Clinical trial NCT06589193: Comparison of the Clinical and Microbiological Effects of CHX and HOCl Containing Mouthwashes
Official title: Comparison of the Clinical and Microbiological Effects of CHX and HOCl Containing Mouthwashes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Plaque
Keywords: Hypochlorous acid
chlorhexidine gluconate
antiplaque
anti-inflammatory
gingivitis
Lead sponsor: Baskent University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 4-day plaque regrowth study model
Primary purpose: PREVENTION

Brief summary: The primary objective of the study is to compare the antiplaque and anti-inflammatory effects of HOCl mouth rinse with those of CHX mouth rinse. The secondary objective is to evaluate and compare the antimicrobial activities of HOCl mouth rinse and CHX mouth rinse on dental biofilm.

Detailed description: The primary objective of the current clinical study is to compare the antiplaque and anti-inflammatory efficacy of HOCl mouth rinse with that of CHX mouth rinse. The secondary objective is to compare the antimicrobial activities of these two mouth rinses on dental biofilm. This single-center, triple-blind, randomized controlled crossover study was completed with 26 participants. In the study, the same participants used both HOCl (0.02%) and CHX (0.2%) mouth rinses over a 4-day re-plaque formation model. Following each mouth rinse usage, supragingival dental plaque biofilm samples were collected, and clinical parameters including the Modified Plaque Index, Bleeding on Probing Index, and Modified Stain Index were recorded. Additionally, participants were asked to evaluate the mouth rinses they used via a questionnaire. In conclusion, HOCl mouth rinse has demonstrated antiplaque efficacy comparable to that of CHX mouth rinse. When evaluating total bacterial counts, both mouth rinses exhibited similar antimicrobial effectiveness. Within the limitations of this study, HOCl may be considered a promising antimicrobial agent for dental plaque control.

Eligibility criteria: Inclusion Criteria:

* Being systematically healthy
* Having at least 22 natural teeth (236)
* Not smoking
* Participants must not drink alcohol and must work during their term

Exclusion Criteria:

* Having periodontitis and gingivitis
* Being breastfeeding or pregnant
* Using medication that may affect periodontal status
* Having used antibiotics in the last month
* Having used any mouthwash in the last month
* Using fixed, removable dentures or orthodontic appliances

Primary outcomes:
measure: plaque index
timeFrame: 1 month
Secondary outcomes:
measure: microbiology
timeFrame: 1 month
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Baskent University Faculty of Dentistry
Study officials:
affiliation: Başkent Üniversitesi
name: Mehtap Bilgin Cetin, Assoc. prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lafaurie GI, Zaror C, Diaz-Baez D, Castillo DM, De Avila J, Trujillo TG, Calderon-Mendoza J. Evaluation of substantivity of hypochlorous acid as an antiplaque agent: A randomized controlled trial. Int J Dent Hyg. 2018 Nov;16(4):527-534. doi: 10.1111/idh.12342. Epub 2018 Apr 2.