NCT05066815

Brief Summary

The aim of the study is to evaluate the crestal bone loss developed around short dental implants after using screw retained Hybrid ceramic crowns when compare to screw retained Lithium Di silicate based ceramic crowns.

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
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2022

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

August 11, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 4, 2021

Completed
1.1 years until next milestone

Study Start

First participant enrolled

October 25, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2022

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

June 10, 2022

Status Verified

June 1, 2022

Enrollment Period

2 months

First QC Date

August 11, 2021

Last Update Submit

June 9, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Crestal Bone Loss Crestal bone loss will be measured using standardized digital periapical radiograph by paralleling technique and film holding device -measuring unit:Milimeters

    preventive

    one year

Secondary Outcomes (1)

  • screw loosening of crowns screw loosening will be observed by clinical investigation -measuring unit:Binary (Yes/No)

    one year

Study Arms (2)

Hybrid superstructure

EXPERIMENTAL

screw retained hybrid ceramic crowns

Other: Vita Enamic (Hybrid dental ceramic)

Ceramic superstructure

ACTIVE COMPARATOR

screw retained lithium disilicate based ceramic crowns

Other: Vita Enamic (Hybrid dental ceramic)

Interventions

Vita Enamic (Hybrid dental ceramic) is provided as blocks to be milled using Computer aided design/Computer aided manufacturer (CAD/CAM) technology.

Also known as: Polymer Infiltrated Ceramic Network (PICN)
Ceramic superstructureHybrid superstructure

Eligibility Criteria

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

You may qualify if:

  • Patients within age group of ≥ 18.
  • There should be absence of any systemic diseases.
  • Patients have missing simple posterior tooth
  • Adequate interarch space.
  • Inadequate residual bone height to place standard length implant.
  • Patients with good oral hygiene.

You may not qualify if:

  • A history that would complicate the outcome of the study, such as alcohol or drug dependency, smoking, poor health, or any other medical, physical or psychological reason that might affect the surgical procedure or the subsequent prosthodontics treatment and required follow-up.
  • Heavy smokers.
  • Poorly controlled diabetes mellitus.
  • Patients on radiotherapy.
  • Patients with temporomandibular disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Bone Diseases, Metabolic

Interventions

VITA Enamic

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
: Assistant Lecturer of Fixed Prosthodontics, Faculty of Dentistry (Aswan University)

Study Record Dates

First Submitted

August 11, 2021

First Posted

October 4, 2021

Study Start

October 25, 2022

Primary Completion

December 25, 2022

Study Completion

December 1, 2023

Last Updated

June 10, 2022

Record last verified: 2022-06