Chronic apical periodontitis
Conditions
Interventions
A1 Group:Application of C-Root BP for retrograde filling in apical surgery
A2 Group:Application of iRoot BP Plus for retrograde filling in apical surgery
A3 Group:Application of ProRoot MTA for retrograde filling in apical surgery
B1 Group:Application of C-Root BP for pulp capping in pulpotomy
B2 Group:Application of iRoot BP Plus for pulp capping in pulpotomy
B3 Group:Application of ProRoot MTA for pulp capping in pulpotomy
Sponsors
The First Medical Center, Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
6 Years to 60 Years
Inclusion criteria
Inclusion criteria: Study 1 (Apical Surgery RCT): (1) Patients aged 18 to 60 years without major systemic diseases who can cooperate with surgical treatment and postoperative long-term follow-up; preoperative X-ray and CBCT examinations are performed. (2) Periapical cyst (single-root periapical cyst size <=8 mm in diameter). (3) Iatrogenic periapical lesions (e.g., overfilling of root canal, separated instrument, root canal deviation, lateral perforation, etc.). (4) Inability to complete root canal treatment/retreatment (e.g., calcified blockage in the apical region, post-and-core crown restoration, etc.). (5) Localized horizontal root fracture or cemental tear (periapical radiolucency area <=8 mm in diameter). (6) Chronic apical periodontitis deemed as treatment failure after non-surgical retreatment with follow-up exceeding 6 months, based on clinical examination and imaging findings (including recurrent swelling and pain, persistent sinus tract, no significant reduction in periapical radiolucency, etc.). Study 2 (Pulpotomy RCT): (1) Patients aged 6 to 14 years without systemic diseases who can cooperate with treatment; preoperative periapical radiographs or panoramic radiographs are taken to record root development status. (2) Preoperative clinical diagnosis of carious chronic pulpitis in immature permanent teeth: The affected tooth may present with food impaction pain and occlusal discomfort, spontaneous pain, but no radiating pain or history of gum swelling and pain; deep carious cavity, obvious probing pain or exposure of the pulp chamber and pulp can be detected, without root fracture or displacement, no percussion pain or percussion pain (+/-), no mobility, and pulp temperature testing shows delayed pain lasting several seconds to minutes. Preoperative imaging confirms immature permanent teeth with open apices, showing caries approaching or involving the pulp, intact and continuous periodontal ligament space (with possible widening), no periapical radiolucency, no internal or external root resorption, and no pulp chamber calcification. (3) During the procedure, after complete caries removal, pulp exposure occurs, and formed pulp tissue is visible. Hemostasis can be achieved within 10 minutes after pulpotomy. In deep carious teeth without typical clinical manifestations of pulpitis, when pulp exposure occurs after complete caries removal or even before complete caries removal, it should be diagnosed as "chronic pulpitis". In this study, all postoperative diagnoses are "chronic pulpitis".
Exclusion criteria
Exclusion criteria: Study 1 (Apical Surgery RCT): (1) Patients with systemic diseases, allergy to local anesthetics or multiple drugs, or other absolute contraindications to treatment; (2) Pregnant patients; (3) Patients with malignant tumors, or those who have taken oral or injectable bisphosphonates; (4) Patients with extreme dental fear and psychological disorders who are unable to understand, cooperate, or complete the treatment; (5) Tooth mobility greater than grade I, or combined periodontal-endodontic lesions; (6) Presence of separated instruments, root fracture, or root split in the affected tooth; (7) Incomplete root development, with open or destroyed apical foramen; (8) Excessive orbicularis oris muscle tension or mouth opening less than three finger widths, preventing accurate intraoperative manipulation of instruments. Study 2 (Pulpotomy RCT): (1) Patients with systemic diseases or allergy to local anesthetics or any medications used in the study; (2) Preoperative periapical radiograph showing periapical lesions and no response to electric pulp testing; (3) Intraoperative observation of non-formed pulp or necrosis extending to the radicular pulp; (4) Inability to achieve hemostasis within 10 minutes of sterile cotton pellet pressure after pulp amputation; (5) Carious lesion extending beyond two-thirds of the crown, compromising adequate retention and resistance for subsequent restoration; (6) Inability to cooperate with postoperative follow-up examinations within 12 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| periapical Index; | — |
Secondary
| Measure | Time frame |
|---|---|
| postoperative pain response;postoperative success rate;electric pulp test value; | — |
Countries
China
Contacts
Public ContactFei Chen
The First Medical Center, Chinese PLA General Hospital
Outcome results
None listed