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OpenTrials
Completed

NCT Number: NCT05500547

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

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.

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Key information

Conditions

Carious Teeth Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

25 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ruba Salah Anwar

Minya, 61511, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • • 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

Treatment and study plan

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

Other

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.

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

Primary outcomes

  1. USPSH criteria

    Time frame: For 9 months

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

Sponsors and collaborators

Lead sponsor

Minia University

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 15, 2022
Registry last updated
Aug 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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