Clinical Performance of Fiber-Reinforced Dentin Replacement Materials

NCT ID: NCT07320885

Last Updated: 2026-01-06

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

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-01

Study Completion Date

2024-08-15

Brief Summary

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the current study was conducted to evaluate and compare the flowable short fiber-reinforced (SFRC) and flowable bulk-fill resin composites (BFCs) regarding their 4-year clinical performance as dentin replacement materials in class II cavities.

Detailed Description

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the current study was conducted to evaluate and compare the flowable short fiber-reinforced (SFRC) and flowable bulk-fill resin composites (BFCs) regarding their 4-year clinical performance as dentin replacement materials in class II cavities. Forty patients were enrolled in the study. Each patient received three class II cavities; one of them was restored with flowable SFRC for dentin replacement, while in the other two cavities, dentin was replaced with two different flowable BFCs. The three dentin replacements were veneered with one particulate filler resin composite (PFC) (Essentia, GC). World Dental Federation (FDI) criteria were used for clinical assessment of the restorations at 1-week (baseline), 6, 12, 18-months, 2, 3, and 4-year intervals.

Conditions

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Caries; Dentin Caries Class II

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Ever x flow short-fiber reinforced composite

Ever x flow was used as dentin replacement material in class II cavities

Group Type EXPERIMENTAL

Ever x flow

Intervention Type OTHER

Ever x flow was used as dentin replacement material

SDR flowable bulk-fill resin composite

SDR was used as dentin replacement material

Group Type EXPERIMENTAL

SDR

Intervention Type OTHER

SDR was used as dentin replacement material in class II cavities

Tetric N-Flow Bulk fill resin composite

Tetric N-Flow Bulk fill was used as dentin replacement material

Group Type EXPERIMENTAL

Tetric N-Flow Bulk fill

Intervention Type OTHER

Tetric N-Flow Bulk fill was used as dentin replacement material in class II cavities

Interventions

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Ever x flow

Ever x flow was used as dentin replacement material

Intervention Type OTHER

SDR

SDR was used as dentin replacement material in class II cavities

Intervention Type OTHER

Tetric N-Flow Bulk fill

Tetric N-Flow Bulk fill was used as dentin replacement material in class II cavities

Intervention Type OTHER

Other Intervention Names

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flowable FRC

Eligibility Criteria

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Inclusion Criteria

* having good oral hygiene.
* having at least 3 posterior teeth with moderate to large primary proximal carious lesions (score 4 or 5 ICDAS).
* ranging in age from 20 to 40 years.
* with normal occlusion.
* accepting to participate in the study by signing an Arabic-written consent according to the regulations of the Mansoura University Ethical Committee.

Exclusion Criteria

* bad oral hygiene.
* severe chronic periodontitis.
* having installed orthodontic appliances.
* abnormal occlusion.
* parafunctional habits or allergic reaction to any of the materials used in the study.
* teeth with irreversible pulpitis or non-vital teeth.
* fractured or cracked teeth. previously restored teeth.
* teeth with deep sub-gingival cavity margins.
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Youness Saleh

lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Mansoura University

Al Mansurah, Dakahlia Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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A11120520

Identifier Type: -

Identifier Source: org_study_id

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