NCT05380973

Brief Summary

This study is conducted to evaluate the clinical performance of two fiber-reinforced resin composite restorations compared to nanohybrid resin composite restorations in patients with posterior MOD cavities

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 14, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 19, 2022

Completed
11 months until next milestone

Study Start

First participant enrolled

April 10, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2024

Completed
Last Updated

November 26, 2024

Status Verified

November 1, 2024

Enrollment Period

1.5 years

First QC Date

May 14, 2022

Last Update Submit

November 22, 2024

Conditions

Dental Restoration Failure

Keywords

polyethylene fiber reinforced resin compositeglass fiber reinforced resin compositenanohybrid resin composite

Outcome Measures

Primary Outcomes (1)

  • Change in the clinical performance

    Measured using modified USPHS criteria for clinical evaluation of restoration failure.

    Change from the baseline at 12 months.

Study Arms (2)

fiber reinforced resin composite

EXPERIMENTAL

Short fiber resin composite (SFRC) (Ever X Posterior, GC, Japan) The material will be applied according to manufacturer instructions. A thin layer of flowable resin composite will be applied prior placing the short fiber reinforced composite, then SFRC (Ever X Posterior, GC, Tokyo, Japan) will be injected in bulk, and light cured for 20 seconds, nanohybrid resin composite will be placed to the rest of the cavity incrementally. Polyethylene ribbon fiber (Ribbond Inc., Seattle, WA, USA) The material will be applied according to manufacturer instructions. After application of a thin layer of the flowable resin composite to the cavity, a layer of Polyethylene ribbon fiber on the unpolymerized flowable composite will be condensed with a plugger and polymerized for 20 seconds then, nanohybrid resin composite will be placed to the rest of the cavity incrementally.

Other: Short fiber resin compositeOther: Polyethylene ribbon fiber

Nanohybrid resin composite

ACTIVE COMPARATOR

A thin layer of flowable composite will be applied then nanohybrid resin composite will be applied to the rest of the cavity using the conventional incremental technique according to manufacturer instructions.

Other: Short fiber resin compositeOther: Polyethylene ribbon fiber

Interventions

Short fiber resin compositeOTHER

resin composite reinforced with short glass fibers

Also known as: (Ever X Posterior, GC, Japan)
Nanohybrid resin compositefiber reinforced resin composite
Polyethylene ribbon fiberOTHER

resin composite reinforced with polyethylene ribbon fiber

Also known as: (Ribbond Inc., Seattle, WA, USA)
Nanohybrid resin compositefiber reinforced resin composite

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • MOD carious lesions premolars and molars.
  • Vital upper or lower teeth with no signs of irreversible pulpitis.
  • Presence of favorable occlusion and teeth are in normal contact with the adjacent teeth.

You may not qualify if:

  • Deep carious defects (close to pulp, less than 1 mm distance).
  • Periapical pathology or signs of pulpal pathology.
  • Endodontically treated teeth.
  • Tooth hypersensitivity.
  • Possible prosthodontic restoration of teeth.
  • Heavy occlusion and occlusal contacts or history of bruxism
  • Severe periodontal affection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

faculty of dentistry-Cairo university

Cairo, Egypt

Location

Related Publications (1)

  • Mohamed MH, Abouauf EA, Mosallam RS. Clinical performance of class II MOD fiber reinforced resin composite restorations: an 18-month randomized controlled clinical trial. BMC Oral Health. 2025 Jan 30;25(1):159. doi: 10.1186/s12903-025-05521-5.

    PMID: 39881262DERIVED

Study Officials

  • Rania Sayed Mosallam

    Professor

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
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, conservative department

Study Record Dates

First Submitted

May 14, 2022

First Posted

May 19, 2022

Study Start

April 10, 2023

Primary Completion

October 10, 2024

Study Completion

October 10, 2024

Last Updated

November 26, 2024

Record last verified: 2024-11

Locations

EG(1)