Dental CariesBIRCRMGILYCTNCT05470959
Bioactive Composite Versus Resin-Modified Glass Ionomer Liners: 2-Year Clinical Trial
A study testing ACTIVA bioactive and Riva LC in people with Dental Caries, run by Mansoura University at 1 site in Egypt.
Trial summary
compare 2-year clinical performance of recent bioactive ionic resin composite to resin-modified glass ionomer liner in indirect dental pulp treatment. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- ACTIVA bioactive and Riva LC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Oct 2019to 20 Dec 2021
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- presence of two deep carious lesions, one on each side of the mouth (ICDAS 5 or 6)
- vital teeth
- no sensitivity to teeth percussion
- no spontaneous pain
- no radiolucency in the periapical or furcation area of teeth
- complete and normal occlusion
- good oral hygiene
Who cannot join
- poor oral hygiene
- severe or chronic periodontal problems
- periapical lesions
- heavy bruxism
- non-vital teeth
- visibly cracked teeth
- spontaneous dental pain
- sensitivity to teeth percussion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bioactive Ionic Resin Composite Versus Resin-Modified Glass Ionomer Cavity Liners: 2-Year Randomized Clinical Trial
compare 2-year clinical performance of recent bioactive ionic resin composite to resin-modified glass ionomer liner in indirect dental pulp treatment.
Read the detailed description
patients were enrolled in the clinical trial. Each patient had two deep carious lesions, one on each side of the mouth. After selective caries removal, cavities were lined with bioactive ionic resin composite (Activa Bioactive Liner/Base) or resin-modified glass ionomer liner (Riva Light Cure RMGI). All cavities were then restored with nanofilled resin composite (Filtek Z350xt). All materials were placed according to the manufacturers' instructions. Clinical evaluation was accomplished using World Dental Federation (FDI) criteria at baseline and after 6 months, one year, one and half years, and two years.
- Conditions
- Dental Caries
- Being tested
- ACTIVA bioactive, Riva LC
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACTIVA bioactiveOther
bioactive ionic resin composite
Riva LCOther
Also called Riva light cure
resin-modified glass ionomer
| Study group | Role | What they receive |
|---|---|---|
| ACTIVA bioactive | Other | bioactive ionic resin composite Receives: Other: ACTIVA bioactive |
| Riva LC | Other | Resin-modifed glass ionomer Receives: Other: Riva LC |
What is being measured
The primary outcome is the main question the study is designed to answer.
assess clinical performance of bioactive ionic resin composite and resin-modified glass ionomer liner by using FDI clinical criteria
comparison of 2-year clinical performance of recent bioactive ionic resin composite( ACTIVA bioactive) to resin-modified glass ionomer liner ( Riva LC) in indirect dental pulp treatment using FDI world dental federation clinical criteria.
Measured: 2-years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2022
- Study start10 Oct 2019
- Primary completion30 Oct 2021
- Study completion20 Dec 2021
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 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, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- salah mahmoud, professor, Study director, faculty of dentistry, mansoura university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05470959
- Sponsor's protocol ID
- M19091019
- Acronym
- BIRCRMGILYCT
- Status last verified
- Jul 2022
- First submitted
- 19 Jul 2022
- Last updated
- 22 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ahmed B, Wafaie RA, Hamama HH, Mahmoud SH. 3-year randomized clinical trial to evaluate the performance of posterior composite restorations lined with ion-releasing materials. Sci Rep. 2024 Feb 28;14(1):4942. doi: 10.1038/s41598-024-55329-6.
PubMed 38418863
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioactive Ionic Resin Composite Versus Resin-Modified Glass Ionomer Cavity Liners: 2-Year Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05470959
- Acronym / sponsor ID
- BIRCRMGILYCT / M19091019
- Conditions
- Dental Caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 10 Oct 2019 (actual)
- Primary completion
- 30 Oct 2021 (actual)
- Study completion
- 20 Dec 2021 (actual)
- First posted
- 22 Jul 2022 (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.
compare 2-year clinical performance of recent bioactive ionic resin composite to resin-modified glass ionomer liner in indirect dental pulp treatment.
Detailed description
patients were enrolled in the clinical trial. Each patient had two deep carious lesions, one on each side of the mouth. After selective caries removal, cavities were lined with bioactive ionic resin composite (Activa Bioactive Liner/Base) or resin-modified glass ionomer liner (Riva Light Cure RMGI). All cavities were then restored with nanofilled resin composite (Filtek Z350xt). All materials were placed according to the manufacturers' instructions. Clinical evaluation was accomplished using World Dental Federation (FDI) criteria at baseline and after 6 months, one year, one and half years, and two years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACTIVA bioactive | Other | Other: ACTIVA bioactivebioactive ionic resin composite |
| Riva LC | Other | Other: Riva LCResin-modifed glass ionomer |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- presence of two deep carious lesions, one on each side of the mouth (ICDAS 5 or 6)
- vital teeth
- no sensitivity to teeth percussion
- no spontaneous pain
- no radiolucency in the periapical or furcation area of teeth
Key exclusion criteria (8 listed)
- poor oral hygiene
- severe or chronic periodontal problems
- periapical lesions
- heavy bruxism
- non-vital 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 |
|---|---|---|
| ACTIVA bioactivebioactive ionic resin composite | Other | ACTIVA bioactive |
| Riva LCAlso: Riva light cureresin-modified glass ionomer | Other | Riva LC |
Primary outcome
assess clinical performance of bioactive ionic resin composite and resin-modified glass ionomer liner by using FDI clinical criteria
Time frame: 2-years
comparison of 2-year clinical performance of recent bioactive ionic resin composite( ACTIVA bioactive) to resin-modified glass ionomer liner ( Riva LC) in indirect dental pulp treatment using FDI world dental federation clinical criteria.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2022.
- Derived from this study: PubMed 38418863Ahmed B, Wafaie RA, Hamama HH, Mahmoud SH. 3-year randomized clinical trial to evaluate the performance of posterior composite restorations lined with ion-releasing materials. Sci Rep. 2024 Feb 28;14(1):4942. doi: 10.1038/s41598-024-55329-6.
- Individual participant dataSharing planned: No
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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.
salah mahmoud, professor study director
faculty of dentistry, mansoura university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACTIVA bioactive and Riva LC in people with Dental Caries, 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 7 inclusion and 8 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: finished, as of the sponsor's last update on 22 Jul 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
assess clinical performance of bioactive ionic resin composite and resin-modified glass ionomer liner by using FDI clinical criteria (time frame: 2-years). 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 NCT05470959, 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 22 Jul 2022; AzTrials last refreshed its copy on 6 Nov 2026.