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

2. november 2026 oppdatert av: Mehtap Bilgin Çetin, Baskent University

This study compared two mouthwashes, containing hypochlorous acid (HOCl) or chlorhexidine (CHX), for their effects on dental plaque accumulation, gum bleeding, tooth staining, and bacteria in dental plaque. Participants used each mouthwash during a separate four-day period, with a washout period between treatments. Participants also evaluated their experience with each mouthwash using a questionnaire.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

This single-center, randomized controlled crossover study compared mouthwashes containing 0.02% hypochlorous acid (HOCl) and 0.2% chlorhexidine (CHX) using a four-day plaque regrowth model. Thirty participants were enrolled, and 26 completed both treatment periods.

Each mouthwash was used twice daily, with 10 mL rinsed for one minute, during a four-day period. The treatment periods were separated by a 14-day washout period. Professional prophylaxis was performed at the beginning of each treatment period. Participants refrained from toothbrushing and interdental cleaning during the treatment periods.

Clinical assessments included the Modified Plaque Index, bleeding on probing, and the Modified Stain Index. Supragingival plaque samples were collected at the end of each treatment period for microbiological analysis, including bacterial colony counts and identification by MALDI-TOF mass spectrometry. Participants completed a questionnaire evaluating their experience with each mouthwash and indicated their final preference.

Studietype

Intervensjonell

Registrering (Faktiske)

30

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Tyrkia (Türkiye)
      • Ankara, Tyrkia (Türkiye), 06000
        • Baskent University Faculty of Dentistry

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 65 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Systemically healthy.
  • Aged 18-65 years.
  • Having at least 22 natural teeth.
  • Nonsmoker.
  • Willing to abstain from alcohol throughout the study.

Exclusion Criteria:

  • Presence of periodontitis or gingivitis.
  • Pregnancy or breastfeeding.
  • Use of medications that may affect periodontal status.
  • Antibiotic or anti-inflammatory medication use within the previous six months.
  • Use of antimicrobial mouth rinses, gels, or chewing gums within the previous three months.
  • Known allergy to any component of the study mouth rinses.
  • Presence of tongue conditions, such as geographic tongue or hairy tongue.
  • Periodontal probing depths of 4 mm or greater.
  • Gingival recession of 2 mm or greater.
  • Use of fixed or removable dental prostheses, including single crowns, or orthodontic appliances.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: HOCl followed by CHX

Participants used 0.02% hypochlorous acid mouthwash for four days, followed by a 14-day washout period, and then 0.2% chlorhexidine gluconate mouthwash for four days. Each mouthwash was used twice daily, with 10 mL rinsed for one minute.
Annen: Hypochlorous acid 0.02% mouthwash

Rinse with 10 mL for one minute, twice daily for four days.

Annen: Chlorhexidine gluconate 0.2% mouthwash

Rinse with 10 mL for one minute, twice daily for four days.
Eksperimentell: CHX followed by HOCl

Participants used 0.2% chlorhexidine gluconate mouthwash for four days, followed by a 14-day washout period, and then 0.02% hypochlorous acid mouthwash for four days. Each mouthwash was used twice daily, with 10 mL rinsed for one minute.
Annen: Hypochlorous acid 0.02% mouthwash

Rinse with 10 mL for one minute, twice daily for four days.

Annen: Chlorhexidine gluconate 0.2% mouthwash

Rinse with 10 mL for one minute, twice daily for four days.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Modified Plaque Index
Tidsramme: At the end of each four-day treatment period.

Dental plaque was assessed using the modified Silness and Löe Plaque Index at six sites per tooth. Each site was scored from 0 (no plaque) to 3 (abundant plaque). Mean scores were calculated for the full mouth and 12 anatomical regions and compared between the HOCl and CHX treatment periods. Mean scores range from 0 to 3; higher scores indicate greater plaque accumulation.
At the end of each four-day treatment period.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Total culturable bacterial count in supragingival plaque
Tidsramme: At the end of each four-day treatment period.

Total culturable bacterial counts were measured in supragingival plaque samples collected from molar teeth and expressed as colony-forming units per milliliter (CFU/mL). Counts were compared between the HOCl and CHX treatment periods.
At the end of each four-day treatment period.
Bleeding on Probing (BOP)
Tidsramme: At the end of each four-day treatment period.

Bleeding was assessed at six sites per tooth using a periodontal probe. Sites showing bleeding within 30 seconds after probing were recorded as positive. BOP was calculated as the number of bleeding sites divided by the total number of examined sites, multiplied by 100. Full-mouth and regional percentages were calculated. Scores range from 0% to 100%; higher values indicate more gingival bleeding.
At the end of each four-day treatment period.
Modified Stain Index (MSI)
Tidsramme: At the end of each four-day treatment period.

Extrinsic tooth staining was assessed in four regions on each buccal and lingual/palatal tooth surface. Intensity was scored from 0 to 3. Area was scored from 1 to 3 only when intensity was 2 or 3, using the region-specific criteria of Macpherson et al. (2000). For intensity scores of 1, the intensity × area value was defined as 1. The participant-level MSI was calculated by averaging these values across examined regions, with a range of 0-9. Higher scores indicate greater staining.
At the end of each four-day treatment period.

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Participant-reported experience with mouthwashes
Tidsramme: At the end of each four-day treatment period.

At the end of each treatment period, participants completed a five-item questionnaire assessing mouthwash taste, effects on taste perception, perceived tooth cleanliness, perceived tooth discoloration, and nausea associated with mouthwash use. Each item was rated as 1 (poor), 2 (moderate), or 3 (good). Higher scores indicate a more favorable participant rating. Each item was evaluated separately.
At the end of each four-day treatment period.
Final mouthwash preference
Tidsramme: After completion of both four-day treatment periods and the intervening 14-day washout period.

After completing both treatment periods, participants indicated which of the two mouthwashes they preferred. The number of participants preferring each mouthwash was recorded.
After completion of both four-day treatment periods and the intervening 14-day washout period.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Baskent University

Etterforskere

  • Hovedetterforsker: Mehtap Bilgin Cetin, Associate Professor, Baskent University

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

28. mars 2022

Primær fullføring (Faktiske)

19. april 2022

Studiet fullført (Faktiske)

19. april 2022

Datoer for studieregistrering

Først innsendt

29. august 2024

Først innsendt som oppfylte QC-kriteriene

5. september 2024

Først lagt ut (Faktiske)

19. september 2024

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

4. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. november 2026

Sist bekreftet

1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • MR1234

Plan for individuelle deltakerdata (IPD)

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UBESLUTTE

IPD-planbeskrivelse

A decision regarding sharing individual participant data has not yet been made.

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