Tier 2 — strong

Evaluation of the clinical efficacy of a betaine-containing mouthwash and an intraoral device for the treatment of dry mouth

Pia López-Jornet, Fabio Camacho-Alonso, Consuelo Rodriguez-Aguado
Journal of oral pathology & medicine : official publication of the International Association of Oral Pathologists and the American Academy of Oral Pathology 2012 41(3):201-206

Bibliography

PubMed
PMID 21950587
DOI
10.1111/j.1600-0714.2011.01088.x
Funding
Funding was not specified in the indexed record or accessible funding metadata.
Competing interests
A competing-interest declaration was not available in the indexed record or accessible disclosure metadata.

Study snapshot

DesignRandomized open-label RCT
ModelHuman participants
Sample105 dry-mouth patients; 90 completed
InterventionBetaine-containing mouthwash, night guard or both
Duration4 weeks
EndpointsXerostomia; Salivary flow; Oral quality of life

What the study showed, in plain terms

Published in 2012, this source examined betaine hcl and topical formulations. Design: Randomized open-label RCT. Sample/model: 105 dry-mouth patients; 90 completed. The exposure or intervention was Betaine-containing mouthwash, night guard or both. Follow-up or treatment period: 4 weeks.

All three approaches improved symptoms and salivary measurements; satisfaction did not significantly differ among groups.

No blinded placebo comparison and several active approaches; a specific betaine effect remains uncertain.

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Key findings

  • All three approaches improved symptoms and salivary measurements; satisfaction did not significantly differ among groups.
  • The recorded outcome domains were Xerostomia; Salivary flow; Oral quality of life.
  • The result applies to the tested exposure: Betaine-containing mouthwash, night guard or both; 4 weeks.

What this study can and cannot tell us

  • No blinded placebo comparison and several active approaches; a specific betaine effect remains uncertain.
  • Without a sufficiently blinded concurrent control, time effects, expectations, co-interventions and regression toward the mean can explain part of an apparent improvement.
  • Source basis: Indexed abstract and bibliographic data. Missing method details, funding information or participant denominators are not inferred.

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Dr. Khaled Mahmoud, MBBChCritical Care Medicine, Longevity Science & Editorial Direction Dr. Amr Yasser, PhDCardiometabolic, Musculoskeletal, Gut & Bioavailability Dr. Abdulla Mostafa, PhDCellular Senescence, Neurological, Mitochondrial & Brain-Ageing Biology