Comparison of the Clinical and Microbiological Effects of CHX and HOCl Containing Mouthwashes

NCT ID: NCT06589193

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-15

Study Completion Date

2022-09-30

Brief Summary

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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

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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.

Conditions

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Dental Plaque

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

4-day plaque regrowth study model
Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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HOCl

Group Type EXPERIMENTAL

HOCl

Intervention Type OTHER

10ml,twice a day

CHX

Group Type ACTIVE_COMPARATOR

CHX

Intervention Type OTHER

10ml,twice a day

Interventions

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HOCl

10ml,twice a day

Intervention Type OTHER

CHX

10ml,twice a day

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Baskent University

OTHER

Sponsor Role lead

Responsible Party

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Mehtap Bilgin Çetin

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mehtap Bilgin Cetin, Assoc. prof.

Role: PRINCIPAL_INVESTIGATOR

Başkent Üniversitesi

Locations

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Baskent University Faculty of Dentistry

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 29608039 (View on PubMed)

Other Identifiers

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MR1234

Identifier Type: -

Identifier Source: org_study_id

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