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

Not Applicable

Completed

• Conditions: Carious Teeth
• Interventions: Other: US Public Health Service "USPSH" criteria for assessment of success of resin composite restorations

• Registration Number: NCT05500547
• Lead Sponsor: Minia University

Brief 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.

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.

Study Timeline

• Study Start: 2021-07-15
• Primary Completion: 2022-07-15
• Study Completion: 2022-07-15
• Study First Submitted: 2022-07-26
• Status Verified: 2022-08
• Study First Submitted QC: 2022-08-12
• Last Update Submitted: 2022-08-12
• Study First Posted: 2022-08-15
• Last Update Posted: 2022-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Universal single shade resin composite restorative material	US Public Health Service "USPSH" criteria for assessment of success of resin composite restorations	Dental restorative material
Nano-hybrid multi-shade resin composite restorative material	US Public Health Service "USPSH" criteria for assessment of success of resin composite restorations	Dental restorative material

Primary Outcome Measures

Name	Time	Method
USPSH criteria	For 9 months	Alpha and Beta are clinically successful, Charlie and Delta are clinically failure

Trial Locations

Locations (1)

Ruba Salah Anwar; 🇪🇬 Minya, Egypt