Clinical and Radiographic Characteristics and Outcomes of Guided Apicoectomy With Retrograde Mineral Trioxide Aggregate Filling for Periapical Cysts
Clinical and Radiographic Characteristics and Treatment Outcomes of Guided Apicoectomy With Retrograde Mineral Trioxide Aggregate Filling for Periapical Cysts in Premolar Teeth at Ho Chi Minh City Odonto-Stomatology Hospital
Patients with periapical cysts associated with premolar teeth often require apical surgery when conventional endodontic treatment cannot resolve the lesion. Guided apicoectomy using a three-dimensional surgical guide may improve surgical accuracy while minimizing bone removal and reducing the risk of damage to adjacent anatomical structures.
This prospective single-arm interventional study aims to evaluate the clinical and radiographic characteristics of premolar teeth with periapical cysts and assess the treatment outcomes of guided apicoectomy with retrograde Mineral Trioxide Aggregate (MTA) filling. Forty-two participants will be treated and followed for six months. Clinical healing and radiographic bone healing will be evaluated one week, three months, and six months after surgery.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Periapical cysts are common inflammatory lesions caused by pulpal infection and necrosis. Although conventional root canal treatment is effective in most cases, surgical intervention becomes necessary when persistent periapical lesions remain or true cysts develop.
Apicoectomy combined with retrograde filling using Mineral Trioxide Aggregate (MTA) has demonstrated high clinical success because of excellent sealing ability, biocompatibility, and stimulation of periapical tissue regeneration. Recently, computer-guided surgery integrating cone-beam computed tomography (CBCT), intraoral scanning, digital planning, and three-dimensional printing has improved surgical precision while minimizing unnecessary bone removal.
This prospective, single-center, single-arm interventional study will enroll 42 patients diagnosed with periapical cysts involving premolar teeth. Eligible participants will undergo guided apicoectomy, cyst enucleation, root-end cavity preparation, and retrograde filling with Mineral Trioxide Aggregate (MTA).
Clinical outcomes will be assessed one week, three months, and six months after surgery. Radiographic healing will be evaluated using cone-beam computed tomography (CBCT) at six months. The study aims to determine the effectiveness and safety of guided apicoectomy with MTA in treating premolar periapical cysts.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
-
Ho Chi Minh City, Vietnam
- Department of Orthodontics, Ho Chi Minh City Dental Hospital
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
Inclusion Criteria:
- Adults diagnosed with a periapical cyst involving a premolar tooth.
- Diagnosis confirmed by clinical examination and CBCT.
- Histopathological confirmation of periapical cyst after surgery.
- Root canal treatment completed with acceptable obturation quality.
- Tooth considered restorable.
- No previous apicoectomy on the study tooth.
- Able to provide written informed consent.
Exclusion Criteria:
- Uncontrolled systemic diseases.
- Coagulation disorders.
- Uncontrolled diabetes mellitus.
- Active malignancy receiving radiotherapy.
- Severe cardiovascular disease contraindicating surgery.
- Vertical root fracture.
- Grade IV tooth mobility.
- Allergy to local anesthetics or study materials.
- Previous surgery for recurrent periapical cyst at the study site.
- Inability to comply with follow-up schedule.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Guided Apicoectomy With Retrograde Mineral Trioxide Aggregate Filling
|
Patients undergo cone-beam computed tomography (CBCT) and intraoral scanning for digital treatment planning.
A three-dimensional surgical guide is fabricated to accurately locate the root apex.
Guided apicoectomy is performed with cyst enucleation, root-end resection, ultrasonic root-end cavity preparation, and retrograde filling using Mineral Trioxide Aggregate (MTA).
Standard postoperative medications and follow-up examinations are provided.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Treatment Success Rate
Lasso di tempo: 6 months after surgery
|
The treatment success rate will be assessed 6 months after surgery based on predefined clinical and radiographic success criteria.
Success is defined as the absence of clinical signs and symptoms together with evidence of bone healing on cone-beam computed tomography (CBCT).
|
6 months after surgery
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Number of Participants With Good Clinical Healing at 1 Week
Lasso di tempo: 1 week after surgery
|
Number of participants achieving good postoperative clinical healing according to the predefined postoperative evaluation criteria, including satisfactory wound healing without infection, wound dehiscence, excessive bleeding, or other clinically significant postoperative complications.
|
1 week after surgery
|
|
Number of Participants With Good Clinical Healing at 3 Months
Lasso di tempo: 3 months after surgery
|
Number of participants achieving good clinical healing based on the predefined clinical evaluation criteria, including the absence of pain, swelling, sinus tract, tenderness to percussion or palpation, and other signs of persistent periapical disease.
|
3 months after surgery
|
|
CBCT Bone Healing Score at 6 Months
Lasso di tempo: 6 months after surgery
|
Bone healing will be evaluated using cone-beam computed tomography (CBCT) according to the predefined CBCT healing criteria described in the study protocol.
Bone healing will be summarized using the CBCT healing score.
|
6 months after surgery
|
|
Number of Participants With Postoperative Complications
Lasso di tempo: 1 week, 3 months, and 6 months after surgery
|
Number of participants experiencing postoperative complications, including surgical site infection, wound dehiscence, persistent swelling, persistent pain requiring additional treatment, prolonged bleeding, paresthesia, or any surgery-related adverse event.
|
1 week, 3 months, and 6 months after surgery
|
Collaboratori e investigatori
Investigatori
- Investigatore principale: Lam N Le, Faculty of Odonto-Stomatology, Can Tho University of Medicine and Pharmacy
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
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- LeNguyenLam_CTUMP
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 .
Prove cliniche su Cisti periapicale
-
Ruby Hall IVF and Endoscopy CentreCompletatoTheca Lutein Cyst dell'ovaio sinistro