability to chew (73 percent) and swallow (65 percent).
  • Eighty-four percent of the patients said it also improved their quality of life.
  • OGT spray also lasted longer, with 78 percent saying they used it three to four times per day and only 19 percent saying they used it four or more times per day.
  • The taste of the spray was considered good for both products but far better for OGT spray (mean score 7.2 for the OGT spray vs. 5.5 for the aqueous-based spray).
  • Eighty-seven percent of the patients reported that they felt better from using OGT spray and that it was easy to use.
  • There were no unpleasant or adverse effects for 94 percent of patients who used OGT spray, and 78 percent said they wished to continue using the product.

The researchers concluded that the lubricating and protective qualities of OGT, in comparison with an aqueous solution, improved the feelings of dry mouth and improved many important factors related to patients’ quality of life, which can be severely affected by xerostomia.8

Published in the Cochrane Database of Systematic Reviews, a 2011 review comparing xerostomia interventions concluded that lipid-based OGT technology shows greater effectiveness when compared to water-based electrolyte sprays.10

Laboratory testing designed to mimic the effects of xerostomia products on soft tissue confirms the efficacy of OGT technology. Using novel in vitro test methods to measure lubricity and moisture retention, researchers at 3M and the University of Minnesota School of Dentistry conducted comparative experiments of OGT spray and some common, commercially available xerostomia products.11,12

Lubricity

The University of Minnesota has developed a reciprocating mechanical system, which models the relative movement of the mandibular and maxillary structures in the mouth and was used to study the friction between simulated hard and soft oral tissues in the presence of various xerostomia relief products.11 Using either dry tissue or tissue lubricated only with water as controls, researchers were able to measure the coefficient of friction, otherwise known as lubricity, for each product and found that OGT spray was the most efficient at lubricating the hard tissues tested. In the experiment, the mean coefficients of friction were significantly different between all groups tested. The mean coefficient of friction of OGT spray was four times lower than the hard tissue controls that were left dry.11

Moisture retention

Researchers at 3M have found a unique way to test for moisture retention. They found that OGT spray performed statistically better at preventing water loss when tested against many commercially available xerostomia relief products. Using a technique named thermogravimetric analysis, which measures moisture loss over time at specific temperatures, researchers used samples of sirloin steak to represent human soft tissue and coated them with xerostomia relief products. As the temperature of the test instrument is increased to body temperature, the sirloin steak begins to lose water. After four hours at body temperature, the percentage of weight lost by each sample can be measured and converted into the percentage of total water lost after four hours. The sirloin steak samples coated with OGT spray showed significantly less water loss compared to many competitive Xerostomia products. This low level of water loss suggests a moisture-protective effect that the OGT spray exhibits on intraoral tissues. OGT spray was able to prevent water loss and provide more lubricity than any of the other products tested.12

OGT (oxidized glycerol triesters) is the lipid-based technology in Aquoral. How Aquoral works.

Bibliography

  1. Mravak-Stipetic, M. (2012). Xerostomia-diagnostics and treatment. Rad 514 Medical Sciences, 38, 69-91. Retrieved April 11, 2018.
  2. Ligtenberg, A. J. M., & Veerman, E. C. I. (Eds.). (2014). Saliva: Secretion and Functions. Monographs in Oral Science, 24, 71-87.
  3. Lamoreux, D. (2014, March 11). Finding comfort with a dry mouth. Retrieved April 11, 2018, from http://www.rdhmag.com/articles/print/volume-34/issue-3/features/finding-comfort-with-a-dry-mouth.html
  4. U.S. Department of Health and Human Services. (2017). National Institutes of Health [Brochure]. Retrieved April 11, 2018, from https://www.nidcr.nih.gov/sites/default/files/2017-11/dry-mouth.pdf?_ga=2.2432368.1568241077.1520885563-1503646232.1470250426
  5. Sankar, V., & Rhodus, N. (2015, October 15). Xerostomia. Retrieved April 11, 2018, from http://www.aaom.com/index.php?option=com_content&view=article&id=107:xerostomia&catid=22:patient-conditioninformation&Itemid=120
  6. Tiwari, M. (2011). Science behind human saliva. Journal of Natural Science, Biology and Medicine, 2(1), 53. doi:10.4103/0976-9668.82322
  7. Mouly, S., & Salom, M. (2007). Management of Xerostomia in Older Patients. Drugs & Aging, 24(11), 957-965. doi:10.2165/00002512-200724110
  8. Mouly, S., & Orler, J. (2007). Efficacy of a New Oral Lubricant Solution in the Management of Psychotropic Drug-Induced Xerostomia. Journal of Clinical Psychopharmacology, 27(5), 437-443. doi:10.1097/jcp.0b013e31814db434
  9. Preshaw, P. (2004). A positive control, one centre, parallel group studyto evaluate the efficacy of OGT lubricant versus reference product in the management of xerostomia. School of Dental Sciences, University of Newcastle, UK.
  10. Furness, S., & Worthington, H. V. (2011). Interventions for the management of dry mouth: topical therapies. Cochrane Database of Systematic Reviews. doi:10.1002/14651858.cd008934.pub2
  11. Heo, Y. C., Olivares Treviño, J. A. (2), Lan, T. H., Holmes, B. N., Chew, H. P., & F ok, A. S. L. (2018 ). Method for measuring friction between simulated soft and hard oral tissues in response to xerostomia treatment. All University of Minnesota School of Dentistry, except (2) Universidad Autónoma de Nuevo León, Mexico.
  12. Yang, J. (2018). Novel in-vitro Moisture Retention Test for Xerostomia Products [Abstract]. Journal of Dental Research, 97, Special Issue(A).

Study results are summarised from the publications listed. Content adapted for Canada; pending review.