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

NCT05500547 | Completed

• 1 other identifier: RSAnwar
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Carious Teeth

Outcome Measures

Primary Outcomes (1)

• USPSH criteria

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

  For 9 months

Study Arms (2)

Universal single shade resin composite restorative material

EXPERIMENTAL

Dental restorative material

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

Nano-hybrid multi-shade resin composite restorative material

ACTIVE COMPARATOR

Dental restorative material

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

Interventions

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.

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

Nano-hybrid multi-shade resin composite restorative material; Universal single shade resin composite restorative material

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

Ruba Salah Anwar

Minya, 61511, Egypt

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Mona I Riad, Prof

  Minia University

  STUDY DIRECTOR

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: Assistant Lecturer at Department of Operative Dentistry, Faculty of Dentistry

Study Record Dates

• First Submitted: July 26, 2022
• First Posted: August 15, 2022
• Study Start: July 15, 2021
• Primary Completion: July 15, 2022
• Study Completion: July 15, 2022
• Last Updated: August 15, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

EG (1)