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

Carious Teeth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05500547
• Other study ID #: RSAnwar
• Status: Completed
• Phase: N/A
• Start date: July 15, 2021
• Est. completion date: July 15, 2022

Study information

• Verified date: August 2022
• Source: Minia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 15, 2022
• Est. primary completion date: July 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Carious Teeth
• Dental Caries

Intervention

Other:
• US 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.

Locations

Country	Name	City	State
Egypt	Ruba Salah Anwar	Minya

Sponsors (1)

Lead Sponsor	Collaborator
Minia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	USPSH criteria	Alpha and Beta are clinically successful, Charlie and Delta are clinically failure	For 9 months