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

Clinical Evaluation of a Moist Bonding Self-Adhering Flowable Composite With and Without Adhesive System Versus Conventional Flowable Composite in Cervical Caries Lesions: Randomized Clinical Trial

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.

Study Overview

• Status: Unknown
• Conditions: Dental Restoration Failure
• Intervention / Treatment: Other: flowable resin composite; Other: self adhering flowable; Other: self adhering flowable with adhesive

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt
    • Recruiting
    • Faculty of Dentistry Cairo university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 55 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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 ''	Other: flowable resin composite; gold standard; Other Names: conventional flowable composite
EXPERIMENTAL: self-adhering flowable; intervention one is moist bonding self adhering flowable composite that binds to tooth without an adhesive system	Other: self adhering flowable; moist bonding self adhering flowable composite; Other Names: embrace wet bond
EXPERIMENTAL: 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	Other: self adhering flowable with adhesive; moist bonding self adhering flowable composite with the aid of an adhesive system.; Other Names: embrace wet bond with adhesive

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the clinical performance using Fédération Dentaire Internationale' (FDI) World Dental Federation clinical criteria for the evaluation of the direct restoration. (FDI) criteria includes	Biological properties (Postoperative hypersensitivity & tooth vitality, Recurrence of caries, erosion & abfraction,Tooth integrity (enamel cracks or tooth fractures),Periodontal response (compared to a reference tooth),Adjacent mucosa, Oral & general health). Esthetic properties (Surface luster, Staining (surface &margin),Color match & translucency & Esthetic anatomical form). Functional properties (Fracture or material retention, Marginal integrity, Occlusal contour &wear (quantitatively & qualitatively), Proximal anatomical form(contact point &contour), Radiographic examination(when applicable) &Patient's view For each criteria one score will be chosen from 5 scores (excellent, good, satisfactory, unsatisfactory & poor). Subscales will not be combined	Change from the baseline at 6 months and12 months]

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 20, 2020
• Primary Completion (ANTICIPATED): February 1, 2021
• Study Completion (ANTICIPATED): June 1, 2022

Study Registration Dates

• First Submitted: February 12, 2019
• First Submitted That Met QC Criteria: February 27, 2019
• First Posted (ACTUAL): March 1, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 29, 2020
• Last Update Submitted That Met QC Criteria: October 27, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: Mon15

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No