NCT07688343

Brief Summary

Different ion-releasing restorative systems will be applied in class II cavities then their clinical performance will be evaluated and compared

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
11mo left

Started Jun 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 Progress56%
Jun 2025Jul 2027

Study Start

First participant enrolled

June 1, 2025

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 30, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 7, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

July 9, 2026

Status Verified

May 1, 2026

Enrollment Period

2 years

First QC Date

June 30, 2026

Last Update Submit

July 7, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • difference between baseline and after two years of evaluation

    Changes in restoration performance according to the modified Federation Dentaire Internationale (FDI) criteria from baseline to 2 years. Scores range from 1 to 5, where lower scores indicate better clinical performance and higher scores indicate poorer clinical performance.

    baseline to two-years

Study Arms (4)

conventional bulk fill restorative system

EXPERIMENTAL

posterior cavities restored with conventional bulk fill restorative system applied in single increment according to the manufacturer's instructions

Procedure: conventional bulk fill restorative system

ion- releasing restorative system 1

EXPERIMENTAL

posterior cavities restored with ion-releasing restorative system applied 1 in single increment according to the manufacturer's instructions

Procedure: ion-releasing restorative system 1

ion-releasing restorative system 2

EXPERIMENTAL

posterior cavities restored with ion-releasing restorative system 2 applied in single increment according to the manufacturer's instructions

Procedure: ion-releasing restorative system 2

ion-releasing restorative system 3

EXPERIMENTAL

posterior cavities restored with ion-releasing restorative system 3 applied in single increment according to the manufacturer's instructions

Procedure: ion-releasing restorative system 3

Interventions

conventional bulk fill restorative system used for posterior applications

conventional bulk fill restorative system

ion-releasing restorative system 1 used for posterior applications

ion- releasing restorative system 1

ion-releasing restorative system 2 used for posterior applications

ion-releasing restorative system 2

ion-releasing restorative system 3 used for posterior applications

ion-releasing restorative system 3

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • at least 4 carious posterior teeth

You may not qualify if:

  • pregnancy - not able to attend for regular follow-up -smokers or very bad oral hygiene

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Mansoura University

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Officials

  • Asmaa A Elbanna, Assistant Lecturer

    Faculty of Dentistry, Mansoura University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 30, 2026

First Posted

July 7, 2026

Study Start

June 1, 2025

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

July 9, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

study protocol and statistical analysis will be shared to other researchers

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Data will be available after two years
Access Criteria
anyone

Locations