- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07604636
Adjunctive Ozone Therapy for Residual Periodontal Pockets (OZPOCKET)
Clinical and Microbiological Effects of Adjunctive Ozone Application During Repeated Scaling and Root Planing for Residual Periodontal Pockets in Periodontal Maintenance Patients: A 6-Month Randomized Controlled Clinical Trial
Patients with residual periodontal pockets following non-surgical periodontal therapy remain at risk for disease progression and may require further periodontal surgery. Repeated scaling and root planing (SRP) is commonly used for residual pockets; however, complete elimination of periodontal pathogens is often difficult to achieve. Ozone therapy has antimicrobial, anti-inflammatory, and wound-healing properties that may improve periodontal treatment outcomes.
The aim of this randomized controlled clinical trial is to clinically and microbiologically evaluate the adjunctive effects of gaseous ozone application during repeated SRP for residual periodontal pockets in patients undergoing periodontal maintenance therapy. Twenty-six patients diagnosed with stage III or IV periodontitis presenting with residual periodontal pockets ≥5 mm with bleeding on probing will be included. Residual pockets will be randomly assigned to either repeated SRP alone (control group) or repeated SRP combined with ozone application (test group).
Clinical periodontal parameters and microbiological findings will be evaluated at baseline, 3 months, and 6 months after treatment.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Periodontitis is a chronic multifactorial inflammatory disease associated with dysbiotic subgingival biofilm and progressive destruction of tooth-supporting tissues. Although scaling and root planing (SRP) represents the gold standard of non-surgical periodontal therapy, residual periodontal pockets may persist after treatment, especially in patients with stage III and IV periodontitis. Residual pockets ≥5 mm with bleeding on probing are associated with increased risk of disease recurrence and often require additional interventions.
Adjunctive therapeutic approaches have been proposed to improve outcomes of non-surgical periodontal treatment. Ozone therapy has attracted increasing interest in periodontology because of its antimicrobial, anti-inflammatory, antihypoxic, immunomodulatory, and wound-healing effects. However, evidence regarding the adjunctive use of ozone in residual periodontal pockets remains limited.
This study was designed as a split-mouth, randomized-controlled, double-blind clinical trial with a 6-month follow-up period. Twenty-six systemically healthy individuals diagnosed with stage III or IV periodontitis and undergoing periodontal maintenance therapy will be included. Patients presenting with residual periodontal pockets ≥5 mm with bleeding on probing following previous non-surgical periodontal treatment will be enrolled.
Residual periodontal pockets will be randomly assigned to one of the following groups:
Control group: repeated scaling and root planing alone Test group: repeated scaling and root planing combined with gaseous ozone application
Clinical periodontal measurements including plaque index (PI), gingival index (GI), bleeding on probing (BOP), probing depth (PD), recession depth (RD), and clinical attachment level (CAL) will be recorded using a standardized acrylic stent and a UNC-15 periodontal probe. Microbiological evaluation will be performed using the benzoyl-DL-arginine naphthylamide (BANA) enzymatic assay.
Ozone application will be performed using the OzoneDTA device with a periodontal probe tip according to the manufacturer's instructions. Clinical and microbiological evaluations will be performed at baseline, 3 months, and 6 months.
The primary objective of this study is to evaluate whether adjunctive ozone application improves clinical periodontal outcomes in residual periodontal pockets compared with repeated SRP alone.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Erzurum, Turchia (Türkiye)
- Ataturk University Faculty of Dentistry, Department of Periodontology
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
Inclusion Criteria:
- Systemically healthy individuals
- Patients diagnosed with stage III or IV periodontitis
- Patients undergoing periodontal maintenance therapy
- Presence of at least two residual periodontal pockets ≥5 mm with bleeding on probing
- Presence of radiographic bone loss ≥3 mm
- Plaque Index (PI) <1 before treatment
- Ability and willingness to attend all follow-up visits
- Written informed consent obtained
Exclusion Criteria:
- Presence of systemic diseases affecting periodontal healing
- Pregnancy or lactation
- Tobacco or alcohol use
- Use of medications affecting periodontal tissues or wound healing
- Periodontal treatment within the previous 6 months
- Presence of carious lesions or periapical pathology on selected teeth
- Furcation involvement
- Tooth mobility ≥ degree 1
- Restorations on selected teeth
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Comparatore attivo: Repeated Scaling and Root Planing
Residual periodontal pockets received repeated scaling and root planing alone following periodontal maintenance therapy.
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Repeated scaling and root planing of residual periodontal pockets was performed using mini-curettes under local anesthesia following periodontal maintenance therapy.
Altri nomi:
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Sperimentale: Repeated Scaling and Root Planing Plus Ozone
Residual periodontal pockets received repeated scaling and root planing combined with gaseous ozone application following periodontal maintenance therapy.
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Repeated scaling and root planing of residual periodontal pockets was performed using mini-curettes under local anesthesia following periodontal maintenance therapy.
Altri nomi:
Gaseous ozone was applied into residual periodontal pockets using the OzoneDTA device with a periodontal probe tip according to the manufacturer's instructions.
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change in Probing Depth
Lasso di tempo: Baseline, 3 months, and 6 months after treatment
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Assessment of changes in periodontal probing depth (PD) in residual periodontal pockets following repeated scaling and root planing with or without adjunctive gaseous ozone application.
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Baseline, 3 months, and 6 months after treatment
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change in Clinical Attachment Level
Lasso di tempo: Baseline, 3 months, and 6 months after treatment
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Assessment of changes in clinical attachment level (CAL) after periodontal treatment.
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Baseline, 3 months, and 6 months after treatment
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Bleeding on Probing
Lasso di tempo: Baseline, 3 months, and 6 months after treatment
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Assessment of bleeding on probing (BOP) in residual periodontal pockets following treatment.
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Baseline, 3 months, and 6 months after treatment
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BANA Test Results
Lasso di tempo: Baseline, 3 months, and 6 months after treatment
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Microbiological evaluation of red complex periodontal pathogens using the benzoyl-DL-arginine naphthylamide (BANA) assay.
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Baseline, 3 months, and 6 months after treatment
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Collaboratori e investigatori
Sponsor
Pubblicazioni e link utili
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Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie parodontali
- Malattie della bocca
- Malattie stomatognatiche
- Parodontite
- Tasca parodontale
- Sistema digestivo e fenomeni fisiologici orali
- Odontoiatria
- Fenomeni fisiologici dentali
- Ridimensionamento dentale
- Profilassi dentale
- Parodonzia
- Curettage subgeneivale
- Odontoiatria preventiva
- Piastrellatura radicale
- Esfoliazione dei denti
Altri numeri di identificazione dello studio
- ATAUNI-OZONEPOCKET-26
Piano per i dati dei singoli partecipanti (IPD)
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Descrizione del piano IPD
Informazioni su farmaci e dispositivi, documenti di studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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