NCT03045900

Brief Summary

There is a deficiency in literature which compares the blending effect and color matching of translucent shade bulk-fill resin composite with shaded bulk-fill resin composite. So in this research color matching and blending effect will be instrumentally measured the by a spectrophotometer. A visual assessment also will be done in-vivo and ex-vivo.

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
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2017

Shorter than P25 for not_applicable

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

January 31, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 8, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2017

Completed
Last Updated

March 7, 2017

Status Verified

March 1, 2017

Enrollment Period

5 months

First QC Date

January 31, 2017

Last Update Submit

March 3, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • In-vivo visual color matching and blending effect by visual Score from 1 to 5

    Visual score from 1-5. The rank (1) is for mismatch or totally unaccepted, (2) is for poor match or hardly accepted, (3) is for good match or accepted, (4) is for close match or small difference, (5) is for exact match or no color difference

    Immediately in the same visit

Study Arms (2)

Translucent bulk-fill resin composite

ACTIVE COMPARATOR

\*Shaded bulk-fill resin composite. Bulk-fill resin composite which has no shade and could match any other shade. It will be compared for shade accuracy to the haded bulk-fill resin composite.

Other: Shaded bulk-fill resin composite

Shaded bulk-fill resin composite

EXPERIMENTAL

\*Translucent bulk-fill resin composite Bulk-fill resin composite which has a specific shade and should only be filled in teeth with the corresponding shade

Other: Shaded bulk-fill resin composite

Interventions

Dental bulk-fill resin composite with shades A1, A2, A3

Shaded bulk-fill resin compositeTranslucent bulk-fill resin composite

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • People with simple class I posterior teeth would be selected without any preference of age or gender.
  • Selected molars should only shaded A2, and A3 as these are shades under investigation.
  • Patients with multiple caries teeth are preferred.
  • Patients should be medically free and with good health.
  • Selected molars should be vital.
  • Patients should accept participation in the study.

You may not qualify if:

  • Very deep carious molars that are indicated for root canal treatment or pulp capping.
  • Teeth which are cracked, badly decayed crowns, non-restorable, periodontally affected, non-vital or abscessed.
  • Patients who refuse to accept participation or had psychological disturbance will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Design

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

Study Record Dates

First Submitted

January 31, 2017

First Posted

February 8, 2017

Study Start

April 1, 2017

Primary Completion

August 15, 2017

Study Completion

October 15, 2017

Last Updated

March 7, 2017

Record last verified: 2017-03