Actively Recruiting
Clinical Trial of Modified Endocrown and Personalized Post-core and Crown for Large-area Tooth Defects After Root Canal Treatment
Led by Nanfang Hospital, Southern Medical University · Updated on 2025-10-03
246
Participants Needed
1
Research Sites
230 weeks
Total Duration
On this page
Sponsors
N
Nanfang Hospital, Southern Medical University
Lead Sponsor
S
Stomatological Hospital of Southern Medical University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Clinical Trial of Modified Endocrown and Personalized Post-core and Crown for Large-area Tooth Defects After Root Canal Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- The affected tooth is a premolar that completed root canal treatment at least two weeks prior, with no abnormal periapical reactions by imaging and clinical exam.
- Good oral hygiene with no periodontitis or combined periodontal and endodontic lesions deeper than 4 mm.
- At least 50% of the crown structure remains, or at least two crown walls are preserved; the tooth defect is not located below the gums or can be aligned or exposed through crown lengthening surgery.
- The affected tooth has sufficient root length ensuring a pedicle-crown ratio of at least 1:1 and at least 3 mm of root tip closure.
- Normal occlusal function.
- Treated premolars are not used as abutments for fixed or removable partial denture restorations.
You will not qualify if you...
- Root canal retreatment of the affected tooth.
- Tooth loosening greater than grade I, or alveolar bone loss exceeding one-third of the root length.
- Loss of adjacent teeth or opposing teeth.
- Pregnancy or preconception period.
- Night bruxism, deep overbite, tight occlusion, severe limited mouth opening, or temporomandibular joint disorders.
- History of chemotherapy or radiotherapy to head and neck within 5 years; severe systemic or organic diseases; physical disabilities or mental illnesses affecting oral hygiene care; recent drug treatments affecting bone metabolism within 3 months.
- Imaging shows internal or external root absorption, or poor root/root canal anatomy unsuitable for pile-core crown restoration.
- Other conditions deemed unsuitable for participation by the researchers.
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Trial Site Locations
Total: 1 location
1
Nanfang Hospital of Southern Medical University
China, China
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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