Demineralization, ToothNCT04052802
Compariing a Bioactive Resin Material Used As A Fissure Sealant To A Conventional Resin
A study testing Fissure sealing in people with Demineralization, Tooth and Demineralization, Fissure, run by Cairo University.
Trial summary
The aim of this study is to investigate the retention, marginal integrity and potential to prevent lesion progression of a bioactive resin material compared to a conventional resin-based flowable composite during management of initial carious lesion in adult population over an 18 months period. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Demineralization, Tooth, Demineralization, Fissure, Non-Cavitated Caries
- What is being tested?
- Fissure sealing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 30 Aug 2019to 30 Apr 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with good oral hygiene
- Co-operative patients with initially demineralized fissures in permanent molars of the maxilla or mandible
Who cannot join
- Medical Problems or Pregnancy
- Lack of patient's approval and compliance
- Presence of abnormal oral, medical, or mental condition
- Known allergy of resin-based materials
- Previous placements of sealants or restorations
- Bruxism or mal-occlusion
About this study
Official title: The Efficacy Of A Bioactive Resin Material Used As A Fissure Sealant As Compared To A Conventional Resin Regarding Its Retention, Marginal Integrity And Prevention Of Lesion Progression. A Randomized Clinical Study
The aim of this study is to investigate the retention, marginal integrity and potential to prevent lesion progression of a bioactive resin material compared to a conventional resin-based flowable composite during management of initial carious lesion in adult population over an 18 months period.
Read the detailed description
Bio-active resin materials aim to possess the mechanical properties of resin materials in terms of higher wear resistance and dimensional stability over time. They also aim to mimic the biological activity of glass ionomers in terms of ion recharge and release. These new bio-active resin materials, with their lower particle size and better adaptability and polishability, might offer a substantial addition as fissure sealants if they fulfil the requisities satisfactory mechanical properties of resins and of ion recharge and release of glass ionomers.
The study will be conducted on demineralized fissures of permanent molars by application of a newly introduced giomer in one group while the other group will recieve a conventional resin material where they will be assessed for retention, marginal integrity and caries progression.
- Being tested
- Fissure sealing
- Medical subject headings
- Tooth Demineralization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fissure sealingOther
The materials will be applied to the demineralized fissures as stated in manufacturer's instructions
| Study group | Role | What they receive |
|---|---|---|
| Bioactive resin (Giomer) | Experimental | This group of patients will receive a bioactive resin "Beautifil flow plus X (Shofu Dental)" for treatment of their demineralized fissures Receives: Other: Fissure sealing |
| Conventional resin | Experimental | This group of patients will receive a conventional resin "Filtek Z350xt Flowable composite (3M ESPE)" for treatment of their demineralized fissures Receives: Other: Fissure sealing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention
The sealing materials will be assessed for complete, partial or no retention. The assessment will be carried out by visual and tactile assessments and calculated as a percentage of the total sample.
Measured: 18 months
Secondary outcomes (2)
Marginal integrity
The materials margins will be assessed for their marginal seal using FDI criteria using a WHO probe. Scoring will be made from 1-5 by FDI criteria then statistically analyzed
Measured: 18 months
Caries progression
The demineralized fissures will be monitored for caries arrest or progression. The assessment will be made by ICDAS II criteria comparing the scores from baseline.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2019
- Study start30 Aug 2019 (estimated)
- Primary completion30 Mar 2021 (estimated)
- Study completion30 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Demineralization, ToothStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Khaled Mostafa, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04052802
- Sponsor's protocol ID
- 812014
- Status last verified
- Aug 2019
- First submitted
- 5 Aug 2019
- Last updated
- 12 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will be assessed collectively for ll participants and statistically analyzed and published with the results. Other data can be provided apon request if ethically approved.
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy Of A Bioactive Resin Material Used As A Fissure Sealant As Compared To A Conventional Resin Regarding Its Retention, Marginal Integrity And Prevention Of Lesion Progression. A Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT04052802
- Acronym / sponsor ID
- 812014
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Aug 2019 (estimated)
- Primary completion
- 30 Mar 2021 (estimated)
- Study completion
- 30 Apr 2021 (estimated)
- First posted
- 12 Aug 2019 (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 aim of this study is to investigate the retention, marginal integrity and potential to prevent lesion progression of a bioactive resin material compared to a conventional resin-based flowable composite during management of initial carious lesion in adult population over an 18 months period.
Detailed description
Bio-active resin materials aim to possess the mechanical properties of resin materials in terms of higher wear resistance and dimensional stability over time. They also aim to mimic the biological activity of glass ionomers in terms of ion recharge and release. These new bio-active resin materials, with their lower particle size and better adaptability and polishability, might offer a substantial addition as fissure sealants if they fulfil the requisities satisfactory mechanical properties of resins and of ion recharge and release of glass ionomers.
The study will be conducted on demineralized fissures of permanent molars by application of a newly introduced giomer in one group while the other group will recieve a conventional resin material where they will be assessed for retention, marginal integrity and caries progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bioactive resin (Giomer) | Experimental | Other: Fissure sealingThis group of patients will receive a bioactive resin "Beautifil flow plus X (Shofu Dental)" for treatment of their demineralized fissures |
| Conventional resin | Experimental | Other: Fissure sealingThis group of patients will receive a conventional resin "Filtek Z350xt Flowable composite (3M ESPE)" for treatment of their demineralized fissures |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients with good oral hygiene
- Co-operative patients with initially demineralized fissures in permanent molars of the maxilla or mandible
Key exclusion criteria (6 listed)
- Medical Problems or Pregnancy
- Lack of patient's approval and compliance
- Presence of abnormal oral, medical, or mental condition
- Known allergy of resin-based materials
- Previous placements of sealants or restorations
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 |
|---|---|---|
| Fissure sealingThe materials will be applied to the demineralized fissures as stated in manufacturer's instructions | Other | Bioactive resin (Giomer), Conventional resin |
Primary outcome
Retention
Time frame: 18 months
The sealing materials will be assessed for complete, partial or no retention. The assessment will be carried out by visual and tactile assessments and calculated as a percentage of the total sample.
2 secondary outcomes
Marginal integrity
Time frame: 18 months
Caries progression
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2019.
- Individual participant dataSharing planned: No. The data will be assessed collectively for ll participants and statistically analyzed and published with the results. Other data can be provided apon request if ethically approved.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Fissure sealing in people with Demineralization, Tooth and Demineralization, Fissure, run by Cairo University.
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 2 inclusion and 6 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 12 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Retention (time frame: 18 months). 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 12 Aug 2019.