NCT07206108 Clinical Trial of Modified Endocrown and Personalized Post-core and Crown for Large-area Tooth Defects After Root Canal Treatment
| NCT ID | NCT07206108 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nanfang Hospital, Southern Medical University |
| Condition | Root Canal Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 246 participants |
| Start Date | 2025-08-04 |
| Primary Completion | 2029-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 246 participants in total. It began in 2025-08-04 with a primary completion date of 2029-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study intends to adopt a multicenter, randomized controlled, single-blind, non-inferiority clinical trial design. 246 premolars that meet the inclusion criteria after complete root canal treatment will be selected from the clinical practice and randomly divided into two groups. One group will be restored with the modified endocrown, and the other group will be restored with personalized post and core combined with full crown. Follow-up visits were conducted at 6 months, 1 year and 2 years after the operation respectively. Through clinical and imaging examinations, the survival rates of the two different restorations were evaluated and used as the main evaluation indicators to fill the gap in efficacy data of the modified endocrown in clinical applications, providing a strong evidence-based medical basis for subsequent restoration improvement and standardized application.
Eligibility Criteria
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.
Frequently Asked Questions
Who can join the NCT07206108 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Root Canal Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07206108 currently recruiting?
Yes, NCT07206108 is actively recruiting participants. Visit ClinicalTrials.gov or contact Nanfang Hospital, Southern Medical University to inquire about joining.
Where is the NCT07206108 trial being conducted?
This trial is being conducted at China, China.
Who is sponsoring the NCT07206108 clinical trial?
NCT07206108 is sponsored by Nanfang Hospital, Southern Medical University. The trial plans to enroll 246 participants.