Modified endocrown versus personalized post-and-core plus full crown for large premolar defects after root canal

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, randomized, single-blind non-inferiority trial enrolling 246 premolars that have completed root canal treatment. Eligible teeth will be randomized to receive either a modified endocrown restoration or a personalized post-and-core combined with a full crown, using clinical and imaging guidance and CAD/CAM workflows where applicable. Participants will be followed at 6 months, 1 year, and 2 years to record clinical and radiographic outcomes, with the primary outcome being restoration survival rate. The trial aims to provide comparative efficacy and safety data to guide restorative choices for large-area premolar defects after endodontic therapy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 1: The affected tooth was a premolar that had undergone complete root canal treatment for two weeks. Both imaging and clinical examinations indicated no abnormal periapical reactions.

  2: The oral hygiene condition is good. There is no periodontitis or combined periodontal and endodontic lesions with a probing depth greater than 4mm. There are no severe oral bad habits (such as smoking more than 20 cigarettes per day, chewing betel nuts, etc.)

  3: At least 50% of the crown structure should be retained, or at least two crown walls should be retained, and the tooth defect should not be located under the gums or can be aligned with the gums or located above the gums through crown lengthening surgery.

  4: The affected tooth has sufficient root length to ensure a pedicle-crown ratio of at least 1:1 and a root tip closure of at least 3 mm.

  5: The occlusal function is normal.

  6: Treated premolars will not be used as abutments for FPD or RPD restoration.

Exclusion Criteria:

* 1: Root canal retreatment of the affected tooth.

  2: Loosening \> I °, alveolar bone resorption exceeds 1/3 of the root length.

  3: Loss of adjacent teeth and occlusal teeth.

  4: The patient is in the preconception period and the pregnancy period.

  5: Patients with night bruxism, deep overbite, tight occlusion or severe limited mouth opening, and temporomandibular joint diseases.

  6: Patients who have a history of chemotherapy or radiotherapy in the head and neck region within 5 years, suffer from severe systemic and organic diseases, have physical disabilities or mental illnesses that affect oral hygiene care, or have received drug treatment that may affect or promote bone metabolism within the past 3 months.

  7: The affected tooth has imaging manifestations of absorption inside and outside the root, or the anatomical morphology of the root and root canal is poor, such as short and small roots, curved root canals, small roots or residual roots that cannot meet the cord-to-root ratio standard for pile-core crown restoration.

  8: The researchers consider other situations that are not suitable for participation.

Where it's running

• Nanfang Hospital of Southern Medical University
  China, China Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Antibacterial Effect of Bioceramic vs Calcium Hydroxide Medicaments in Root Canals

  This study tests whether Bio-C Temp or UltraCal XS can better reduce bacteria inside root canals of lower molars with chronic apical periodontitis.

  Recruiting Medipol University · Istanbul, Istanbul · NCT07671326

• Chitosan irrigation for mandibular premolar root canal treatment

  This test compares three common root-canal rinses to see which one best reduces bacteria in adults needing a premolar root canal.

  Recruiting Ordu University · Ordu, Altınordu · NCT07048028

• Assessing long-term dental effects of chemotherapy in childhood cancer survivors

  This study looks at the long-term dental health of childhood cancer survivors who had chemotherapy to see if they have more dental problems compared to kids who didn’t have cancer.

  Recruiting Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Brussels · NCT06517927

• Evaluating one versus two visits for root canal retreatment outcomes

  This study is testing whether having a root canal retreatment done in one visit or two visits works better for people with certain dental issues.

  Recruiting Universitat Internacional de Catalunya · Sant Cugat del Vallès, Barcelona · NCT04527705

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.