NCT05583123

One-piece and Two-piece Zirconia Abutments in Single Implant Crowns in Esthetic Region

Evaluation of the One-piece Zirconia Abutments and Two-piece Zirconia Abutments With Titanium Bases for Single Implant Crowns in Esthetic Region: a Randomized Split-mouth Clinical Trial With 1-year Follow-up

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trail is to evaluate the clinical, radiological and immunological outcomes of the one-piece zirconia abutments (OPZAs) and two-piece zirconia abutments (TPZAs) with friction-fitted titanium bases in single implant crowns in aesthetic region. The main question it aims to answer is: whether the mechanical properties of one-piece zirconia abutments are the same as those of two-piece zirconia abutments. Participants who have two missing teeth in aesthetic region will receive the OPZAs for one restoration and the TPZAs for the other. Researchers will compare OPZAs group (OG) and TPZAs group (TG) to see the clinical, radiological and immunological outcomes of the two.

Detailed description

Objective: To evaluate the clinical, radiological and immunological outcomes of the one-piece zirconia abutments (OPZAs) and two-piece zirconia abutments (TPZAs) with friction-fitted titanium bases in single implant crowns in aesthetic region. Materials and methods: The study is a single center, split-mouth and randomized controlled clinical trial. Eligible sites of patients will be randomly assigned into two groups: OPZAs group (OG) and TPZAs group (TG). Survival rates, mechanical complication rates, bleeding on probing (BOP%), probing depth (PD), modified plaque index (mPI), marginal bone loss (MBL), concentrations of pro-inflammatory cytokines (TNF-α, IL-6) in peri-implant crevicular fluid (PICF), and pink esthetics score/white esthetics score (PES/ WES) will be evaluated. Discussion: Results of the present study will help to evaluate the clinical, radiological and immunological outcomes of OPZAs and TPZAs with friction-fitted titanium bases in single implant crowns in aesthetic region and provide evidence for the effects of two types abutments on the health of peri-implant soft and hard tissue.

Conditions

• Partial-edentulism

Interventions

Type	Name	Description
DEVICE	restored abutment (OPZAs)	The restorations will be restored by the OPZAs
DEVICE	restored abutment (TPZAs)	The restorations will be restored with the TPZAs with friction-fitted titanium bases.

Timeline

• Start date: 2023-01-15
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2022-10-17
• Last updated: 2023-02-08

Locations

1 site across 1 country: China