NCT03283280

Brief Summary

clinical performance of short fiber reinforced resin composite versus indirect nanohybrid resin composite onlay restorations in complex proximal cavities of molar teeth will be evaluated over one year.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2018

Geographic Reach
1 country

1 active site

Status
completed

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

September 11, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 14, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

February 1, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

July 25, 2019

Status Verified

July 1, 2019

Enrollment Period

1.3 years

First QC Date

September 11, 2017

Last Update Submit

July 24, 2019

Conditions

Dental Restoration Failure of Marginal Integrity

Keywords

Short fiber reinforced resin compositeNanohybrid resin compositeIndirect resin composite restoration

Outcome Measures

Primary Outcomes (1)

  • Change in the Clinical performance

    Measured using modified USPHS criteria for clinical evaluation of restoration failure

    Change from the Baseline at six months and 12 months.

Study Arms (2)

Short fiber RC

EXPERIMENTAL

Short fiber reinforced resin composite restoration (Ever X Posterior, Gc Europe) that is used in high stress bearing areas as direct onlay restoration.

Other: Ever X Posterior

Nanohybrid RC

ACTIVE COMPARATOR

Nanohybrid resin composite (GrandioSO, VOCO GmbH Germany ) that can be used to make indirect restorations in posterior teeth.

Other: Ever X Posterior

Interventions

Ever X PosteriorOTHER

Resin composite restoration can be made as a direct onlay

Also known as: Short fiber reinforced resin composite
Nanohybrid RCShort fiber RC

Eligibility Criteria

Age16 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Pulp asymptomatic vital carious upper or lower molars.
  • Proximal complex carious cavities involving one or two weak cusps.
  • Replacement of old amalgam or resin composite restoration due to recurrent caries or either tooth or restoration fracture.
  • Presence of favorable occlusion.
  • Healthy volunteers

You may not qualify if:

  • Teeth with signs and symptoms of irreversible pulpitis or pulp necrosis.
  • Deep subgingival cavity margins.
  • Possible future prosthodontic restoration of teeth.
  • Severe periodontal problems.
  • Medically compromised patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry

Cairo, 11331, Egypt

Location

Related Links

Study Officials

  • Rawda Hesham Abd ElAziz, Msc

    Assistant lecturer

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcome assessors will be blinded to the material type
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

September 11, 2017

First Posted

September 14, 2017

Study Start

February 1, 2018

Primary Completion

June 1, 2019

Study Completion

July 1, 2019

Last Updated

July 25, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)