NCT07849478

Brief Summary

The goal of this clinical trial is to learn if ion-releasing composite works to induce remineralization in caries-affected dentin in adults. This study was designed to test the null hypothesis that there was no significant differences in: The two-year clinical performance of ion-releasing and conventional bulk-fill resin composite restorative systems. Participants:

  • received three different restorative systems
  • Visit the clinic once every 6 months for checkups and tests

Trial Health

75
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress70%
May 2025May 2027

Study Start

First participant enrolled

May 29, 2025

Completed
1.3 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

1.9 years

First QC Date

September 20, 2026

Last Update Submit

September 24, 2026

Conditions

Class I Dental Caries

Keywords

ion-releasing, dentin remineralization, class I

Outcome Measures

Primary Outcomes (1)

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

    FDI criteria score-Functional (F1 Fracture/Retention; F2 marginal adaptation; F5 Occlusion and wear), biological (B1 caries at restoration margin; B2 dental hard tissue defects at restoration margin; B3 Postoperative hyper-sensitivity), Aesthetic properties (A2 Marginal staining), According to the revised 2023 FDI criteria for, 1. Functional properties Restorations will be evaluated for F1 (fracture/retention), F2 (marginal adaptation), and F5 (Occlusion and wear) 2. Biological properties Restoration assessment of B1 (caries at restoration margin), B2 (dental hard tissue defects at restoration margin), and B3 Postoperative hyper-sensitivity) 3. Aesthetic properties Restorations will be evaluated for A2 (marginal staining) * 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 score

    one week, 6, 12, and 24 months

Secondary Outcomes (1)

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

    one week, 6, 12, and 24 months

Study Arms (3)

Group 1: self-cure ion-releasing bulk-fill resin composite

EXPERIMENTAL

Test arm

Device: self-cure ion-releasing bulk-fill resin composite

Group 2: ion-releasing bulk-fill resin composite

EXPERIMENTAL

Test arm

Device: ion-releasing bulk-fill resin composite

Group 3: conventional bulk-fill resin composite

EXPERIMENTAL

Control arm

Device: conventional bulk-fill resin composite

Interventions

self-cure ion-releasing bulk-fill resin compositeDEVICE

class I cavity preparation and restoration with self-cure ion-releasing bulk-fill resin composite

Group 1: self-cure ion-releasing bulk-fill resin composite
ion-releasing bulk-fill resin compositeDEVICE

class I cavity preparation and restoration with ion-releasing bulk-fill resin composite

Group 2: ion-releasing bulk-fill resin composite
conventional bulk-fill resin compositeDEVICE

class I cavity preparation and restoration with conventional bulk-fill resin composite

Group 3: conventional bulk-fill 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 three Class I 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- Mansoura University

Al Mansurah, Egypt

Location

Related Publications (1)

  • Raghip AGM, Comisi JC, Hamama HH, Mahmoud SH. Two-year randomized clinical trial to evaluate the performance of posterior bulk-fill resin composite with ionic releasing restorative material. J Dent. 2025 Sep;160:105912. doi: 10.1016/j.jdent.2025.105912. Epub 2025 Jun 13.

    PMID: 40518039BACKGROUND

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 29, 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)