Efficacité des bains de bouche à la Chlorhexidine et au Morus Nigra après un traitement parodontal
Comparaison de l'efficacité des bains de bouche à la chlorhexidine et à Morus Nigra dans le traitement des maladies parodontales
This study aims to evaluate and compare the clinical, biochemical, and microbiological effects of chlorhexidine and Morus nigra (blackberry) mouthwashes used as an adjunct to non-surgical periodontal treatment (scaling and root planing - SRP) in patients with periodontal diseases. The participants will be divided into three groups: a control group receiving only SRP, a group receiving SRP combined with chlorhexidine mouthwash, and a group receiving SRP combined with Morus nigra mouthwash. Clinical periodontal parameters, gingival crevicular fluid levels of inflammatory markers (including TNF-a, IL-1b, and IL-10), and subgingival plaque microbiological profiles (such as red complex bacteria and Fusobacterium) will be evaluated at baseline, 1 month, and 3 months after the treatment.
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Malatya
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Battalgazi, Malatya, Turquie (Türkiye), 44300
- Inonu 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:
- Patients diagnosed with periodontitis.
- Systemically healthy individuals.
- Patients aged between 18 and 65 years.
- Presence of at least 20 natural teeth.
- Volunteering to participate in the study and signing the informed consent form.
Exclusion Criteria:
- Presence of any systemic disease that may affect periodontal health or systemic inflammatory response (e.g., Diabetes Mellitus, immunological disorders).
- Current smokers or use of any tobacco products.
- Pregnancy or lactation.
- Use of systemic antibiotics, anti-inflammatory drugs, or immunosuppressive medications within the last 6 months.
- Having received any non-surgical or surgical periodontal treatment within the last 6 months.
- Known allergy or sensitivity to chlorhexidine or Morus nigra (blackberry) extracts.
- Patients using orthodontic appliances.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: Control Group
Non-surgical periodontal treatment consisting of full-mouth scaling and root planing (SRP) using ultrasonic and hand instruments. |
All patients in the study underwent non-surgical periodontal therapy consisting of full-mouth scaling and root planing (SRP) using both ultrasonic devices and hand instruments. |
|
Expérimental: Chlorhexidine Group
As an adjunct to scaling and root planing, patients will rinse with 15 ml of 0.12% chlorhexidine gluconate mouthwash twice a day (morning and evening) for 1 minute. The duration of the intervention is 14 days. |
All patients in the study underwent non-surgical periodontal therapy consisting of full-mouth scaling and root planing (SRP) using both ultrasonic devices and hand instruments. As an adjunct to SRP, patients were instructed to rinse with 15 ml of 0.12% chlorhexidine gluconate mouthwash twice daily (morning and evening) for 1 minute. The treatment duration was 14 days. |
|
Expérimental: Morus Nigra Group
As an adjunct to scaling and root planing, patients will rinse with 15 ml of a standardized mouthwash containing 5% Morus nigra extract twice a day (morning and evening) for 1 minute. The duration of the intervention is 14 days. |
All patients in the study underwent non-surgical periodontal therapy consisting of full-mouth scaling and root planing (SRP) using both ultrasonic devices and hand instruments. As an adjunct to SRP, patients were instructed to rinse with 15 ml of a standardized mouthwash containing 5% Morus nigra extract twice daily (morning and evening) for 1 minute. The treatment duration was 14 days. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Gingival Index (GI)
Délai: Baseline (Day 0), 1 month, and 3 months after periodontal treatment.
|
Evaluation of gingival inflammation using a scale of 0 to 3. |
Baseline (Day 0), 1 month, and 3 months after periodontal treatment.
|
|
Plaque Index (PI)
Délai: Baseline (Day 0), 1 month, and 3 months after periodontal treatment.
|
Evaluation of plaque accumulation using a scale of 0 to 3. |
Baseline (Day 0), 1 month, and 3 months after periodontal treatment.
|
|
Probing Depth (PD)
Délai: Baseline (Day 0), 1 month, and 3 months after periodontal treatment.
|
Measurement of the distance from the gingival margin to the bottom of the periodontal pocket. |
Baseline (Day 0), 1 month, and 3 months after periodontal treatment.
|
|
Clinical Attachment Level (CAL)
Délai: Baseline (Day 0), 1 month, and 3 months after periodontal treatment.
|
Measurement of the distance from the cementoenamel junction to the bottom of the periodontal pocket. |
Baseline (Day 0), 1 month, and 3 months after periodontal treatment.
|
|
Bleeding on Probing (BOP)
Délai: Baseline (Day 0), 1 month, and 3 months after periodontal treatment.
|
Evaluation of the presence or absence of bleeding within 30 seconds after probing. The result is recorded as a percentage of sites that bleed. |
Baseline (Day 0), 1 month, and 3 months after periodontal treatment.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Gingival Crevicular Fluid (GCF) Inflammatory Markers
Délai: At baseline, 1 month, and 3 months after treatment
|
Analysis of TNF-a, IL-1b, and IL-10 levels in the gingival crevicular fluid using ELISA (or specific biochemical assay) to evaluate the local inflammatory response |
At baseline, 1 month, and 3 months after treatment
|
|
Change in Subgingival Plaque Microbiological Profile
Délai: At baseline, 1 month, and 3 months after treatment
|
Evaluation of subgingival plaque samples to determine the levels of red complex bacteria and Fusobacterium nucleatum using PCR (Polymerase Chain Reaction) analysis |
At baseline, 1 month, and 3 months after treatment
|
Collaborateurs et enquêteurs
Parrainer
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
Termes MeSH pertinents supplémentaires
- Maladies de la bouche
- Maladies stomatognathiques
- Parodontite
- Maladies parodontales
- Système digestif et phénomènes physiologiques oraux
- Dentisterie
- Phénomènes physiologiques dentaires
- Échelle dentaire
- Prophylaxie dentaire
- Parodontie
- Curetage de sous-gingival
- Dentisterie préventive
- Planage racinaire
- Exfoliation dentaire
Autres numéros d'identification d'étude
- INONU-2025/04
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
De-identified individual participant data that underlie the results reported in the published article will be shared
Délai de partage IPD
Data will be available beginning 6 months and ending 36 months following article publication.
Critères d'accès au partage IPD
Data will be shared with researchers who provide a methodologically sound proposal. Requests for data sharing should be directed to the principal investigator via email
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
Informations sur les médicaments et les dispositifs, documents d'étude
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