NCT05583123

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 6, 2022

Completed
8 months until next milestone

First Posted

Study publicly available on registry

October 17, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

January 15, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

11 months

First QC Date

March 6, 2022

Last Update Submit

February 4, 2023

Conditions

Partial-edentulism

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Survival rates

    1 year

  • Peri-implant conditions-BOP%

    1 year

  • Peri-implant conditions-PD

    1 year

  • Peri-implant conditions-mPI

    1 year

  • Marginal bone loss (MBL)

    1 year

  • +3 more secondary outcomes

Study Arms (2)

OPZAs group (OG)

EXPERIMENTAL

one-piece zirconia abutments (OPZAs)

Device: restored abutment (OPZAs)

TPZAs group (TG)

ACTIVE COMPARATOR

two-piece zirconia abutments (TPZAs) with friction-fitted titanium bases

Device: restored abutment (TPZAs)

Interventions

restored abutment (OPZAs)DEVICE

The restorations will be restored by the OPZAs

OPZAs group (OG)
restored abutment (TPZAs)DEVICE

The restorations will be restored with the TPZAs with friction-fitted titanium bases.

TPZAs group (TG)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • heavy smokers (\>10 cigarettes/day);
  • uncontrolled periodontitis (Full mouth plaque score\>20%, full mouth bleeding score\>25%, residual pocket depth\>5mm);
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

=Shanghai Ninth People's Hospital, China

Shanghai, Shanghao, 200001, China

RECRUITING

Study Officials

  • Hongchang Lai, Professor

    Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiao-Lei Lv

CONTACT

86-18817617580lyuxiaolei01@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

March 6, 2022

First Posted

October 17, 2022

Study Start

January 15, 2023

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

February 8, 2023

Record last verified: 2023-02

Locations

CN(1)