Secondary Caries Dental Restoration Failure of Marginal IntegrityNCT06543680
Resin Modified Glass Ionomer Versus Self-Adhesive Resin Composite Restorative Systems
A study testing Dental restoration in people with Secondary Caries Dental Restoration Failure of Marginal Integrity, run by Mansoura University at 1 site in Egypt.
Trial summary
To evaluate and compare two-year clinical performance of commercially available resin modified glass ionomer cement, self-adhesive composite hybrid and self-adhesive flowable composite restorative materials for non-carious cervical lesions Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Secondary Caries Dental Restoration Failure of Marginal Integrity
- What is being tested?
- Dental restoration
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteEgypt
- Study dates
- 29 May 2023to 31 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Inclusion criteria will be fair oral hygiene patients with 30-60 years. Patients with at least three similarly sized non-carious cervical lesions (NCCLs) in vital teeth that need for restoration and depth of NCCLs will be 1-3 mm with at least 50% of margins without enamel.
Who cannot join
- Exclusion criteria will be patients with severe periodontitis, mobile teeth, fractures, severe bruxism, carious teeth, poor oral hygiene, teeth with irreversible pulpitis and endodontically treated teeth.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of dentistry mansoura university
Al Mansurah, Dakahliya, 35516
About this study
Official title: Resin Modified Glass Ionomer Versus Self-Adhesive Resin Composite Restorative Systems: Two Years Randomized Clinical Study in Class ᴠ
To evaluate and compare two-year clinical performance of commercially available resin modified glass ionomer cement, self-adhesive composite hybrid and self-adhesive flowable composite restorative materials for non-carious cervical lesions
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 35 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 105 Class V restorations.A randomized clinical trial will be performed. A number of 35 patients will be included in this study. Each patient will have at least three NCCLs. One of these lesions will be randomly restored with resin modified glass ionomer cement, the second lesion will be restored with self-adhesive Surefil One composite hybrid while the third lesion will be restored with self-adhesive flowable composite.
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 may 2023 to may 2025. The form and protocol of the study will be approved by Mansoura University's ethics committee before initiation.
Clinical evaluation for all restorations will be done at baseline (after insertion) and after 6, 12 and 24 months of clinical service by two calibrated independent examiners that will not share in restorations placement. It will be designed depending on modified USPHS criteria and FDI criteria
- Being tested
- Dental restoration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental restorationOther
Each patient will randomly receive one cervical restoration with one of the tested restorative systems
| Study group | Role | What they receive |
|---|---|---|
| Resin Modified Glass Ionomer cement | Active comparator | Each patient will randomly receive one cervical restoration with one of the tested restorative systems Receives: Other: Dental restoration |
| Self-Adhesive flowable composite | Placebo comparator | Each patient will randomly receive one cervical restoration with one of the tested restorative systems Receives: Other: Dental restoration |
| Self-Adhesive composite hybrid | Placebo comparator | Each patient will randomly receive one cervical restoration with one of the tested restorative systems Receives: Other: 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 and USPHS 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 posted9 Aug 2024
- Study start29 May 2023
- Primary completion29 May 2025 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Secondary Caries Dental Restoration Failure of Marginal IntegrityStudies 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
- Parallel groups
- Model description
- A randomized clinical trial will be performed. A number of 35 patients will be included in this study. Each patient will have at least three NCCLs. One of these lesions will be randomly restored with resin modified glass ionomer cement, the second lesion will be restored with self-adhesive Surefil One composite hybrid while the third lesion will be restored with self-adhesive flowable composite.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Elbahloul, Mansoura University
- Investigators
- Mohamed E Hamouda, Assistant Lecturer, Principal investigator, Faculty of Dentistry, Mansoura University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06543680
- Sponsor's protocol ID
- A0103023CD
- Status last verified
- Aug 2024
- First submitted
- 4 Aug 2024
- Last updated
- 9 Aug 2024
- 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 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resin Modified Glass Ionomer Versus Self-Adhesive Resin Composite Restorative Systems: Two Years Randomized Clinical Study in Class ᴠ
- ClinicalTrials.gov ID
- NCT06543680
- Acronym / sponsor ID
- A0103023CD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 29 May 2023 (actual)
- Primary completion
- 29 May 2025 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 9 Aug 2024 (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 two-year clinical performance of commercially available resin modified glass ionomer cement, self-adhesive composite hybrid and self-adhesive flowable composite restorative materials for non-carious cervical lesions
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 35 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 105 Class V restorations.A randomized clinical trial will be performed. A number of 35 patients will be included in this study. Each patient will have at least three NCCLs. One of these lesions will be randomly restored with resin modified glass ionomer cement, the second lesion will be restored with self-adhesive Surefil One composite hybrid while the third lesion will be restored with self-adhesive flowable composite.
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 may 2023 to may 2025. The form and protocol of the study will be approved by Mansoura University's ethics committee before initiation.
Clinical evaluation for all restorations will be done at baseline (after insertion) and after 6, 12 and 24 months of clinical service by two calibrated independent examiners that will not share in restorations placement. It will be designed depending on modified USPHS criteria and FDI criteria
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- A randomized clinical trial will be performed. A number of 35 patients will be included in this study. Each patient will have at least three NCCLs. One of these lesions will be randomly restored with resin modified glass ionomer cement, the second lesion will be restored with self-adhesive Surefil One composite hybrid while the third lesion will be restored with self-adhesive flowable composite.
| Arm | Type | Receives |
|---|---|---|
| Resin Modified Glass Ionomer cement | Active comparator | Other: Dental restorationEach patient will randomly receive one cervical restoration with one of the tested restorative systems |
| Self-Adhesive flowable composite | Placebo comparator | Other: Dental restorationEach patient will randomly receive one cervical restoration with one of the tested restorative systems |
| Self-Adhesive composite hybrid | Placebo comparator | Other: Dental restorationEach patient will randomly receive one cervical restoration with one of the tested restorative systems |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Inclusion criteria will be fair oral hygiene patients with 30-60 years. Patients with at least three similarly sized non-carious cervical lesions (NCCLs) in vital teeth that need for restoration and depth of NCCLs will be 1-3 mm with at least 50% of margins without enamel.
Key exclusion criteria (1 listed)
- Exclusion criteria will be patients with severe periodontitis, mobile teeth, fractures, severe bruxism, carious teeth, poor oral hygiene, teeth with irreversible pulpitis and endodontically treated teeth.
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 randomly receive one cervical restoration with one of the tested restorative systems | Other | Resin Modified Glass Ionomer cement, Self-Adhesive composite hybrid, Self-Adhesive flowable composite |
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 and USPHS parameters for each restorative system group
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Individual participant dataSharing planned: Yes
Related trials for Secondary Caries Dental Restoration Failure of Marginal Integrity
Active, not recruiting
Comparative Evaluation of Class V Restorations
Secondary Caries, Dental Restoration Failure of Marginal Integrity
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The Effect of Different Adhesion Strategies on the Clinical Success
Poor Aesthetic of Existing Restoration of Tooth, Dental Restoration Failure of Marginal Integrity
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.
Mohamed E Hamouda, Assistant 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 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 9 Aug 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed E Hamouda, Assistant Lecturer (01018357630, mohamedelbahloul@mans.edu.eg), or a site near the patient. 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 9 Aug 2024.