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

Overview

Journal BDJ Open

Specialty Dentistry

Date 2024 May 20

PMID 38769314

Authors

Eszter Agnes Szalai

Brigitta Teutsch

Viktoria Babay

Adel Galvacs

Peter Hegyi

Peter Harsfalvi

Robert Pal

Gabor Varga

Zsolt M Lohinai

Beata Keremi

Affiliations

Soon will be listed here.

Abstract

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).

References

Jones C . Chlorhexidine: is it still the gold standard?. Periodontol 2000. 1998; 15:55-62. DOI: 10.1111/j.1600-0757.1997.tb00105.x. View

Pham T, Nguyen N . Efficacy of chlorine dioxide mouthwash in reducing oral malodor: A 2-week randomized, double-blind, crossover study. Clin Exp Dent Res. 2018; 4(5):206-215. PMC: 6203824. DOI: 10.1002/cre2.131. View

Herczegh A, Csak B, Dinya E, Moldovan A, Ghidan A, Palcso B . Short- and long term antibacterial effects of a single rinse with different mouthwashes: A randomized clinical trial. Heliyon. 2023; 9(4):e15350. PMC: 10121446. DOI: 10.1016/j.heliyon.2023.e15350. View

Santos D, Peralta-Mamani M, Brandao F, Andrade F, Cruvinel T, Santos P . Could polyhexanide and chlorine dioxide be used as an alternative to chlorhexidine? A systematic review. Sao Paulo Med J. 2021; 140(1):42-55. PMC: 9623834. DOI: 10.1590/1516-3180.2020.0776.R1.18052021. View

De Geest S, Laleman I, Teughels W, Dekeyser C, Quirynen M . Periodontal diseases as a source of halitosis: a review of the evidence and treatment approaches for dentists and dental hygienists. Periodontol 2000. 2016; 71(1):213-27. DOI: 10.1111/prd.12111. View

Dadamio J, Van Tournout M, Teughels W, Dekeyser C, Coucke W, Quirynen M . Efficacy of different mouthrinse formulations in reducing oral malodour: a randomized clinical trial. J Clin Periodontol. 2013; 40(5):505-13. DOI: 10.1111/jcpe.12090. View

Quirynen M, Avontroodt P, Peeters W, Pauwels M, Coucke W, van Steenberghe D . Effect of different chlorhexidine formulations in mouthrinses on de novo plaque formation. J Clin Periodontol. 2001; 28(12):1127-36. DOI: 10.1034/j.1600-051x.2001.281207.x. View

Schertel Cassiano L, Abdullahi F, Leite F, Lopez R, Peres M, Nascimento G . The association between halitosis and oral-health-related quality of life: A systematic review and meta-analysis. J Clin Periodontol. 2021; 48(11):1458-1469. DOI: 10.1111/jcpe.13530. View

Erovic Ademovski S, Lingstrom P, Renvert S . The effect of different mouth rinse products on intra-oral halitosis. Int J Dent Hyg. 2015; 14(2):117-23. DOI: 10.1111/idh.12148. View

10.

Yaegaki K, Brunette D, Tangerman A, Choe Y, Winkel E, Ito S . Standardization of clinical protocols in oral malodor research. J Breath Res. 2012; 6(1):017101. DOI: 10.1088/1752-7155/6/1/017101. View

11.

Silva M, Leite F, Ferreira L, Pola N, Scannapieco F, Demarco F . Estimated prevalence of halitosis: a systematic review and meta-regression analysis. Clin Oral Investig. 2017; 22(1):47-55. DOI: 10.1007/s00784-017-2164-5. View

12.

Wylleman A, Vuylsteke F, Dekeyser C, Teughels W, Quirynen M, Laleman I . Alternative therapies in controlling oral malodour: a systematic review. J Breath Res. 2020; 15(2). DOI: 10.1088/1752-7163/abcd2b. View

13.

Lynch E, Sheerin A, Claxson A, Atherton M, Rhodes C, Silwood C . Multicomponent spectroscopic investigations of salivary antioxidant consumption by an oral rinse preparation containing the stable free radical species chlorine dioxide (ClO2.). Free Radic Res. 1997; 26(3):209-34. DOI: 10.3109/10715769709097801. View

14.

Olshan A, Kohut B, Vincent J, Borden L, Delgado N, Qaqish J . Clinical effectiveness of essential oil-containing dentifrices in controlling oral malodor. Am J Dent. 2002; 13(Spec No):18C-22C. View

15.

van den Broek A, Feenstra L, de Baat C . A review of the current literature on management of halitosis. Oral Dis. 2008; 14(1):30-9. DOI: 10.1111/j.1601-0825.2006.01350.x. View

16.

Lee S, Suprono M, Stephens J, Withers S, Oyoyo U, Li Y . A randomized, blinded, clinical investigation of breath odor reduction efficacy of a stabilized chlorine-dioxide containing flavored mouthwash. Am J Dent. 2021; 34(4):195-200. View

17.

Wang J, He L . Comparison of the Psychological Condition of Chinese Patients with or without Halitosis Complaints. Chin J Dent Res. 2018; 21(1):69-76. DOI: 10.3290/j.cjdr.a39920. View

18.

Lee S, Suprono M, Stephens J, Withers S, Li Y . Efficacy of stabilized chlorine dioxide-based unflavored mouthwash in reducing oral malodor: An 8-week randomized controlled study. Am J Dent. 2019; 31(6):309-312. View

19.

Noszticzius Z, Wittmann M, Kaly-Kullai K, Beregvari Z, Kiss I, Rosivall L . Chlorine dioxide is a size-selective antimicrobial agent. PLoS One. 2013; 8(11):e79157. PMC: 3818415. DOI: 10.1371/journal.pone.0079157. View

20.

Herczegh A, Gyurkovics M, Agababyan H, Ghidan A, Lohinai Z . Comparing the efficacy of hyper-pure chlorine-dioxide with other oral antiseptics on oral pathogen microorganisms and biofilm in vitro. Acta Microbiol Immunol Hung. 2013; 60(3):359-73. DOI: 10.1556/AMicr.60.2013.3.10. View