Hyperpure chlorine dioxide versus chlorhexidine in intra-oral halitosis (ODOR trial) – protocol of a double-blinded, double-arm, parallel non-inferiority pilot randomized controlled trial

Introduction Intra-oral halitosis (IOH) is the most common type of bad breath; its consequences impair quality of life. However, evidence-based treatment protocols and guidelines are lacking. Our aim is to investigate the effectiveness of chlorine dioxide as an applicable complementary treatment mod...

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Bibliographic Details
Published in:BDJ open 2024-05, Vol.10 (1), p.35-35, Article 35
Main Authors: Szalai, Eszter Ágnes, Teutsch, Brigitta, Babay, Viktória, Galvács, Adél, Hegyi, Péter, Hársfalvi, Péter, Pál, Róbert, Varga, Gábor, Lohinai, Zsolt M., Kerémi, Beáta
Format: Article
Language:English
Subjects:
692/699/3020
692/700/3032/3129/3135
Chlorhexidine
Chlorine
Chlorine compounds
Chlorine dioxide
Clinical trials
Dentistry
Dentists
Endodontics
Halitosis
Intervention
Medicine
Odor
Odors
Off odor
Quality of life
Sample size
Sulfur
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Summary:Introduction Intra-oral halitosis (IOH) is the most common type of bad breath; its consequences impair quality of life. However, evidence-based treatment protocols and guidelines are lacking. Our aim is to investigate the effectiveness of chlorine dioxide as an applicable complementary treatment modality in IOH after tongue cleaning. Methods and analysis The ODOR trial will be a single-center, double-blinded, parallel-group, double-armed pilot randomized controlled trial with a non-inferiority design. The efficacy of hyperpure chlorine dioxide will be compared to chlorhexidine mouthwash. We plan to investigate the short-term effects of the intervention over a 3-h period. The primary endpoint will be changes in organoleptic test scores. At the end of the pilot investigation of the first 30 patients each, sample size calculation will be performed. If feasible, the investigators will continue the study by enrolling more patients. Trial registration The trial has been registered at ClinicalTrials.gov (NCT06219226).
ISSN:2056-807X
2056-807X
DOI:10.1038/s41405-024-00221-8