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

NCT ID: NCT05500547

Last Updated: 2022-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-15

Study Completion Date

2022-07-15

Brief Summary

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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

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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.

Conditions

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Carious Teeth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Universal single shade resin composite restorative material

Dental restorative material

Group Type EXPERIMENTAL

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

Intervention Type 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.

Nano-hybrid multi-shade resin composite restorative material

Dental restorative material

Group Type ACTIVE_COMPARATOR

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

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Minia University

OTHER

Sponsor Role lead

Responsible Party

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Ruba Salah Anwar

Assistant Lecturer at Department of Operative Dentistry, Faculty of Dentistry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mona I Riad, Prof

Role: STUDY_DIRECTOR

Minia University

Locations

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Ruba Salah Anwar

Minya, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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RSAnwar

Identifier Type: -

Identifier Source: org_study_id

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