Clinical Trial of Modified Endocrown and Personalized Post-core and Crown for Large-area Tooth Defects After Root Canal Treatment

NCT ID: NCT07206108

Last Updated: 2025-10-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 246 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-04
• Study Completion Date: 2029-12-31

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.

Conditions

Root Canal Infection; Tooth Defect; Post and Core Technique

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

modified endocrown

1. preparation of residual crown: A. occlusal surface reduction of about 1.5-2mm, hole edge angle rounded;B. root canal orifice extension: remove all decay, remove root canal filling material 2mm below the root canal orifice;C. pulp cavity wall formation: form 2-5° extension of the wall, if there is a concave with mobile resin restoration.

2. model design: use CEREC digital intraoral scanner

3. Cutting: using CEREC MCX CAD/CAM system, cutting lithium disilicate glass ceramic block (IPSe. max CAD), fitting modified pulp cavity retention crown on teeth, adjusting occlusion, post-treatment of restoration, bonding with all-acid etching resin cement.

Group Type: EXPERIMENTAL

modified endocrown

Intervention Type: PROCEDURE

Combining the advantages of post-core crown and endocrown, an modified endocrown was designed

Personalized pile core combined with full crown

1. Coronal preparation: Remove all existing restorations and carious tissue, eliminate unsupported enamel, flatten the root surface, establish the definitive margin, and ensure the dentin ferrule is ≥1 mm thick and ≥1.5 mm high.

2. Post-space preparation: Set post depth at ⅔-¾ of root length (≥ clinical crown length) using the working-length and periapical radiograph; remove obturation material to this depth with a pilot drill, leaving ≥4 mm apical seal.

3. Core restoration: Take a polyether impression of the post space, have a Co-Cr post-and-core fabricated, lute it with self-adhesive resin cement (RelyX U100/U200; 3M-ESPE), then prepare the core for a full crown.

4. Full-crown fabrication: Record a polyether impression/optical scan, have a lithium-disilicate ceramic crown (IPS e.max CAD) milled, try-in and adjust, then cement definitively with the same self-adhesive resin cement following manufacturer instructions.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

modified endocrown

Combining the advantages of post-core crown and endocrown, an modified endocrown was designed

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Stomatological Hospital of Southern Medical University

UNKNOWN

Sponsor Role: collaborator

Guanghua Stomatological Hospital, Sun Yat-sen University

UNKNOWN

Sponsor Role: collaborator

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Nanfang Hospital of Southern Medical University

China, , China

Site Status: RECRUITING

Countries

China

Facility Contacts

Wenjuan Yan

Role: primary

ywj918@smu.edu.cn

15802018770

Other Identifiers

NFEC-2025-270

Identifier Type: -

Identifier Source: org_study_id