NCT06589193

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 26, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

August 29, 2024

Completed
21 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

1.4 years

First QC Date

August 29, 2024

Last Update Submit

September 5, 2024

Conditions

Keywords

Hypochlorous acidchlorhexidine gluconateantiplaqueanti-inflammatorygingivitis

Outcome Measures

Primary Outcomes (1)

  • plaque index

    Plaque index results were evaluated regionally and full mouth for CHX and HOCl groups.

    1 month

Secondary Outcomes (1)

  • microbiology

    1 month

Study Arms (2)

HOCl

EXPERIMENTAL
Other: HOCl

CHX

ACTIVE COMPARATOR
Other: CHX

Interventions

HOClOTHER

10ml,twice a day

HOCl
CHXOTHER

10ml,twice a day

CHX

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baskent University Faculty of Dentistry

Ankara, 06000, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 29608039BACKGROUND

MeSH Terms

Conditions

Dental PlaqueGingivitis

Condition Hierarchy (Ancestors)

Dental DepositsTooth DiseasesStomatognathic DiseasesInfectionsGingival DiseasesPeriodontal DiseasesMouth Diseases

Study Officials

  • Mehtap Bilgin Cetin, Assoc. prof.

    Başkent Üniversitesi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: 4-day plaque regrowth study model
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

August 29, 2024

First Posted

September 19, 2024

Study Start

March 15, 2021

Primary Completion

August 26, 2022

Study Completion

September 30, 2022

Last Updated

September 19, 2024

Record last verified: 2024-09

Locations