- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07662447
Clinical Evaluation of Platelet Rich Fibrin Membrane With or Without Hyaluronic Acid Along With Coronally Advanced Flap in the Treatment of Rt1 Gingival Recession
Gingival recession is a common mucogingival deformity that may result in root hypersensitivity, esthetic concern, plaque accumulation, and difficulty in oral hygiene maintenance. Modified coronally advanced flap procedures are widely used for Cairo RT1 gingival recession defects. Platelet-rich fibrin has been used as an autologous biologic adjunct, while hyaluronic acid has shown potential benefits in wound hydration, inflammation modulation, and soft tissue healing.
Aim: To evaluate the clinical effectiveness of multilayered platelet-rich fibrin with cross-linked hyaluronic acid compared with platelet-rich fibrin alone in the treatment of Cairo RT1 gingival recession defects using modified coronally advanced flap without vertical releasing incisions.
Panoramica dello studio
Stato
Condizioni
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
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:
Systemically healthy patients aged 18-50 years presenting with Cairo RT1 gingival recession defects were included in the study.
Patients were selected if the recession defect was present on a vital tooth with an identifiable cementoenamel junction and no interproximal clinical attachment loss.
The selected tooth was required to be free from caries, cervical restorations, non-carious cervical lesions interfering with measurement, pulpal pathology, and pathological mobility. Patients with acceptable oral hygiene after initial periodontal therapy, preferably with Plaque Index ≤1, were included.
Patients willing to participate in the study, sign informed consent, and report for all follow-up visits were included.
-Exclusion Criteria Patients were excluded if they were smokers or tobacco users, including smokeless tobacco users.
Patients with systemic conditions that could affect periodontal wound healing, such as uncontrolled diabetes mellitus, immunosuppressive disorders, bleeding disorders, connective tissue disorders, or any serious systemic illness, were not included. Pregnant or lactating women were excluded from the study.
Patients taking medications known to influence gingival healing, including corticosteroids, immunosuppressants, bisphosphonates, anticoagulants, or long-term anti-inflammatory drugs, were excluded. Patients with poor oral hygiene, untreated gingival inflammation, active periodontal disease, or recession defects classified as Cairo RT2 or RT3 were not included.
Teeth with cervical caries, cervical restorations, deep abrasion, erosion, non-carious cervical lesions interfering with CEJ identification, endodontic pathology, periapical lesions, non-vital pulp, traumatic occlusion that could not be corrected before surgery, or previous periodontal plastic surgery at the selected site within the past 12 months were excluded.
Patients undergoing orthodontic treatment or those who had recently completed orthodontic treatment were also excluded if tooth movement could affect gingival margin stability. Patients unwilling to provide consent or unable to attend the follow-up schedule were not included.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Comparatore attivo: root coverage with multilayered PRF
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root coverage with multilayered PRF
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Sperimentale: root coverage with multilayered PRF and hyaluronic acid
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root coverage with multilayered PRF and hyaluronic acid application
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Percentage of root coverage
Lasso di tempo: baseline, 3 months, 6 months
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baseline, 3 months, 6 months
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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postoperative pain VAS score 1-10
Lasso di tempo: baseline, 3 days, 3 weeks
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VAS score 1-10
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baseline, 3 days, 3 weeks
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Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
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
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- NoorMDSperio
Piano per i dati dei singoli partecipanti (IPD)
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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 .
Prove cliniche su root coverage with multilayered PRF
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Al-Mustansiriyah UniversityAttivo, non reclutanteParodontite | Perdita ossea alveolare | Tasca parodontaleIraq