Actively Recruiting
Multicenter Randomized Trial Comparing Modified Endocrown and Personalized Post-core with Full Crown for Large Tooth Defects After Root Canal Treatment
Led by Nanfang Hospital, Southern Medical University · Updated on 2025-10-03
246
Participants Needed
1
Research Sites
N/A
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
Researchers are evaluating two types of dental restorations for premolars with large tooth defects after complete root canal treatment. This multicenter, randomized controlled, single-blind trial aims to compare the survival rates of a modified endocrown restoration and a personalized post-core combined with a full crown. The study addresses a gap in clinical evidence for the modified endocrown and seeks to provide strong evidence for improving and standardizing dental restoration methods. Participants' treated premolars will be randomly assigned to one of two groups. One group will receive a modified endocrown restoration designed by combining the advantages of post-core crowns and endocrowns, using digital scanning and CAD/CAM cutting systems with lithium disilicate glass ceramic material. The other group will be restored with a personalized post-core and full crown, involving post-space preparation, core restoration with a cobalt-chromium post, and a lithium-disilicate ceramic crown. Both restoration procedures include detailed preparation and bonding techniques. Participants will have follow-up visits at 6 months, 1 year, and 2 years after treatment. Clinical and imaging examinations will evaluate the survival rates of the two restorations as the primary outcome. Additional assessments include measuring tooth reserve volume, patient satisfaction after 2 years, and the amount of grinding tissue and occlusal adjustment time immediately after restoration. The total participation duration is up to 2 years, with ongoing monitoring to assess restoration performance and patient experience.
CONDITIONS
Brief 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...
- Affected tooth is a premolar with complete root canal treatment done at least two weeks prior
- No abnormal periapical reactions based on imaging and clinical exams
- Good oral hygiene without periodontitis or periodontal-endodontic lesions with probing depth over 4mm
- No severe oral habits like heavy smoking or betel nut chewing
- At least 50% of the crown structure or at least two crown walls remain
- Tooth defect not below gums or can be aligned with gums or above gums with crown lengthening
- Sufficient root length to ensure a pedicle-crown ratio of at least 1:1 and root tip closure of at least 3 mm
- Normal occlusal function
- Treated premolars are not used as abutments for fixed or removable partial dentures
You will not qualify if you...
- Root canal retreatment of the affected tooth
- Tooth loosening greater than grade I and alveolar bone loss over one-third of root length
- Loss of adjacent or opposing teeth
- Pregnancy or planning pregnancy
- Night bruxism, deep overbite, tight occlusion, limited mouth opening, or temporomandibular joint diseases
- History of head and neck chemotherapy or radiotherapy within 5 years
- Severe systemic or organic diseases, physical disabilities, mental illnesses affecting oral hygiene care
- Recent drug treatment affecting bone metabolism within past 3 months
- Imaging signs of root absorption or poor root/root canal anatomy unsuitable for restoration
- Other situations deemed unsuitable by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Immediate treatment with procedures completed in one visit
Participants receive either a modified endocrown or a personalized post-core combined with a full crown to restore large tooth defects after root canal treatment.
1 treatment visit (in-person)
Duration - Up to 2 years
Participants are followed for up to 2 years to monitor the survival of the restoration and patient satisfaction.
Visits at 6 months, 1 year, and 2 years
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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