Comparison of the Clinical and Microbiological Effects of CHX and HOCl Containing Mouthwashes
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.
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Ankara, Turecko (Türkiye), 06000
- Baskent University Faculty of Dentistry
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Crossover Assignment
- Maskování: Čtyřnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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. |
Rinse with 10 mL for one minute, twice daily for four days. Rinse with 10 mL for one minute, twice daily for four days. |
|
Experimentální: 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. |
Rinse with 10 mL for one minute, twice daily for four days. Rinse with 10 mL for one minute, twice daily for four days. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Modified Plaque Index
Časové okno: At the end of each four-day treatment period.
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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.
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Total culturable bacterial count in supragingival plaque
Časové okno: At the end of each four-day treatment period.
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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.
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Bleeding on Probing (BOP)
Časové okno: At the end of each four-day treatment period.
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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.
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Modified Stain Index (MSI)
Časové okno: At the end of each four-day treatment period.
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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.
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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Participant-reported experience with mouthwashes
Časové okno: At the end of each four-day treatment period.
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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.
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Final mouthwash preference
Časové okno: After completion of both four-day treatment periods and the intervening 14-day washout period.
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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.
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Mehtap Bilgin Cetin, Associate Professor, Baskent University
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Stomatognátní onemocnění
- Nemoci zubů
- Zubní vklady
- Zubní plak
- Chemické účinky a použití
- Anorganické chemikálie
- Sloučeniny chloru
- Biomedicínské a zubní materiály
- Vyrobené materiály
- Technologie, průmysl a zemědělství
- Speciální použití chemikálií
- Oxidy
- Kyslíkové sloučeniny
- Kyseliny, nekarboxylové
- Kyseliny
- Reaktivní druhy kyslíku
- Volné radikály
- Kosmetika
- Chlorhexidin glukonát
- Ústní vody
- Kyselina chlorná
Další identifikační čísla studie
- MR1234
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
A decision regarding sharing individual participant data has not yet been made.
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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