Ozone Gel Versus Chlorohexidine Gel as an Adjunct to Non-Surgical Treatment of Stage II Periodontitis Grade B Among Smokers Patients
Clinical and Biochemical Evaluation of Ozone Gel Versus Chlorohexidine Gel as an Adjunct to Non-Surgical Treatment of Stage II Periodontitis Grade B Among Smokers Patients
The aim of the present study is to evaluate and compare the clinical and biochemical outcomes of Ozoral® and High Cure® (chlorhexidine gel) as adjuncts to non-surgical periodontal therapy in smoker patients with Stage II Grade B periodontitis, using non-smoker patients with the same diagnosis as a comparative control group.
Studieoversigt
Status
Detaljeret beskrivelse
Periodontal diseases are disease processes involving the periodontium, a term used to describe the supportive apparatus surrounding a tooth, which includes the gingival tissue, alveolar bone, cementum, and periodontal ligament.
Chlorhexidine (CHX) has been widely used in dentistry as an antiplaque and antimicrobial agent due to its broad-spectrum activity against Gram-positive and Gram-negative bacteria, fungi, and some viruses. The antimicrobial action of chlorhexidine is mainly attributed to its ability to alter bacterial cell membrane permeability, resulting in leakage of intracellular components.
Ozone (O₃) is a highly reactive oxidizing agent that has gained increasing attention in medical and dental applications because of its potent antimicrobial, anti-inflammatory, and wound-healing properties. Ozone exerts its antimicrobial effect through oxidative damage to microbial cell walls and intracellular components, leading to rapid microbial inactivation.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Sara A Agha, B.D.S
- Telefonnummer: 00201025536848
- E-mail: Ahmedagha55aa@gmail.com
Studiesteder
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Cairo, Egypten, 12511
- Rekruttering
- October 6 University
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Underforsker:
- Osama S El-Shall, MD
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Kontakt:
- Sara A Agha, B.Sc
- Telefonnummer: 00201025536848
- E-mail: Ahmedagha55aa@gmail.com
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Underforsker:
- Amany A Al-Araby, MD
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Male and female patients aged 25-45 years
- Diagnosed with Stage II Grade B periodontitis
- Clinical attachment loss of 3-4 mm
- Radiographic bone loss confined to the coronal third of the root
- Either smokers or non-smokers
Exclusion Criteria:
- Systemic diseases affecting periodontal health
- Pregnancy or lactating female
- Periodontal therapy within the last 6 months
- Use of antibiotics or anti-inflammatory medication during the last
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: Group I (control - standard of care control)
Participants will receive conventional scaling and root planing only. |
Participants will receive conventional scaling and root planing only. |
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Eksperimentel: Group II (experimental)
Participants will receive conventional scaling and root planing in addition to chlorhexidine gel application according to the manufacturer's instructions for subgingival delivery. |
Participants will receive conventional scaling and root planing in addition to chlorhexidine gel application according to the manufacturer's instructions for subgingival delivery. |
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Eksperimentel: Group III (experimental)
Participants will receive conventional scaling and root planing in addition to ozone gel application according to the manufacturer's instructions for subgingival delivery. |
Participants will receive conventional scaling and root planing in addition to ozone gel application according to the manufacturer's instructions for subgingival delivery. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change in gingival crevicular fluid tumor necrosis factor-alpha level
Tidsramme: 6 months after treatment
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Change from baseline in gingival crevicular fluid tumor necrosis factor-alpha (TNF-α) level will be measured using enzyme-linked immunosorbent assay (ELISA) at baseline, 15 days, and 6 months after treatment.. |
6 months after treatment
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change in gingival crevicular fluid Interleukin-1 level
Tidsramme: 6 months after treatment
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Change from baseline in gingival crevicular fluid Interleukin-1(IL-1) evel will be measured using enzyme-linked immunosorbent assay (ELISA) at baseline, 15 days, and 6 months after treatment.. |
6 months after treatment
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Change in Plaque Index
Tidsramme: 6 months after treatment
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Change from baseline in Plaque Index, scored from 0 (no plaque) to 3 (abundant plaque accumulation). Lower scores indicate better oral hygiene. Changes will be compared among the three treatment groups. |
6 months after treatment
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Change in Gingival Index
Tidsramme: 6 months after treatment
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Change from baseline in Gingival Index, scored from 0 (normal gingiva) to 3 (severe inflammation with a tendency toward spontaneous bleeding). Lower scores indicate less gingival inflammation. Changes will be compared among the three treatment groups. |
6 months after treatment
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Change in Periodontal Probing Depth
Tidsramme: 6 months after treatment
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Change from baseline in periodontal probing depth will be measured in millimeters from the gingival margin to the base of the periodontal pocket using a periodontal probe. A reduction indicates improvement. Changes will be compared among the three treatment groups. |
6 months after treatment
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Change in Clinical Attachment Level
Tidsramme: 6 months after treatment
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Change from baseline in clinical attachment level will be measured in millimeters from the cementoenamel junction to the base of the periodontal pocket using a periodontal probe. A reduction in this distance indicates clinical attachment gain. Changes will be compared among the three treatment groups. |
6 months after treatment
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
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
- (4) 27/4/2026
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
IPD-delingstidsramme
After the end of study for one year.
IPD-delingsadgangskriterier
The data will be available upon a reasonable request from the corresponding author.
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
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