NCT04598737

Brief Summary

The aim of the present study is to assess the clinical performance of multilayered translucent zirconia laminate veneers versus lithium disilicate laminate veneers in terms of modified USPHS criteria for assessment of dental restorations (retention, restoration integrity, color match and marginal adaptation)

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
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2020

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

October 15, 2020

Completed
3 days until next milestone

Study Start

First participant enrolled

October 18, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 22, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
Last Updated

October 22, 2020

Status Verified

October 1, 2020

Enrollment Period

12 months

First QC Date

October 15, 2020

Last Update Submit

October 21, 2020

Conditions

Retention, Color Match, Marginal Adaptation and Restoration Integrity

Outcome Measures

Primary Outcomes (1)

  • Retention

    assessment of restoration will be done for retention on the base of of modified USPHS criteria for assessment of dental restorations

    12 months follow up period

Secondary Outcomes (1)

  • Restoration integrity

    12 months follow up period

Other Outcomes (2)

  • Color match

    12 months follow up period

  • Marginal adaptation

    12 months follow up period

Study Arms (2)

Ultra-translucent multilayer zirconia

EXPERIMENTAL

Ultra-translucent multilayer zirconia laminate veneer treatment

Procedure: Ultra-translucent multilayer zirconia

Lithium disilicate

EXPERIMENTAL

Lithium disilicate laminate veneer treatment

Procedure: Lithium disilicate

Interventions

Ultra-translucent multilayer zirconiaPROCEDURE

Ultra-translucent multilayer zirconia laminate veneer treatment

Ultra-translucent multilayer zirconia
Lithium disilicatePROCEDURE

Lithium disilicate laminate veneer treatment

Lithium disilicate

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • sufficient sound enamel thickness
  • Presence of one adjacent natural teeth that doesn't need laminate to compare shade
  • age range 20 to 40 years old
  • non smokers
  • diastema less than 2mm
  • tooth fracture not exceeding incisal one third
  • normal occlusion
  • vital teeth
  • healthy periodontal tissues

You may not qualify if:

  • insufficient enamel thickness
  • restoration more than 40 % of tooth surface
  • parafunctional habits
  • deep discoloration
  • sever teeth rotation
  • edge to edge or deep bite
  • abnormal occlusion
  • bad oral hygiene

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

lithia disilicate

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer

Study Record Dates

First Submitted

October 15, 2020

First Posted

October 22, 2020

Study Start

October 18, 2020

Primary Completion

October 1, 2021

Study Completion

November 1, 2021

Last Updated

October 22, 2020

Record last verified: 2020-10