Class V Dental CariesNCT07849426

Two Year Clinical Performance of Ion-releasing and Non Ion-releasing Composite Restorative Systems in Restoring Cervical Carious Lesions.

A study testing Ion-releasing resin composite, Giomer based composite and Non-ion-releasing ormocer based composite in people with Class V Dental Caries, run by Mansoura University at 1 site in Egypt.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 20 to 40 years
Conditions the study is for: Class V Dental Caries
What is being tested?: Ion-releasing resin composite, Giomer based composite and Non-ion-releasing ormocer based composite
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteEgypt
Study dates: 10 May 2025to May 2027
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 40 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

Faculty of Dentistry
Al Mansurah

Other trials in Egypt

About this study

Official title: Ion-Releasing Versus Non Ion-Releasing Composite Restorative Systems: Two-Year Clinical Performance in Carious Cervical Lesions and In-Vitro Investigations

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

Conditions: Class V Dental Caries
Being tested: Ion-releasing resin composite, Giomer based composite, Non-ion-releasing ormocer based composite, Non-ion-releasing resin-based composite
Keywords: Class V carious lesions, ion releasing materials

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ion-releasing resin compositeDevice
Carious Class V cavity preparation and restoration according to manufacturer instructions
Giomer based compositeDevice
Carious Class V cavity preparation and restoration according to manufacturer instructions
Non-ion-releasing ormocer based compositeDevice
Carious Class V cavity preparation and restoration according to manufacturer instructions
Non-ion-releasing resin-based compositeDevice
Carious Class V cavity preparation and restoration according to manufacturer instructions

Study groups in NCT07849426
Study group	Role	What they receive
Group 1, ion releasing resin composite	Experimental	test arm Receives: Device: Ion-releasing resin composite
Group 2, Giomer based composite	Experimental	test arm Receives: Device: Giomer based composite
Group 3, non-ion-releasing ormocer based composite	Experimental	test arm Receives: Device: Non-ion-releasing ormocer based composite
Group 4, non-ion-releasing flowable resin composite	Experimental	test arm Receives: Device: Non-ion-releasing resin-based composite

What is being measured

The primary outcome is the main question the study is designed to answer.

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,
2. Aesthetic properties Restorations will be evaluated for A2 (marginal staining), and A3 (color match).
3. Functional properties Restorations will be evaluated for F1 (fracture/retention) and F2 (marginal adaptation) F4 (Form and contour); F5 (Occlusion and wear (Abfraction)).
4. 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
Measured: 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
1. FDI criteria score- Aesthetic properties: (A1) Surface luster and surface texture, Miscellaneous properties: (M1) Patient's view According to the revised 2023 FDI criteria for,
2. Aesthetic properties: (A1) Surface luster and surface texture
3. Miscellaneous properties: (M1) Patient's view 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
Measured: Time Frame: Post-restoration baseline (1 weeks), 6, 12, and 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 May 2025May 2027

First posted30 Sep 2026
Study start10 May 2025
Primary completionMay 2027 (estimated)
Study completionMay 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Class V Dental CariesStudies of the same condition, open and under way.
More trials run by Mansoura UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07849426
Sponsor's protocol ID: MDP.25.03.1.
Status last verified: May 2026
First submitted: 20 Sep 2026
Last updated: 30 Sep 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes

Publications

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.
PubMed 41964796

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Zirconia-Reinforced Glass Ionomer Versus Injectable Giomer in Class V Restorations
Class V Dental Caries, Type 2 Diabetes Mellitus, Giomer Technology; Injectable Resin Composite; Zirconia-Modified Glass Ionomer
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Self-Cure vs. Highly Filled Flowable Composite in Carious Cervical Lesions: 18-Month RCT
Carious Cervical Lesions
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Clinical Performance of Giomer-Based Composite Restorations in Class V Carious Lesions in Diabetic and Non-Diabetic Patients
Diabetes Mellitus
Active, not recruiting
Comparative Evaluation of Class V Restorations
Secondary Caries, Dental Restoration Failure of Marginal Integrity
Not yet recruiting
18-Month Clinical Evaluation of Self-Adhesive Flowable Giomer Compared to Conventional Flowable Giomer in Carious Cervical Lesions: A Randomized Clinical Trial
Cervical Caries

All Class V Dental Caries trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Ion-Releasing Versus Non Ion-Releasing Composite Restorative Systems: Two-Year Clinical Performance in Carious Cervical Lesions and In-Vitro Investigations
ClinicalTrials.gov ID: NCT07849426
Acronym / sponsor ID: MDP.25.03.1.
Conditions: Class V Dental Caries
Keywords: Class V carious lesions, ion releasing materials
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 40 participants (actual)
Lead sponsor: Mansoura UniversityUniversity, hospital or other
Study start: 10 May 2025 (actual)
Primary completion: May 2027 (estimated)
Study completion: May 2027 (estimated)
First posted: 30 Sep 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The goal of this clinical trial is to learn if ion releasing composite materials works to induce remineralization of caries affected dentin in adults.

Participants recieved four restorative materials Visit the clinic once every 6 months for follow up

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Group 1, ion releasing resin composite	Experimental	Device: Ion-releasing resin compositetest arm
Group 2, Giomer based composite	Experimental	Device: Giomer based compositetest arm
Group 3, non-ion-releasing ormocer based composite	Experimental	Device: Non-ion-releasing ormocer based compositetest arm
Group 4, non-ion-releasing flowable resin composite	Experimental	Device: Non-ion-releasing resin-based compositetest arm

Who may qualify

Ages: 20 to 40 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (7 listed)

Allergic history concerning methacrylates
Pregnancy.
Heavy smoking; xerostomia.
Lack of compliance.
Patients with disabilities.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Ion-releasing resin compositeCarious Class V cavity preparation and restoration according to manufacturer instructions	Device	Group 1, ion releasing resin composite
Giomer based compositeCarious Class V cavity preparation and restoration according to manufacturer instructions	Device	Group 2, Giomer based composite
Non-ion-releasing ormocer based compositeCarious Class V cavity preparation and restoration according to manufacturer instructions	Device	Group 3, non-ion-releasing ormocer based composite
Non-ion-releasing resin-based compositeCarious Class V cavity preparation and restoration according to manufacturer instructions	Device	Group 4, non-ion-releasing flowable resin composite

Primary outcome

Clinical evaluation scores of Class V restorations according to the revised 2023 FDI criteria
Time frame: Time Frame: Post-restoration baseline (1 weeks), 6, 12, and 24 months
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

1 secondary outcome

Clinical evaluation scores of Class V restorations according to the revised 2023 FDI criteria
Time frame: Time Frame: Post-restoration baseline (1 weeks), 6, 12, and 24 months

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
Results publication: PubMed 41964796Ismail 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.
Related InfoLink provided by the sponsor.

Related trials for Class V Dental Caries

Not yet recruiting
Zirconia-Reinforced Glass Ionomer Versus Injectable Giomer in Class V Restorations
Class V Dental Caries, Type 2 Diabetes Mellitus, Giomer Technology; Injectable Resin Composite; Zirconia-Modified Glass Ionomer
Not yet recruiting
Self-Cure vs. Highly Filled Flowable Composite in Carious Cervical Lesions: 18-Month RCT
Carious Cervical Lesions
Not yet recruiting
Clinical Performance of Giomer-Based Composite Restorations in Class V Carious Lesions in Diabetic and Non-Diabetic Patients
Diabetes Mellitus
Active, not recruiting
Comparative Evaluation of Class V Restorations
Secondary Caries, Dental Restoration Failure of Marginal Integrity
Not yet recruiting
18-Month Clinical Evaluation of Self-Adhesive Flowable Giomer Compared to Conventional Flowable Giomer in Carious Cervical Lesions: A Randomized Clinical Trial
Cervical Caries

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical evaluation scores of Class V restorations according to the revised 2023 FDI criteria (time frame: Time Frame: Post-restoration baseline (1 weeks), 6, 12, and 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07849426, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.