- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT06589193
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Ankara, Turquie (Türkiye), 06000
- Baskent University Faculty of Dentistry
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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. |
|
Expérimental: 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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Modified Plaque Index
Délai: 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.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Total culturable bacterial count in supragingival plaque
Délai: 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)
Délai: 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.
|
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Modified Stain Index (MSI)
Délai: 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.
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Participant-reported experience with mouthwashes
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Mehtap Bilgin Cetin, Associate Professor, Baskent University
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies stomatognathiques
- Maladies dentaires
- Dépôts dentaires
- La plaque dentaire
- Actions et utilisations chimiques
- Produits chimiques inorganiques
- Composés de chlore
- Matériaux biomédicaux et dentaires
- Matériaux fabriqués
- Technologie, industrie et agriculture
- Utilisations spéciales de produits chimiques
- Oxydes
- Composés d'oxygène
- Acides, non carboxylique
- Acides
- Espèces réactives de l'oxygène
- Radicaux libres
- Produits de beauté
- gluconate de chlorhexidine
- Caves de bouche
- Acide Hypochloreux
Autres numéros d'identification d'étude
- MR1234
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
A decision regarding sharing individual participant data has not yet been made.
Informations sur les médicaments et les dispositifs, documents d'étude
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