About this trial
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
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
1: Root canal retreatment of the affected tooth.
Trial design
Parallel
Treatments tested in this trial
modified endocrown
Procedure/SurgeryCombining the advantages of post-core crown and endocrown, an modified endocrown was designed
Treatment groups
Trial outcomes
Primary outcomes
survival rate
To evaluate secondary caries, proximal anatomy, gingival health, tooth integrity, marginal adaptability, fracture and retention, and radiographic results of the restoration, and to calculate FDI scores for the above indicators according to the World Dental Federation evaluation criteria (FDI), calculate the survival rate of the restoration
Secondary outcomes
Tooth reserve volume
After root canal treatment and before tooth preparation, each tooth was scanned by CEREC extraoral scanner before tooth preparation. Each tooth was scanned by CEREC extraoral scanner to obtain an original STL file A before tooth preparation. After tooth preparation, the original STL file A1 after tooth preparation was obtained. The files A and A1 were imported into reverse engineering software (GeomagicControlX2020; Geomagic Inc.), calculated and recorded the amount of tooth preparation tissue of each tooth, and finally statistically analyzed the amount of tooth preparation tissue of the two groups.
patient satisfaction
visual analogue scale,VAS
Adjust the amount of grinding tissue and the time of occlusal adjustment
After the prostheses are made, the prostheses are scanned by CEREC extraoral scanner, and each prosthesis will obtain an original STL file B, which will be bonded and fixed, adjusted, and scanned again by the same scanner to obtain the final STL file B1 of the prosthesis. The files B and B1 will be imported into reverse engineering software (Geomagic Control X2020; Geomagic Inc., calculated the adjustment tissue volume of the restoration, recorded the adjustment time during the operation, and finally analyzed the adjustment tissue volume and adjustment time of the two groups of restoration statistically.
Locations
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Sponsors and contacts
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Nanfang Hospital, Southern Medical University
Lead sponsor
Stomatological Hospital of Southern Medical University
Collaborator
Guanghua Stomatological Hospital, Sun Yat-sen University
Collaborator