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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorNanfang Hospital, Southern Medical University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • modified endocrown

    Procedure/Surgery

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

Treatment groups

246 Participants
are divided into 2 treatment groups
Group A: modified endocrownExperimental treatment 1 intervention
Group B: Personalized pile core combined with full crownNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
6 month、1 year、2 years

Secondary outcomes

1

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.

Time frame
immediately
2

patient satisfaction

visual analogue scale,VAS

Time frame
2 years
3

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.

Time frame
immediately

Other outcomes

Locations

1

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Nanfang Hospital of Southern Medical UniversityRecruiting ChinaChinaChina

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nanfang Hospital, Southern Medical University

Lead sponsor

Stomatological Hospital of Southern Medical University

Collaborator

Guanghua Stomatological Hospital, Sun Yat-sen University

Collaborator