NCT07849426

Brief Summary

The goal of this clinical trial is to learn if ion releasing composite materials works to induce remineralization of caries affected dentin in adults. This study was designed to test the null hypothesis that there were no significant differences in the two-year clinical performance of ion-releasing and non ion-releasing composite restorative systems in class V carious lesions. Participants recieved four restorative materials Visit the clinic once every 6 months for follow up

Trial Health

75
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
7mo left

Started May 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress71%
May 2025May 2027

Study Start

First participant enrolled

May 10, 2025

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 20, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 30, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

September 30, 2026

Status Verified

May 1, 2026

Enrollment Period

2 years

First QC Date

September 20, 2026

Last Update Submit

September 24, 2026

Conditions

Class V Dental Caries

Keywords

Class V carious lesions, ion releasing materials

Outcome Measures

Primary Outcomes (1)

  • Clinical evaluation scores of Class V restorations according to the revised 2023 FDI criteria

    1\. FDI criteria score-Functional (F1 ; F2 ; F4 ; F5 ), biological (B1; B2 ; B3) aesthetic properties ( A2 ; A3), According to the revised 2023 FDI criteria for, 1. Aesthetic properties Restorations will be evaluated for A2 (marginal staining), and A3 (color match). 2. Functional properties Restorations will be evaluated for F1 (fracture/retention) and F2 (marginal adaptation) F4 (Form and contour); F5 (Occlusion and wear (Abfraction)). 3. Biological properties Restoration assessment of B1 (caries at restoration margin) B2 (Tooth defects at restoration margin); B3 (Postoperative hyper-sensitivity) according to the revised 2023 FDI criteria. Mean (SD) scores and the proportion of clinically acceptable restorations (scores 1-3) versus unacceptable restorations (scores 4-5) will be reported. Lower scores indicate better clinical performance. Unit of Measure: FDI

    Time Frame: Post-restoration baseline (1 weeks), 6, 12, and 24 months

Secondary Outcomes (1)

  • Clinical evaluation scores of Class V restorations according to the revised 2023 FDI criteria

    Time Frame: Post-restoration baseline (1 weeks), 6, 12, and 24 months

Study Arms (4)

Group 1, ion releasing resin composite

EXPERIMENTAL

test arm

Device: Ion-releasing resin composite

Group 2, Giomer based composite

EXPERIMENTAL

test arm

Device: Giomer based composite

Group 3, non-ion-releasing ormocer based composite

EXPERIMENTAL

test arm

Device: Non-ion-releasing ormocer based composite

Group 4, non-ion-releasing flowable resin composite

EXPERIMENTAL

test arm

Device: Non-ion-releasing resin-based composite

Interventions

Giomer based compositeDEVICE

Carious Class V cavity preparation and restoration according to manufacturer instructions

Group 2, Giomer based composite
Non-ion-releasing ormocer based compositeDEVICE

Carious Class V cavity preparation and restoration according to manufacturer instructions

Group 3, non-ion-releasing ormocer based composite
Non-ion-releasing resin-based compositeDEVICE

Carious Class V cavity preparation and restoration according to manufacturer instructions

Group 4, non-ion-releasing flowable resin composite
Ion-releasing resin compositeDEVICE

Carious Class V cavity preparation and restoration according to manufacturer instructions

Group 1, ion releasing resin composite

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Male or female gender.
  • Only cooperative patients are approved to participate in the trial
  • Medically free adult patients.
  • The age range of the patients is 20- 40 years who have at least four no symptomatic buccal Class V carious lesions.
  • Patients with normal occluusion

You may not qualify if:

  • Allergic history concerning methacrylates
  • Pregnancy.
  • Heavy smoking; xerostomia.
  • Lack of compliance.
  • Patients with disabilities.
  • Patients who have systemic diseases or severe medically compromised patients.
  • Patients with severe bruxism, clenching, or temporomandibular joint disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry

Al Mansurah, Egypt

Location

Related Publications (1)

  • Ismail HS, Soliman HAN, Ali AI, Raghip AG, Albelasy EH. A two-year randomized clinical trial of bulk-fill and ion-releasing composites with universal adhesives in class V carious lesions. Clin Oral Investig. 2026 Apr 11;30(5):172. doi: 10.1007/s00784-026-06852-5.

    PMID: 41964796RESULT

Related Links

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2026

First Posted

September 30, 2026

Study Start

May 10, 2025

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

September 30, 2026

Record last verified: 2026-05

Locations

EG(1)