NCT07496047

Brief Summary

To clinically evaluate the performance of preheated versus non-preheated short fiber-reinforced composite (SFRC) restorations in Class I posterior cavities over a 12-month period

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2025

Geographic Reach
1 country

2 active sites

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

Study Start

First participant enrolled

March 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 17, 2026

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2026

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

March 22, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 27, 2026

Completed
Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

1 year

First QC Date

March 22, 2026

Last Update Submit

March 22, 2026

Conditions

Composite ResinsTeeth SensitivityRestoration DesignComposite Restoration

Keywords

Short fiber-reinforced compositepreheatingClass I cavitiesFDI criteriarandomized clinical trial

Outcome Measures

Primary Outcomes (1)

  • Marginal adaptation

    Assessment of the marginal integrity of restorations using FDI criteria, including presence of gaps, discoloration, or ditching at restoration margins.

    Baseline, 6 months, 9 months, and 12 months

Secondary Outcomes (3)

  • Restoration retention and fracture resistance

    Baseline, 6 months, 9 months, and 12 months

  • Postoperative sensitivity

    Baseline, 6 months, 9 months, and 12 months

  • Recurrence of caries

    Baseline, 6 months, 9 months, and 12 months

Study Arms (2)

Preheated Short Fiber-Reinforced Composite (SFRC) Restorations

EXPERIMENTAL
Other: Preheated everX Posterior composite

Non-Preheated Short Fiber-Reinforced Composite (SFRC) Restorations

EXPERIMENTAL
Other: Non-preheated everX Posterior composite

Interventions

Preheated everX Posterior compositeOTHER

Application of everX Posterior composite after preheating to 54°C using a composite warmer, followed by placement, adaptation, and curing according to manufacturer guidelines.

Preheated Short Fiber-Reinforced Composite (SFRC) Restorations
Non-preheated everX Posterior compositeOTHER

Application of everX Posterior composite at room temperature, placed and cured according to manufacturer instructions.

Non-Preheated Short Fiber-Reinforced Composite (SFRC) Restorations

Eligibility Criteria

Age25 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Presence of bilateral Class I carious lesions in posterior teeth requiring restorative treatment
  • Teeth with vital pulps and no signs of irreversible pulpitis
  • Good general health

You may not qualify if:

  • Patients with poor oral hygiene or high caries risk
  • Presence of parafunctional habits (e.g., bruxism)
  • Patients with systemic diseases affecting oral health or salivary flow

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Restorative Department, Faculty of Dentistry, Tanta University

Tanta, Tanta, 31527, Egypt

Location

Restorative Department, Faculty of Dentistry, Tanta University

Tanta, Tanta, Egypt

Location

Related Publications (5)

  • Hartanto C, Farahanny W, Dennis D. Comparative Evaluation of Short Fiber-reinforced Composite Resin Thickness on Fracture Resistance of Class II Composite Restoration: An In Vitro Study. J Contemp Dent Pract. 2020 Nov 1;21(11):1201-1204.

    PMID: 33850063RESULT

  • Alshabib A, Jurado CA, Tsujimoto A. Short fiber-reinforced resin-based composites (SFRCs); Current status and future perspectives. Dent Mater J. 2022 Oct 2;41(5):647-654. doi: 10.4012/dmj.2022-080. Epub 2022 Jul 20.

    PMID: 35858793RESULT

  • 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: 39881262RESULT

  • Sen Yavuz B, Kaya R, Kodaman Dokumacigil N, Ozgur EG, Bekiroglu N, Kargul B. Clinical performance of short fiber reinforced composite and glass hybrid on hypomineralized molars: A 36-month randomized split-mouth study. J Dent. 2024 May;144:104919. doi: 10.1016/j.jdent.2024.104919. Epub 2024 Mar 1.

    PMID: 38431187RESULT

  • Hamdi K, Elsebaai A, Harp YS, Hamama HH. Clinical performance of short fiber-reinforced composite resin restoration in large posterior cavities: a systematic review and meta-analysis. Sci Rep. 2025 Dec 22;15(1):44334. doi: 10.1038/s41598-025-31441-z.

    PMID: 41429866RESULT

MeSH Terms

Conditions

Dentin Sensitivity

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

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
Principal Investigator

Study Record Dates

First Submitted

March 22, 2026

First Posted

March 27, 2026

Study Start

March 1, 2025

Primary Completion

March 17, 2026

Study Completion

March 20, 2026

Last Updated

March 27, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

EG(2)