High Caries Risk PatientsNCT05744622
Clinical Evaluation of Chemically Cured Conventional Glass Ionomer After Light Emitting Diode Radiant Heat Enhancement
A study testing KetacTM Universal AplicapTM and KetacTM Universal AplicapTM with light cure in people with High Caries Risk Patients, run by Suez Canal University at 1 site in Egypt.
Trial summary
Introduction: Glass ionomer cements (GICs) are widely used in clinical dentistry due to their advantageous properties. However, they present inferior physical and mechanical properties compared to resin composites. Read more about this study
- Who is it for?
- Ages 21 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- High Caries Risk Patients
- What is being tested?
- KetacTM Universal AplicapTM and KetacTM Universal AplicapTM with light cure
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Feb 2021to 22 May 2022
- 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 21 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age group 21 - 45 years.
- Both males and females will be included.
- Ability to return for periodic follow-up (good general health).
- Only co-operative patients.
- Vital upper or lower carious posterior teeth.
Who cannot join
- Teeth with any pathologic pulpal disease.
- Teeth with previous restorations
- Teeth with surface loss due to attrition, erosion, abrasion, or abfraction.
- Patients with severe or chronic periodontitis.
- Patients have allergy to the materials used in this trial. 6- Nonfunctioning teeth with no opposing dentition.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of Chemically Cured Conventional Glass Ionomer After Light Emitting Diode Radiant Heat Enhancement: A Randomized Controlled Clinical Trial
Introduction:
Glass ionomer cements (GICs) are widely used in clinical dentistry due to their advantageous properties. However, they present inferior physical and mechanical properties compared to resin composites.
Read more
Aim:
Clinical evaluation of chemically cured conventional glass ionomer after light-emitting diode radiant heat enhancement. .
Methodology:
Eighteen healthy patients with 36-second molar teeth will be selected where each patient should have two oclusso- mesial cavities. Standardized oclusso- mesial cavities will be prepared for all the selected teeth, for each patient the first tooth will be restored with chemically cured conventional GICs without any enhancement (M1 group). Meanwhile, the second tooth will be restored by chemically cured conventional GICs that enhanced with radiant heat (LED) (M2 group). functional and biological criteria of each restoration will be clinically evaluated at 4 time points
Read the detailed description
Introduction:
Glass ionomer cements (GICs) are widely used in clinical dentistry due to their advantageous properties. However, they present inferior physical and mechanical properties compared to resin composites. Various techniques have been suggested to improve properties of conventional GICs such as radiant heat transfer by Light Emitting Diode (LED) or lasers, ultrasonic energy transfer also using of (CaCl2) solution.
Aim:
Clinical evaluation of chemically cured conventional glass ionomer after light-emitting diode radiant heat enhancement. .
Methodology:
Eighteen healthy patients with 36-second molar teeth will be selected where each patient should have two oclusso- mesial cavities. Standardized oclusso- mesial cavities will be prepared for all the selected teeth, for each patient the first tooth will be restored with chemically cured conventional GICs without any enhancement (M1 group). Meanwhile, the second tooth will be restored by chemically cured conventional GICs that enhanced with radiant heat (LED) (M2 group). functional and biological criteria of each restoration will be clinically evaluated immediately after restoration (T0), six months later (T1), and after 12 months (T2) using Federation Dentaire International (FDI) criteria for assessment of dental restorations.
- Conditions
- High Caries Risk Patients
- Being tested
- KetacTM Universal AplicapTM, KetacTM Universal AplicapTM with light cure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetacTM Universal AplicapTMOther
chemically cured conventional GICs
KetacTM Universal AplicapTM with light cureOther
chemically cured conventional GICs with light curing enhancement
| Study group | Role | What they receive |
|---|---|---|
| chemically cured conventional glass ionomer restorative (Ketac Universal Aplicap) | Experimental | For restoration of M1 group, capsule activation will be performed through loading of the KetacTM Universal AplicapTM GIC capsule into its activator keeping the applicator nozzle closed, using the ball of my hand to depress the activator lever firmly as far as it will go and hold it down for 2 to 4 seconds. Then the capsule will be mixed in a high frequency mixing device for 8 seconds. The mixed capsule will be immediately removed from the mixer and loaded into the AplicapTM Applier then application nozzle will be opened to extrude the mixture directly into the preparation as a single bulk within 1:40 minute. The preliminary contour will be done using a ball burnisher. Receives: Other: KetacTM Universal AplicapTM |
| Ketac Universal Aplicap enhanced with light-emitting diode radiant heat | Experimental | Restoration of M2 group will be performed following the same steps which will be carried out for M1 group but the achieved restorations will be enhanced by light-emitting diode radiant heat for 60 seconds Receives: Other: KetacTM Universal AplicapTM with light cure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical performance of biological properties
Clinical performance of biological properties according to FDI criteria
Measured: 12 months
Clinical performance of Functional properties
Clinical performance of Functional properties according to FDI criteria
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study start20 Feb 2021
- Primary completion20 Feb 2022
- Study completion22 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Caries Risk PatientsStudies of the same condition, open and under way.
- More trials run by Suez Canal 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, eman awad, Suez Canal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05744622
- Sponsor's protocol ID
- 431/2021
- Status last verified
- Feb 2023
- First submitted
- 15 Feb 2023
- Last updated
- 27 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Chemically Cured Conventional Glass Ionomer After Light Emitting Diode Radiant Heat Enhancement: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05744622
- Acronym / sponsor ID
- 431/2021
- Conditions
- High Caries Risk Patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- 20 Feb 2021 (actual)
- Primary completion
- 20 Feb 2022 (actual)
- Study completion
- 22 May 2022 (actual)
- First posted
- 27 Feb 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.
Introduction:
Glass ionomer cements (GICs) are widely used in clinical dentistry due to their advantageous properties. However, they present inferior physical and mechanical properties compared to resin composites.
Aim:
Clinical evaluation of chemically cured conventional glass ionomer after light-emitting diode radiant heat enhancement. .
Methodology:
Eighteen healthy patients with 36-second molar teeth will be selected where each patient should have two oclusso- mesial cavities. Standardized oclusso- mesial cavities will be prepared for all the selected teeth, for each patient the first tooth will be restored with chemically cured conventional GICs without any enhancement (M1 group). Meanwhile, the second tooth will be restored by chemically cured conventional GICs that enhanced with radiant heat (LED) (M2 group). functional and biological criteria of each restoration will be clinically evaluated at 4 time points
Detailed description
Introduction:
Glass ionomer cements (GICs) are widely used in clinical dentistry due to their advantageous properties. However, they present inferior physical and mechanical properties compared to resin composites. Various techniques have been suggested to improve properties of conventional GICs such as radiant heat transfer by Light Emitting Diode (LED) or lasers, ultrasonic energy transfer also using of (CaCl2) solution.
Aim:
Clinical evaluation of chemically cured conventional glass ionomer after light-emitting diode radiant heat enhancement. .
Methodology:
Eighteen healthy patients with 36-second molar teeth will be selected where each patient should have two oclusso- mesial cavities. Standardized oclusso- mesial cavities will be prepared for all the selected teeth, for each patient the first tooth will be restored with chemically cured conventional GICs without any enhancement (M1 group). Meanwhile, the second tooth will be restored by chemically cured conventional GICs that enhanced with radiant heat (LED) (M2 group). functional and biological criteria of each restoration will be clinically evaluated immediately after restoration (T0), six months later (T1), and after 12 months (T2) using Federation Dentaire International (FDI) criteria for assessment of dental restorations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| chemically cured conventional glass ionomer restorative (Ketac Universal Aplicap) | Experimental | Other: KetacTM Universal AplicapTMFor restoration of M1 group, capsule activation will be performed through loading of the KetacTM Universal AplicapTM GIC capsule into its activator keeping the applicator nozzle closed, using the ball of my hand to depress the activator lever firmly as far as it will go and hold it down for 2 to 4 seconds. Then the capsule will be mixed in a high frequency mixing device for 8 seconds. The mixed capsule will be immediately removed from the mixer and loaded into the AplicapTM Applier then application nozzle will be opened to extrude the mixture directly into the preparation as a single bulk within 1:40 minute. The preliminary contour will be done using a ball burnisher. |
| Ketac Universal Aplicap enhanced with light-emitting diode radiant heat | Experimental | Other: KetacTM Universal AplicapTM with light cureRestoration of M2 group will be performed following the same steps which will be carried out for M1 group but the achieved restorations will be enhanced by light-emitting diode radiant heat for 60 seconds |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age group 21 - 45 years.
- Both males and females will be included.
- Ability to return for periodic follow-up (good general health).
- Only co-operative patients.
- Vital upper or lower carious posterior teeth.
Key exclusion criteria (5 listed)
- Teeth with any pathologic pulpal disease.
- Teeth with previous restorations
- Teeth with surface loss due to attrition, erosion, abrasion, or abfraction.
- Patients with severe or chronic periodontitis.
- Patients have allergy to the materials used in this trial. 6- Nonfunctioning teeth with no opposing dentition.
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 |
|---|---|---|
| KetacTM Universal AplicapTMchemically cured conventional GICs | Other | chemically cured conventional glass ionomer restorative (Ketac Universal Aplicap) |
| KetacTM Universal AplicapTM with light curechemically cured conventional GICs with light curing enhancement | Other | Ketac Universal Aplicap enhanced with light-emitting diode radiant heat |
Primary outcome
Clinical performance of biological properties
Time frame: 12 months
Clinical performance of biological properties according to FDI criteria
Clinical performance of Functional properties
Time frame: 12 months
Clinical performance of Functional properties according to FDI 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 27 Feb 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KetacTM Universal AplicapTM and KetacTM Universal AplicapTM with light cure in people with High Caries Risk Patients, run by Suez Canal 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 5 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 27 Feb 2023. 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?
Clinical performance of biological properties (time frame: 12 months). The study lists 2 primary outcomes in all. 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 27 Feb 2023.