Clinical Evaluation of Fiber Reinforced Resin Composite Base Versus Incremental Packing of Nanohybrid Resin Composite

NCT04019145 | Completed Early Phase 1 DMC

• 1 other identifier: 28909092104862
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

A clinical trial, comparing two different incrementation techniques in the restoration of proximal caries in permanent posterior teeth . One utilizes a fiber reinforced bulk fill base material, followed by an occlusal nanohybrid capping layer. The other utilizes incremental packing of nanohybrid resin composite material to fill the whole cavity.

Conditions

Caries Class II

Outcome Measures

Primary Outcomes (1)

• Mechanical outcome according to USPHS criteria

  fracture or retention, marginal integrity, marginal discoloration, anatomic form, proximal contact, radiographic examination and surface texture

  12 months

Secondary Outcomes (1)

• Biological outcome according to USPHS criteria

  12 months

Study Arms (2)

Fiber Reinforced bulk fill resin composite

EXPERIMENTAL

Fiber reinforced bulk fill resin composite dentine substitute, capped occlusally and proximally (closed centripetal technique) by nanohybrid resin composite.

Drug: EverX Posterior

nanohybrid resin composite incrementation

ACTIVE COMPARATOR

Nanohybrid resin composite layering to fill the whole cavity, using closed centripetal technique.

Drug: Resins, Composite

Interventions

EverX Posterior DRUG

fiber reinforced bulk fill resin composite

Also known as: Fiber reinforced bulk fill dentine substitute

Fiber Reinforced bulk fill resin composite

Resins, Composite DRUG

incremental packing of Nanohybrid Resin composite

Also known as: Universal Restorative Nanohybrid resin composite

nanohybrid resin composite incrementation

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patient-related criteria:
• Patients consulting in one of the outpatient clinic listed above.
• Able to tolerate necessary restorative procedures.
• Provide informed consent.
• Accepts the one year follow-up period.
• Tooth related criteria:
• Teeth with primary deep carious lesions involving 2/3 of the entire dentin thickness with no continuity between the carious cavity and the pulp chamber.
• Teeth are vital according to pulp-sensitivity tests.

You may not qualify if:

• Patient-related criteria:
• Medically compromised patients, as they will not be able to attend multiple appointments or may require special management.
• Pregnant women; as radiographs cannot be taken for them.
• Allergy to any of the restorative materials, including anesthetics.
• Uncooperative patients, will not abide by the instructions or attend the appointments.
• Tooth related criteria:
• Deciduous teeth; as the study is targeting only permanent teeth.
• Teeth with previous restorations, which may add another variable to the study (type of old restorative material, extent of recurrent caries).
• Spontaneous pain or prolonged pain after sensitivity tests (cold and electrical tests), which would indicate irreversible pulpal damage.
• Negative sensitivity tests, periapical radiolucencies and sensitivity to axial or lateral percussion, which would indicate pulp necrosis.
• Teeth presenting external or internal resorption, with adverse pulpal reactions which may affect the outcome of the study.
• Teeth with cervical caries; which can't be evaluated on periapical radiographs

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Egypt

Location

MeSH Terms

Interventions

EverX Posterior; Composite Resins

Intervention Hierarchy (Ancestors)

Resins, Synthetic; Plastics; Polymers; Macromolecular Substances; Dental Materials; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Olfat Hassanein, Professor

  Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• 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

Study Record Dates

• First Submitted: July 10, 2019
• First Posted: July 15, 2019
• Study Start: September 1, 2020
• Primary Completion: September 1, 2021
• Study Completion: September 30, 2021
• Last Updated: November 9, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)