Evaluation of Adhering Flowable Composite With and Without Adhesive Vs Flowable in Cervical Lesions

NCT ID: NCT03859284

Last Updated: 2020-10-29

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-20

Study Completion Date

2022-06-01

Brief Summary

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With limited evidence-based information in literature about using self-adhering flowable composite in conservative class V restorations, it was found beneficial to evaluate the newly introduced material using a randomized controlled clinical trial to test the null hypothesis that moist bonding self-adhering flowable composite with and without adhesive system will have the same clinical performance as conventional flowable composite in cervical caries lesions.

Detailed Description

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flowable composite is considered a gold standard in class V restorations due to its resilient character the prevents its dislodgement in this area. self-adhering flowable composite would simplify the clinical steps and claims to improve the adhesion.

Conditions

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Dental Restoration Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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flowable resin-composite

3M flowable composite is a conventional restoration to treat anterior carious cervical lesions. considered to be the gold standard of the flowable composites.

other names: ''flowable composite ''

Group Type ACTIVE_COMPARATOR

flowable resin composite

Intervention Type OTHER

gold standard

self-adhering flowable

intervention one is moist bonding self adhering flowable composite that binds to tooth without an adhesive system

Group Type EXPERIMENTAL

self adhering flowable

Intervention Type OTHER

moist bonding self adhering flowable composite

self-adhering flowable with adhesive

intervention two moist bonding self adhering flowable composite that binds to tooth with the aid of adhesive system to improve the clinical performance

Group Type EXPERIMENTAL

self adhering flowable with adhesive

Intervention Type OTHER

moist bonding self adhering flowable composite with the aid of an adhesive system.

Interventions

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flowable resin composite

gold standard

Intervention Type OTHER

self adhering flowable

moist bonding self adhering flowable composite

Intervention Type OTHER

self adhering flowable with adhesive

moist bonding self adhering flowable composite with the aid of an adhesive system.

Intervention Type OTHER

Other Intervention Names

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conventional flowable composite embrace wet bond embrace wet bond with adhesive

Eligibility Criteria

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Inclusion Criteria

* patients with anterior cervical carious lesions.
* Pulp asymptomatic vital carious anterior teeth.
* Co-operative patients approving to participate in the trial.

Exclusion Criteria

* Pregnancy.
* Disabilities.
* Systemic disease or severe medical complications.
* Deep extensive carious cavities that may lead to the fracture of the tooth or pulpal affection.
* Teeth with signs and symptoms of irreversible pulpitis or pulp necrosis.
* Heavy smokers.
Minimum Eligible Age

16 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Mona Mounir Ibrahim Hassan

assistant lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Dentistry Cairo University

Giza, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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mona mounir, msc

Role: CONTACT

01001171585

hussein gomaa, PhD

Role: CONTACT

Facility Contacts

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faculty of dentistry

Role: primary

Other Identifiers

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Mon15

Identifier Type: -

Identifier Source: org_study_id