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CompletedNCT05500547Updated Aug 15, 2022

Clinical Performance of One-shade Universal Dental Resin Composite as Posterior Restoration

An interventional study of US Public Health Service "USPSH" criteria for assessment of success of resin composite restorations in Carious Teeth, sponsored by Minia University. Completed at 1 site in Egypt. Open to participants aged 25 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-08-15.

Sponsored by Minia University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Jul 2021, registered Jul 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
25 Years to 45 Years
Sex
All
01

Study summary

This study is aimed to evaluate the clinical performance of new One-shade universal composite resin as posterior restoration using US Public Health Service "USPSH" criteria for color match, marginal adaptation, surface texture, retention, recurrent caries and others after 1, 3, 6 and 9 months.

Read the detailed description

One operator will place all restorations under rubber-dam isolation. The patients will receive restorations with both materials, randomly after shade selection (The shade of single shade universal resin composite "Omnichroma" will be taken before and after placement into the cavity). During the referred period, only the two composites in study will be placed in posterior teeth in the dental office. The various materials' application procedure will be applied according to manufacturer's instructions.

02

Conditions studied

  • Carious Teeth

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03

In context

Dental Caries

1,109 studies on the registry are indexed under Dental Caries; 197 are open to participants now.

This study's enrollment of 40 is below the median of 60 across 916 interventional studies indexed under Dental Caries.

Browse Dental Caries studies →

Lead sponsor

Minia University is the lead sponsor of 356 studies on the registry; 115 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

    • They should have an acceptable oral hygiene level.

      • Presence of at least two occlusal carious lesions to be restored with two different types of composite.
      • The two studied materials restorations should be used in approximately the same sized lesions or within the same extension.
      • Age range between 25 and 45years.

Exclusion criteria

Exclusion Criteria:

    • Severe or active periodontal or carious disease and heavy bruxism or a traumatic occlusion

      • Patients with a compromised medical history, or had received therapeutic irradiation to the head and neck region.
      • Alcoholic and smoker patients.
      • Patients had participated in a clinical trial within 6 months before commencement of this trial.
      • Patients unable to return for recall appointment
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Universal single shade resin composite restorative material

    Dental restorative material

    Other: US Public Health Service "USPSH" criteria for assessment of success of resin composite restorations

  • Active comparator
    Nano-hybrid multi-shade resin composite restorative material

    Dental restorative material

    Other: US Public Health Service "USPSH" criteria for assessment of success of resin composite restorations

Interventions

  • OtherUS Public Health Service "USPSH" criteria for assessment of success of resin composite restorations

    US Public Health Service "USPSH" criteria for color match, marginal adaptation, surface texture, retention, recurrent caries and others after 1, 3, 6 and 9 months.

    Also known as: assessment of Universal single shade resin composite and Nano-hybrid multi-shade resin composite restorative material using the US Public Health Service "USPSH" criteria

06

What researchers measure

Primary outcomes

  1. USPSH criteria

    Alpha and Beta are clinically successful, Charlie and Delta are clinically failure

    Time frame: For 9 months

07

Study locations

1 site
  • Ruba Salah Anwar
    Minya, 61511, Egypt
08

References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 15, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05500547
Lead sponsor
Minia University
Responsible party
Ruba Salah Anwar (Assistant Lecturer at Department of Operative Dentistry, Faculty of Dentistry, Minia University) — Principal investigator
First posted
Aug 15, 2022
Start date
Jul 15, 2021
Primary completion
Jul 15, 2022
Completion
Jul 15, 2022
Last update
Aug 15, 2022

Study contacts

Mona I Riad, Prof
study director · Minia University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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