Secondary Dental CariesNCT05332041
Assessment of Bioactive Bulk Fill Composite Versus High Viscosity Glass Ionomer Restorations for Carious Lesions
A study testing Predicta Bioactive bulk fil composite restoration in people with Secondary Dental Caries, run by Cairo University.
Trial summary
This trial will be conducted to compare the clinical performance between a new bioactive resin composite material and high viscosity glass ionomer for restoring occlusal carious lesions of posterior teeth in patients scheduled for head and neck radiotherapy. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Secondary Dental Caries
- What is being tested?
- Predicta Bioactive bulk fil composite restoration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2022to 1 Sep 2023
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient inclusion:
- Patients Scheduled for head and neck radiotherapy.
- age: ≥18 years.
- Patients with good likelihood of recall availability.
- Tooth inclusion:
- Permanent premolars or molars.
Show all 9Show fewer
- Primary occlusal carious lesions.
- Vital with positive reaction to cold thermal stimulus.
- Well-formed and fully-erupted.
Who cannot join
- Participants with late stage head and neck cancer
- Concomitant participation in another research study.
- Inability to comply with study procedures
- past experience with allergic reactions against any components of the used materials Teeth with clinical symptoms of pulpitis such as spontaneous pain or sensitivity to pressure.
- N 2-Non-vital teeth. 3-Secondary carious lesions
- -
About this study
Official title: Clinical Assessment of Bioactive Bulk Fill Composite Versus High Viscosity Glass Ionomer Restorations for Restoring Occlusal Carious Lesions of Posterior Teeth in Patients Scheduled for Head and Neck Radiotherapy
This trial will be conducted to compare the clinical performance between a new bioactive resin composite material and high viscosity glass ionomer for restoring occlusal carious lesions of posterior teeth in patients scheduled for head and neck radiotherapy.
Read the detailed description
Inspite of recent developments in the materials' science, some novel materials require direct association with components of the oral cavity for renewal or recharging of the constituents of the restoration to enhance marginal integrity and thus decrease bacterial microleakage, marginal discoloration and postoperative hypersensitivity . There is a constant increase in aesthetic demand for a material that ensures near to perfect adhesion to the tooth surface in order to minimize microleakage and improve marginal integrity. Microleakage forms the basis for predicting the performance of any restorative material Bioactive restorative materials have been introduced for numerous utilizations in dentistry. Among these are fluorides for remineralization; antibacterial resins and restoratives that release and recharge fluorides, phosphate and hydroxyle ions and thus can enhance marginal integrity . Bioactive restorative materials are reported to release more fluoride than glass ionomers. Additionally, they react to pH changes in the mouth by uptaking calcium, phosphate, and fluoride ions to maintain the chemical integrity of the tooth structure.
It is proposed that contemporary bioactive esthetic materials, which associate with oral fluids and show recharge and renewal of restorative material constituents, have the potential to reduce bacterial microleakage and enhance marginal integrity, One possible approach to increase the resistance of restorations to secondary caries formation is to use bioactive materials ( Like predicta bilk fil composite) that contain agents which negatively influence the micro-organisms and/or promote remineralization of tooth structure.
High viscosity glass ionomer (EQUIA Fil) has new technology that contains ultrafine and highly reactive glass diffused within the glass-ionomer fillers to increase and enhance matrix formation. This system allows ion availability and builds a stronger matrix structure with greater physical properties, wear resistance and fluoride release.
- Conditions
- Secondary Dental Caries
- Being tested
- Predicta Bioactive bulk fil composite restoration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Predicta Bioactive bulk fil composite restorationOther
Predicta Bioactive bulk fil resin composite restoration material
| Study group | Role | What they receive |
|---|---|---|
| Predicta Bioactive bulk fil composite restoration | Experimental | Bioactive bulk fil resin composite dental restoration material Receives: Other: Predicta Bioactive bulk fil composite restoration |
| High viscosity glass ionomer (Equia Fil) | Active comparator | High viscosity dental restoration material Receives: Other: Predicta Bioactive bulk fil composite restoration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Secondary caries
biological outcome
Measured: one year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2022
- Study start1 Jul 2022 (estimated)
- Primary completion1 Jul 2023 (estimated)
- Study completion1 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Secondary Dental CariesStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neven Ahmed Ebrahim, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05332041
- Sponsor's protocol ID
- USPHS criteria
- Status last verified
- Apr 2022
- First submitted
- 6 Apr 2022
- Last updated
- 18 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Assessment of Bioactive Bulk Fill Composite Versus High Viscosity Glass Ionomer Restorations for Restoring Occlusal Carious Lesions of Posterior Teeth in Patients Scheduled for Head and Neck Radiotherapy
- ClinicalTrials.gov ID
- NCT05332041
- Acronym / sponsor ID
- USPHS criteria
- Conditions
- Secondary Dental Caries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (estimated)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 18 Apr 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.
This trial will be conducted to compare the clinical performance between a new bioactive resin composite material and high viscosity glass ionomer for restoring occlusal carious lesions of posterior teeth in patients scheduled for head and neck radiotherapy.
Detailed description
Inspite of recent developments in the materials' science, some novel materials require direct association with components of the oral cavity for renewal or recharging of the constituents of the restoration to enhance marginal integrity and thus decrease bacterial microleakage, marginal discoloration and postoperative hypersensitivity . There is a constant increase in aesthetic demand for a material that ensures near to perfect adhesion to the tooth surface in order to minimize microleakage and improve marginal integrity. Microleakage forms the basis for predicting the performance of any restorative material Bioactive restorative materials have been introduced for numerous utilizations in dentistry. Among these are fluorides for remineralization; antibacterial resins and restoratives that release and recharge fluorides, phosphate and hydroxyle ions and thus can enhance marginal integrity . Bioactive restorative materials are reported to release more fluoride than glass ionomers. Additionally, they react to pH changes in the mouth by uptaking calcium, phosphate, and fluoride ions to maintain the chemical integrity of the tooth structure.
It is proposed that contemporary bioactive esthetic materials, which associate with oral fluids and show recharge and renewal of restorative material constituents, have the potential to reduce bacterial microleakage and enhance marginal integrity, One possible approach to increase the resistance of restorations to secondary caries formation is to use bioactive materials ( Like predicta bilk fil composite) that contain agents which negatively influence the micro-organisms and/or promote remineralization of tooth structure.
High viscosity glass ionomer (EQUIA Fil) has new technology that contains ultrafine and highly reactive glass diffused within the glass-ionomer fillers to increase and enhance matrix formation. This system allows ion availability and builds a stronger matrix structure with greater physical properties, wear resistance and fluoride release.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Predicta Bioactive bulk fil composite restoration | Experimental | Other: Predicta Bioactive bulk fil composite restorationBioactive bulk fil resin composite dental restoration material |
| High viscosity glass ionomer (Equia Fil) | Active comparator | Other: Predicta Bioactive bulk fil composite restorationHigh viscosity dental restoration material |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients Scheduled for head and neck radiotherapy.
- age: ≥18 years.
- Patients with good likelihood of recall availability.
- Permanent premolars or molars.
- Primary occlusal carious lesions.
Key exclusion criteria (6 listed)
- Participants with late stage head and neck cancer
- Concomitant participation in another research study.
- Inability to comply with study procedures
- past experience with allergic reactions against any components of the used materials Teeth with clinical symptoms of pulpitis such as spontaneous pain or sensitivity to pressure.
- N 2-Non-vital teeth. 3-Secondary carious lesions
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 |
|---|---|---|
| Predicta Bioactive bulk fil composite restorationPredicta Bioactive bulk fil resin composite restoration material | Other | High viscosity glass ionomer (Equia Fil), Predicta Bioactive bulk fil composite restoration |
Primary outcome
Secondary caries
Time frame: one year follow up
biological outcome
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2022.
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Comparative Evaluation of Class V Restorations
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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 Predicta Bioactive bulk fil composite restoration in people with Secondary Dental Caries, 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 9 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 18 Apr 2022. 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?
Secondary caries (time frame: one year follow up). 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 18 Apr 2022.