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

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.

Study Overview

• Status: Recruiting
• Conditions: Partial-edentulism
• Intervention / Treatment: Device: restored abutment (OPZAs); Device: restored abutment (TPZAs)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghao
    • Shanghai, Shanghao, China, 200001
      • Recruiting
      • =Shanghai Ninth People's Hospital, China
      • Contact: Xiaolei Lv, MD; Phone Number: 18817617580; Email: lyuxiaolei01@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. age≥18;
2. patients with two missing teeth in esthetic region and plan to be restored with two single implant crowns;
3. adjacent to natural teeth;
4. absence of oral mucosal disease and oral infection;
5. implants with conical connection (Nobel Active, Nobel Biocare® or NobelReplace Conical Connection, Nobel Biocare®);
6. patients with the willingness to participate in the present study.

Exclusion Criteria:

1. heavy smokers (>10 cigarettes/day);
2. uncontrolled periodontitis (Full mouth plaque score>20%, full mouth bleeding score>25%, residual pocket depth>5mm);
3. with systematic diseases that may affect implant therapy, such as uncontrolled diabetes mellitus (Fasting blood-glucose>7.2mmol/L, Glycosylated hemoglobin >7%), current intake of bisphosphonates (treatment for malignancy), pregnant(or plan to get pregnant), with history of radiation therapy in head and neck region.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: OPZAs group (OG); one-piece zirconia abutments (OPZAs)	Device: restored abutment (OPZAs); The restorations will be restored by the OPZAs
ACTIVE_COMPARATOR: TPZAs group (TG); two-piece zirconia abutments (TPZAs) with friction-fitted titanium bases	Device: restored abutment (TPZAs); The restorations will be restored with the TPZAs with friction-fitted titanium bases.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mechanical complications rates	Veneer chipping, abutments or implants fracture, screw loosening or fracture and other mechanical complications will be recorded during the 1-year follow-up.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival rates	The survival rate was defined as the percentage of success implants and remained crowns which never been replaced.	1 year
Peri-implant conditions-BOP%	peri-implant conditions included bleeding on probing% (BOP%)	1 year
Peri-implant conditions-PD	pocket probing depth (PD) in mm	1 year
Peri-implant conditions-mPI	modified plaque index (mPI).	1 year
Marginal bone loss (MBL)	Peri-apical radiographs with paralleling technique will be performed on the day of final restorations delivery and 1 year later. The implant length is used as calibration reference. The distance between restoration margin and the most coronal level of implant-bone contact will be recorded. The final result calculate as the mean value of mesial and distal sites. The alteration of the distance between baseline and 1-year follow-up is defined as the MBL.	1 year
Pro-inflammatory cytokines in peri-implant crevicular fluid (PICF)	We will collect the patients' PICF with the paper strip (PerioPaper Strips; Oraflow Inc., Smithtown, NY, USA) at 1-year follow-up to access differences in pro-inflammatory cytokines (IL-6 and TNF-α) between two groups. Enzyme-linked immunosorbent assay (ELISA) will be used to analyzed PICF and evaluated the concentrations of cytokines. The PICF collection method and cytokines determination referred to Christopher A. Barwacz et al.	1 year
PES	In this study, pink aesthetic score (PES) will be applied for the objective esthetic assessment of the final restoration. We will take patients' intraoral photos by the camera (D70, Nikon, Tokyo, Japan) at 1 year follow up. The aesthetic effect will be assessed by two specific dentists independently. They will asked to give scores for variables of PES (Mesial papilla, distal papilla, level of soft-tissue margin, soft-tissue contour, alveolar process and soft-tissue color and texture) and WES (Tooth form, tooth volume/outline, color, surface texture and transparency) with the 0-1-2 scoring system. Final PES/WES is the sum of the two.	1 year
WES	In this study, white esthetic score (WES) will be applied for the objective esthetic assessment of the final restoration. We will take patients' intraoral photos by the camera (D70, Nikon, Tokyo, Japan) at 1 year follow up. The aesthetic effect will be assessed by two specific dentists independently. They will asked to give scores for variables of PES (Mesial papilla, distal papilla, level of soft-tissue margin, soft-tissue contour, alveolar process and soft-tissue color and texture) and WES (Tooth form, tooth volume/outline, color, surface texture and transparency) with the 0-1-2 scoring system. Final PES/WES is the sum of the two.	1 year

Collaborators and Investigators

• Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 15, 2023
• Primary Completion (ANTICIPATED): December 1, 2023
• Study Completion (ANTICIPATED): December 1, 2023

Study Registration Dates

• First Submitted: March 6, 2022
• First Submitted That Met QC Criteria: October 12, 2022
• First Posted (ACTUAL): October 17, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 4, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: SH9th-20-12

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No