NCT03521024

Brief Summary

aim of study is to evaluate esthetic and biomechanical outcome of maxillary anterior single-tooth zirconia implant supported PEKK crowns compared to lithium disilicate crowns on PEKK abutments .

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2018

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 26, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 11, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

September 15, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2019

Completed
Last Updated

May 11, 2018

Status Verified

May 1, 2018

Enrollment Period

9 months

First QC Date

April 26, 2018

Last Update Submit

May 8, 2018

Conditions

Tooth Loss

Keywords

Zirconia implantsPEKK crownshigh performance polymer crowns

Outcome Measures

Primary Outcomes (1)

  • Esthetic outcome

    measured by pink and white esthetics score

    9 month

Secondary Outcomes (1)

  • bone resorption

    9 month

Study Arms (2)

lithium disilicate crowns

ACTIVE COMPARATOR

lithium disilicate crowns are well documented in the literatures as successful restoration modality.

Other: poly ether ketone ketoneOther: lithium disilicate

poly ether ketone ketone crowns

EXPERIMENTAL

pekkton

Other: poly ether ketone ketoneOther: lithium disilicate

Interventions

poly ether ketone ketoneOTHER

Polyetherketoneketone (PEKK) forms a group of high-performance thermoplastic polymers. PEKK shows excellent biocompatibility and exhibits outstanding properties such as high wear resistance and high compressive (246 MPa), flexural (5.0GPa), and tensile strengths (115 MPa). The material is lightweight, allows shock absorption, and can be veneered with various commercially available dental materials

lithium disilicate crownspoly ether ketone ketone crowns
lithium disilicateOTHER

well documented in the literatures as successful restoration modality.

lithium disilicate crownspoly ether ketone ketone crowns

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age \>18 years
  • No active intraoral or systemic disease
  • No pregnancy or lactation
  • controlled periodontal conditions
  • Adequate bone volume to place an implant
  • Occlusal function with a natural tooth

You may not qualify if:

  • Current pregnancy.
  • Psychiatric disorders.
  • Smokers
  • Poor motivation.
  • Several occlusal parafunction.
  • Persistent intraoral infections.
  • Severe mucosal disease.
  • Active periodontitis.
  • Poor oral hygiene.
  • Lack of occluding dentition at implant rehabilitation level

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Tooth Loss

Interventions

poly(phthalazine ether sulfone ketone)lithia disilicate

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic DiseasesTooth Diseases

Study Officials

  • Lamiaa Abdelsalam, MSc

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

lamiaa Abdelsalam, MSc

CONTACT

201015833015dr.l.fadaly@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Patient will receive a restoration with superior function, esthetics, and quality.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

April 26, 2018

First Posted

May 11, 2018

Study Start

September 15, 2018

Primary Completion

June 15, 2019

Study Completion

September 15, 2019

Last Updated

May 11, 2018

Record last verified: 2018-05