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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Ho Chi Minh City, Vietnam
- Department of Orthodontics, Ho Chi Minh City Dental Hospital
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: Guided Apicoectomy With Retrograde Mineral Trioxide Aggregate Filling
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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.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Treatment Success Rate
Zeitfenster: 6 months after surgery
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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).
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6 months after surgery
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Number of Participants With Good Clinical Healing at 1 Week
Zeitfenster: 1 week after surgery
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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.
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1 week after surgery
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Number of Participants With Good Clinical Healing at 3 Months
Zeitfenster: 3 months after surgery
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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.
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3 months after surgery
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CBCT Bone Healing Score at 6 Months
Zeitfenster: 6 months after surgery
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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.
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6 months after surgery
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Number of Participants With Postoperative Complications
Zeitfenster: 1 week, 3 months, and 6 months after surgery
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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.
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1 week, 3 months, and 6 months after surgery
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Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: Lam N Le, Faculty of Odonto-Stomatology, Can Tho University of Medicine and Pharmacy
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- LeNguyenLam_CTUMP
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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