- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07323433
Efficacia di una medicazione in chitosano nella pulpotomia di denti permanenti immaturi
Efficacia di una medicazione in Chitosano nella Pulpotomia di Denti Permanenti Immaturi: Studio Clinico Randomizzato
Immature permanent teeth, also known as young permanent teeth, are used to describe teeth with incomplete root formation. Immature permanent teeth are prone to caries and trauma which can cause exposure and degeneration of pulp. Pulp degeneration stops root formation, leaving teeth with open apex. It is vital to preserve the pulp vitality otherwise the incompletion of root might result in the fragility of teeth. Pulpotomy is one of the most widely used methods in preserving vital pulp in teeth, which is of great significance in achieving continue root formation in immature permanent teeth suffering from dental caries or trauma. Pulpotomy is recommended by the American Association of Pediatric Dentistry for the management of pulp exposure in immature permanent teeth to achieve apexogenesis (continued root formation and closure of apex). In this procedure, coronal pulp tissue is removed in order to eliminate the infected or contaminated pulp and to reach the healthy vital pulp followed by coverage with biocompatible material.
Panoramica dello studio
Descrizione dettagliata
Immature permanent teeth, also known as young permanent teeth, are used to describe teeth with incomplete root formation. Immature permanent teeth are prone to caries and trauma which can cause exposure and degeneration of pulp. Pulp degeneration stops root formation, leaving teeth with open apex. It is vital to preserve the pulp vitality otherwise the incompletion of root might result in the fragility of teeth. Pulpotomy is one of the most widely used methods in preserving vital pulp in teeth, which is of great significance in achieving continue root formation in immature permanent teeth suffering from dental caries or trauma. Pulpotomy is recommended by the American Association of Pediatric Dentistry for the management of pulp exposure in immature permanent teeth to achieve apexogenesis (continued root formation and closure of apex). In this procedure, coronal pulp tissue is removed in order to eliminate the infected or contaminated pulp and to reach the healthy vital pulp followed by coverage with biocompatible material.
Clinically, the characteristic and the extent of pulpal hemorrhage at the exposure site are the most important outcome predictors for assessing pulpal status.
reported that excessive bleeding from the pulp revealed a significantly lower incidence of success compared with moderate bleeding. A variety of solutions and methods have been used to obtain pulpal hemostasis. Despite its limited effect on pulpal healing, sterile saline is a frequently used agent. Sodium hypochlorite (NaOCl), in concentrations of 0.5percent, achieves hemostasis without affecting pulpal repair mechanism and healing.
Hemostatic dressings have emerged as valuable adjuncts in dentistry, offering effective and efficient control of bleeding during various dental procedures. The different types of hemostatic dressings, including oxidized cellulose, gelatin- based, chitosan, and calcium-based dressings, provide localized hemostasis, reduce chair time, and improve patient outcomes.
Recently, the concept of lesion sterilization and tissue repair therapy involve the use of a mixture of antibacterial drugs for disinfection. Repair of damaged tissues can be expected if lesions are disinfected.
Chitosan is a natural and non-toxic polysaccharide with unique biological properties such as antimicrobial, anti- fungal, anti-inflammatory, antiseptic, antitumor, hemostatic,
immune adjuvant, regenerative effect and wound healing. In dentistry, it can be used as a dental pulp capping material, mouth rinse, chewing gum, drug device for root canal disinfection, topical treatment of periodontitis and blood hemostasis after tooth extraction.
Chitosan is the most abundant biopolymer on the earth derived from chitin. It shows a remarkable effective broad spectrum antibacterial action attributed to its cationic nature. It interacts with the -ve charged bacterial cell membranes, leading to leakage of the intracellular constituents and ultimately cell death due to increasing the membrane permeability. Also, chitosan possesses a variety of other biological properties as being biodegradable, biocompatible.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
-
Minya, Egitto
- Minia University Hospital
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Patients with immature maxillary anterior teeth.
- Patients with caries or traumatic exposed teeth .
- Patients should be free from any systemic disease that may affect normal healing and predictable outcome class I ASA .
- Patients who will agree to the consent and will commit to follow-up period.
Exclusion Criteria:
- Patients with mature roots.
- Patients with any systemic disease that may affect normal healing.
- Patients with signs of periapical inflammation.
- Patients who could/would not participate in a 1-year follow-up.
- Teeth with periodontal involvement.
- Teeth with vertical root fractures.
- Non- restorable teeth.
- cases with previously initiated endodontic treatment.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore attivo: Group Hemcon Dressing
About 13 Participants presented with traumatic or caries exposed upper anterior teeth with immature root and they will be subjected to Application of Hemcon Dressing as A dressing material for hemostasis on pulp stump during pulpotomy of the immature teeth. |
To evaluate the effect of chitosan dressing in pulpotomy of immature permanent teeth
Altri nomi:
|
|
Comparatore attivo: Group of Cotton damped with normal saline
About 13 Participants presented with traumatic or caries exposed upper anterior teeth with immature root and they will be subjected to Application of cotton damped with normal saline for hemostasis on pulp stump during pulpotomy of the immature teeth. |
To evaluate the effect of chitosan dressing in pulpotomy of immature permanent teeth
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Post Operative Pain
Lasso di tempo: 72 Hours
|
Assessment of the post operative pain via Numerical Pain Rating Scale (NRS) where the level of pain will be recorded as follows: 0 reading represents "no pain" ; 1- 3 reading represents "mild pain" ; 4- 6 reading represents "moderate pain" and 7- 10 reading represents "severe pain". |
72 Hours
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Assessment of root completion
Lasso di tempo: at 6 and 12 months
|
Assessment of root completion using standardized periapical radiograph at 6 and 12 months\periods. |
at 6 and 12 months
|
Collaboratori e investigatori
Sponsor
Investigatori
- Cattedra di studio: Lamiaa Ahmed Ebrahem, Professor, Department of endodontics Dean of Faculty of Dentistry Fayoum University
Studiare le date dei record
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
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- Chitosan Dressing
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
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 .