Effektiviteten af Chlorhexidin og Morus Nigra mundskyllemidler efter parodontal behandling
Sammenligning af effekten af Chlorhexidin og Morus Nigra mundskyllemidler i behandlingen af paradentose
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.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
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Malatya
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Battalgazi, Malatya, Tyrkiet (Türkiye), 44300
- Inonu University Faculty of Dentistry
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: 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. |
|
Eksperimentel: 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. |
|
Eksperimentel: 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. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Gingival Index (GI)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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.
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Gingival Crevicular Fluid (GCF) Inflammatory Markers
Tidsramme: 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
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- INONU-2025/04
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
De-identified individual participant data that underlie the results reported in the published article will be shared
IPD-delingstidsramme
Data will be available beginning 6 months and ending 36 months following article publication.
IPD-delingsadgangskriterier
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
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
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