- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07678125
Influence of Re-evaluation Timing After Phase I Periodontal Therapy on Clinical and Periodontal Outcomes.
Influence of Re-evaluation Timing After Phase I Periodontal Therapy on Clinical and Periodontal Outcomes. A Split-mouth Study
Periodontal disease remains a highly prevalent chronic inflammatory condition affecting the supporting structures of the teeth and is a leading cause of tooth loss worldwide. Contemporary periodontal therapy is structured into sequential phases, with non-surgical periodontal therapy (NSPT) forming the cornerstone of initial management. Following this phase, re-evaluation of periodontal status is critical to determine treatment outcomes and guide further intervention, including surgical therapy if required (1,2).
Re-evaluation phase serves multiple purposes: it allows assessment of tissue response to therapy, measurement of reductions in probing pocket depth (PPD), gains in clinical attachment level (CAL), and evaluation of patient compliance with oral hygiene practices. It also aids in identifying residual pockets or persistent inflammation that may necessitate additional treatment (1,3). Despite its clinical importance, the optimal timing of re-evaluation remains inconsistently defined in the literature (1). Generally, current literature utilizes a timing frame from 1-3 months; up to 9 months (3,4). Current clinical guidelines, including those from the European Federation of Periodontology (EFP), generally recommend assessing whether the end points have been achieved; no periodontal pockets ≥ 5mm with bleeding on probing and no pocket ≥ 6mm (5).
Emerging evidence suggests that certain clinical improvements, particularly reductions in inflammation and bleeding on probing (BOP), may occur as early as 4 weeks following therapy, raising questions about whether earlier re-evaluation could be clinically beneficial (2,3). Early reassessment may allow for more timely identification of non-responding sites, enabling prompt intervention and potentially improving overall treatment outcomes. Conversely, other studies indicate that full periodontal healing and maturation of tissues may require longer periods, supporting delayed re-evaluation intervals (1,2,3).
Furthermore, patient-related factors such as systemic health, smoking status, and baseline disease severity may influence healing dynamics and thus the appropriate timing for reassessment (1). The heterogeneity of these factors highlights the potential need for a more individualized approach to re-evaluation rather than a fixed universal timeframe.
Despite these considerations, there is a notable lack of high-quality comparative studies directly evaluating short-term versus conventional re-evaluation intervals following NSPT. Most available studies focus on treatment outcomes rather than the timing of reassessment itself. This creates a significant gap in the literature, particularly regarding whether earlier re-evaluation could enhance clinical decision-making, improve patient outcomes, or optimize resource utilization in clinical practice.
In addition, with increasing emphasis on minimally invasive and patient-centered care, there is a growing need to refine periodontal treatment protocols to ensure efficiency without compromising effectiveness. Determining the optimal timing of re-evaluation could contribute to improved treatment planning, reduced disease progression, and enhanced long-term periodontal stability.
Therefore, this study aims to address this gap by investigating the effectiveness and clinical implications of shorter re-evaluation intervals following periodontal therapy, compared to conventional timeframes.
Panoramica dello studio
Stato
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Nesma Shemais, PhD
- Numero di telefono: 0529961988
- Email: dr.nesma@gmu.ac.ae
Luoghi di studio
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Ajman Emirate
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Ajman, Ajman Emirate, Emirati Arabi Uniti, 00000
- Gulf Medical University
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
Inclusion Criteria:
- Patients above 18 yrs
- Patients that are systemically healthy
- Patients diagnosed as Stage III or Stage IV Periodontitis
- Patients willing to participate in the study and provide informed consent.
- Patients with no recent history of periodontal therapy
- Presence of ≥20 natural teeth
Exclusion criteria:
- Patients with a history of medical conditions or diseases that may affect healing or periodontal tissues.
- Patients who are pregnant
- Patients on Drugs/medication that may affect the periodontal tissue
- Smokers or tobacco users
- Patients that cannot complete the 12-week follow-up period
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Early Re-evaluation Group 4 weeks
Test group with periodontal re-evaluation at 4 weeks following non-surgical periodontal therapy.
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Test group with periodontal re-evaluation at 4 weeks following non-surgical periodontal therapy
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Comparatore attivo: Delayed Re-evaluation Group 10 - 12 weeks
Control group with periodontal re-evaluation at 8-10 weeks following non-surgical periodontal therapy
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Control group with periodontal re-evaluation at 8-10 weeks following non-surgical periodontal therapy
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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clinical attachment level
Lasso di tempo: baseline, 4 weeks, 10 weeks
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baseline, 4 weeks, 10 weeks
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
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probing depth
Lasso di tempo: baseline, 4 weeks, 10 weeks
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baseline, 4 weeks, 10 weeks
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Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
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
Altri numeri di identificazione dello studio
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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 .