Secondary CariesNCT06164418
Comparative Evaluation of Class V Restorations
A study testing Dental restoration in people with Secondary Caries and Dental Restoration Failure of Marginal Integrity, run by Mansoura University at 1 site in Egypt.
Trial summary
To evaluate and compare the 2-year clinical performance of Class V restorations using various restorative systems with ion-releasing and non-ion-releasing composites, utilizing fluoride-free and fluoride-releasing universal adhesives for bonding Read more about this study
- Who is it for?
- Ages 35 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Secondary Caries, Dental Restoration Failure of Marginal Integrity
- What is being tested?
- Dental restoration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Dec 2023to 15 Dec 2025
- 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 35 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with one primary cervical caries on the buccal surface of any of their upper or lower posterior teeth. The cervical lesions must have an enamel margin occlusally and a cervical dentin margin
- Patients must have a good oral hygiene;
- Patients with tooth gives a positive response to testing with an electric pulp tester
- Patients with normal and full occlusion,
- Patients with opposing teeth should be natural with no restorations.
Who cannot join
- High caries risk patients with extremely poor oral hygiene,
- Patients involved in orthodontic treatment or periodontal surgery,
- Patients with periodontally involved teeth (chronic periodontitis)
- Patients with heavy bruxism habits and clenching
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Evaluation of Class V Restorations: 2-Year Randomized Double-Blind Trial Comparing Ion-Releasing Materials and Resin Composite
To evaluate and compare the 2-year clinical performance of Class V restorations using various restorative systems with ion-releasing and non-ion-releasing composites, utilizing fluoride-free and fluoride-releasing universal adhesives for bonding
Read the detailed description
The experimental design description adhered to the guidelines provided by the Consolidated Standards of Reporting Trials (CONSORT) statement. The present study is planned as a double-blinded randomized clinical trial, ensuring that both the patients and the examiner are unaware of the treatment allocation. The trial will follow a parallel design. A total of one hundred adult patients, who are seeking dental treatment, will be enrolled in the study. The participants will be recruited from the Operative Department clinic at the Faculty of Dentistry, University of Mansoura. The study will focus on one hundred Class V restorations.
No active advertisement will be used for participant recruitment, and instead, a convenience sample will be formed. Prior to participating in the study, each patient will be required to provide informed consent by signing a consent form. The study is scheduled to be conducted from November 2023 to November 2025. The form and protocol of the study will be approved by Mansoura University's ethics committee before initiation.
To determine the appropriate sample size, previous studies examining the clinical success rate of posterior class V restorations restored with ion-releasing materials were considered. These studies reported a 100% success rate at a two-year follow-up. Based on various parameters, including a significance level of 5%, a test power of 80%, and an equivalence limit of 15%, the sample size was calculated. Considering a potential dropout rate of 20%, a sample size of 100 subjects was determined to be suitable.
- Being tested
- Dental restoration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental restorationProcedure or surgery
Each patient will receive a cervical restoration using the corresponding group adhesive and restorative material
| Study group | Role | What they receive |
|---|---|---|
| a nanohybrid resin composite material with a universal adhesive | Placebo comparator | Each patient will randomly receive one cervical restoration with one of the tested restorative systems Receives: Procedure: Dental restoration |
| a nanohybrid resin composite material with a fluoride-releasing universal adhesive | Active comparator | Each patient will randomly receive one cervical restoration with one of the tested restorative systems Receives: Procedure: Dental restoration |
| ion-releasing restorative material with a universal adhesive | Placebo comparator | Each patient will randomly receive one cervical restoration with one of the tested restorative systems Receives: Procedure: Dental restoration |
| ion-releasing restorative material with a fluoride-releasing universal adhesive | Active comparator | Each patient will randomly receive one cervical restoration with one of the tested restorative systems Receives: Procedure: Dental restoration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of aesthetic, functional and biological properties for each group
Percentage of aesthetic, functional and biological properties that will be clinically assessed using World Dental Federation parameters for each restorative system group
Measured: 2 years after restoration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study start2 Dec 2023
- Primary completion2 Dec 2025 (estimated)
- Study completion15 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Secondary CariesStudies of the same condition, open and under way.
- 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
- Parallel groups
- Model description
- Each patient will receive one restoration in a posterior tooth on any side randomly selected from the 4 tested restorative systems groups, all materials will be used according to manufacturers' instructions
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hoda saleh, Mansoura University
- Investigators
- Hoda S Ismail, Lecturer, Principal investigator, Faculty of Dentistry, Mansoura University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06164418
- Sponsor's protocol ID
- A01011023 CD
- Status last verified
- Jun 2025
- First submitted
- 2 Dec 2023
- Last updated
- 3 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Class V Restorations: 2-Year Randomized Double-Blind Trial Comparing Ion-Releasing Materials and Resin Composite
- ClinicalTrials.gov ID
- NCT06164418
- Acronym / sponsor ID
- A01011023 CD
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 2 Dec 2023 (actual)
- Primary completion
- 2 Dec 2025 (estimated)
- Study completion
- 15 Dec 2025 (estimated)
- First posted
- 11 Dec 2023 (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.
To evaluate and compare the 2-year clinical performance of Class V restorations using various restorative systems with ion-releasing and non-ion-releasing composites, utilizing fluoride-free and fluoride-releasing universal adhesives for bonding
Detailed description
The experimental design description adhered to the guidelines provided by the Consolidated Standards of Reporting Trials (CONSORT) statement. The present study is planned as a double-blinded randomized clinical trial, ensuring that both the patients and the examiner are unaware of the treatment allocation. The trial will follow a parallel design. A total of one hundred adult patients, who are seeking dental treatment, will be enrolled in the study. The participants will be recruited from the Operative Department clinic at the Faculty of Dentistry, University of Mansoura. The study will focus on one hundred Class V restorations.
No active advertisement will be used for participant recruitment, and instead, a convenience sample will be formed. Prior to participating in the study, each patient will be required to provide informed consent by signing a consent form. The study is scheduled to be conducted from November 2023 to November 2025. The form and protocol of the study will be approved by Mansoura University's ethics committee before initiation.
To determine the appropriate sample size, previous studies examining the clinical success rate of posterior class V restorations restored with ion-releasing materials were considered. These studies reported a 100% success rate at a two-year follow-up. Based on various parameters, including a significance level of 5%, a test power of 80%, and an equivalence limit of 15%, the sample size was calculated. Considering a potential dropout rate of 20%, a sample size of 100 subjects was determined to be suitable.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Each patient will receive one restoration in a posterior tooth on any side randomly selected from the 4 tested restorative systems groups, all materials will be used according to manufacturers' instructions
| Arm | Type | Receives |
|---|---|---|
| a nanohybrid resin composite material with a universal adhesive | Placebo comparator | Procedure: Dental restorationEach patient will randomly receive one cervical restoration with one of the tested restorative systems |
| a nanohybrid resin composite material with a fluoride-releasing universal adhesive | Active comparator | Procedure: Dental restorationEach patient will randomly receive one cervical restoration with one of the tested restorative systems |
| ion-releasing restorative material with a universal adhesive | Placebo comparator | Procedure: Dental restorationEach patient will randomly receive one cervical restoration with one of the tested restorative systems |
| ion-releasing restorative material with a fluoride-releasing universal adhesive | Active comparator | Procedure: Dental restorationEach patient will randomly receive one cervical restoration with one of the tested restorative systems |
Who may qualify
- Ages
- 35 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients with one primary cervical caries on the buccal surface of any of their upper or lower posterior teeth. The cervical lesions must have an enamel margin occlusally and a cervical dentin margin
- Patients must have a good oral hygiene;
- Patients with tooth gives a positive response to testing with an electric pulp tester
- Patients with normal and full occlusion,
- Patients with opposing teeth should be natural with no restorations.
Key exclusion criteria (4 listed)
- High caries risk patients with extremely poor oral hygiene,
- Patients involved in orthodontic treatment or periodontal surgery,
- Patients with periodontally involved teeth (chronic periodontitis)
- Patients with heavy bruxism habits and clenching
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 |
|---|---|---|
| Dental restorationEach patient will receive a cervical restoration using the corresponding group adhesive and restorative material | Procedure or surgery | a nanohybrid resin composite material with a fluoride-releasing universal adhesive, a nanohybrid resin composite material with a universal adhesive, ion-releasing restorative material with a fluoride-releasing universal adhesive, ion-releasing restorative material with a universal adhesive |
Primary outcome
Percentage of aesthetic, functional and biological properties for each group
Time frame: 2 years after restoration
Percentage of aesthetic, functional and biological properties that will be clinically assessed using World Dental Federation parameters for each restorative system group
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 3 Jun 2025.
- Individual participant dataSharing planned: Yes
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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.
Hoda S Ismail, Lecturer principal investigator
Faculty of Dentistry, Mansoura University, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dental restoration in people with Secondary Caries and Dental Restoration Failure of Marginal Integrity, run by Mansoura University at 1 site in Egypt.
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 4 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 3 Jun 2025. 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. Some participants in this study may receive a placebo. 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?
Percentage of aesthetic, functional and biological properties for each group (time frame: 2 years after restoration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jun 2025.