Clinical Evaluation of Bioactive Injectable Resin Composite in Posterior Restorations

Clinical Evaluation of Bioactive Injectable Resin Composite Versus Conventional Nanohybrid Composite in Posterior Restorations, 18 m Randomized Controlled Clinical Trial

The aim of the study is to evaluate the clinical performance of new bioactive injectable composite compared to nanohybrid composite during the restoration of posterior cavities

Study Overview

• Status: Not yet recruiting
• Conditions: Dental Restoration Failure
• Intervention / Treatment: Other: Beautifil Flow Plus X F00 injectable composite; Other: Tetric N ceram resin composite

Detailed Description

Statement of the problem:

Marginal defects of composite fillings are often thought to be caused by poor adaptation of the restorative material to the cavity wall. To avoid these defects, particularly in posterior teeth, the use of flowable composites has been advocated because of their ability to 'wet' and adapt well to cavity margins and walls. However, flowable composites have a lower filler content and usually weaker mechanical properties than conventional composites.

The continued development of resin composites has led to formulations designed to further simplify the filling procedure, provide better mechanical properties, reduce the effect of polymerization shrinkage stresses and improve aesthetics. Recently, a new type of highly filled flowable composite has been developed. It is characterized by its high viscosity and is claimed to have improved mechanical properties not dissimilar from conventional composite restorative materials. This composite contains nano-sized filler particles, and due to its consistency, the material has been referred to as an 'injectable composite'.

Rationale for carrying out the trial:

The rationale of this study is to evaluate the mechanical performance of injectable composite resin against nanohybrid composites, because of its easy handling, time-saving, better margin adaptation, and the gain of extra mechanical properties at the same time.

• Study Type: Interventional
• Enrollment (Anticipated): 26
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hazem Elderiny, M.SC; Phone Number: +201007775636; Email: hazem.elderiny@dentistry.cu.edu.eg
• Study Contact Backup: Name: Yomna Khallaf, PhD; Phone Number: +201006781076; Email: Yomna.sayed@dentistry.cu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt
    • Faculty of Dentistry, Cairo University
    • Contact: Mai Mamdouh, PhD; Phone Number: +201066444572; Email: mai_mamdouh@dentistry.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 46 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Participants:

  1. Age range 20-50 years.
  2. Males Or females .
  3. Co-operative patients approving to participate in the trial.

• Teeth:

  1. class I or II carious lesions premolars and molars.
  2. Vital upper or lower teeth with no signs of irreversible pulpitis and pulpal necrosis.
  3. Presence of favorable occlusion and teeth are in normal contact with the adjacent teeth.

Exclusion Criteria:

• Participants:

  1. Patients with general systemic illness.
  2. Allergic history against any component of used material.
  3. Disabilities.
  4. Pregnancy
  5. Xerostomia.
  6. Lack of compliance.
  7. Evidence of parafunctional habits.
  8. Temporomandibular joint disorders.

• Teeth:

  1. Periapical pathology or signs of pulpal pathology.
  2. Endodontically treated teeth.
  3. Tooth hypersensitivity.
  4. Possible prosthodontic restoration of teeth.
  5. Heavy occlusion and occlusal contacts or history of bruxism.
  6. Severe periodontal affection.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: injectable composite; The material will be applied according to manufacturer instructions. BEAUTIFIL Flow Plus X will be applied directly into the cavity and create the shape desired in layers not exceeding 2 mm, and light cured for 20 seconds.	Other: Beautifil Flow Plus X F00 injectable composite; bioactive injectable composite
Active Comparator: Nanohybrid resin composite; The nanohybrid resin composite will be applied to the the cavity using the conventional incremental technique according to manufacturer instructions.	Other: Tetric N ceram resin composite; Nano hybrid resin composite

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the clinical performance	Measured using modified USPHS criteria	From baseline to 18 months

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Mai Mamdouh, PhD, Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2022
• Primary Completion (Anticipated): February 1, 2024
• Study Completion (Anticipated): March 1, 2024

Study Registration Dates

• First Submitted: August 11, 2022
• First Submitted That Met QC Criteria: August 11, 2022
• First Posted (Actual): August 12, 2022

Study Record Updates

• Last Update Posted (Actual): August 15, 2022
• Last Update Submitted That Met QC Criteria: August 11, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Injectable composite; Nano hybrid composite
• Other Study ID Numbers: Injectable resin composite

Drug and device information, study documents

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