Resin CementPhase 1NCT04557657
Evaluation of Marginal Integrity Using Bioactive Cement Incementation of Indirect Composite Blocks
A Phase 1 study testing Active bio Activa and Resin Cement in people with Resin Cement, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate of marginal integrity of indirect composite restoration after cementation by a bioactive cement in comparison to dual cure resin cement using Modified USPHS criteria Read more about this study
- Who is it for?
- Ages 16 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Resin Cement
- What is being tested?
- Active bio Activa and Resin Cement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2019to Mar 2021
- Phase
- Phase 1
- 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 16 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients with badly broken vital teeth with minimum of two remaining walls
- Adult Males or female 16- 65 years old
- Good oral hygiene measures with a good gingival condition
- Cooperative patients approving to participate in the study
- Free of any medical condition that interfere with procedures
Who cannot join
- Patients with a compromised medical history.
- Severe or active periodontal disease
- Endodontically treated teeth
- Severe medical complications Lack of compliance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Marginal Integrity Using Modified USPHS Criteria of a Bioactive Cement in Comparison to Resin Cement in Cementation of Indirect Composite Blocks: A Randomized Clinical Trial 12 Month Follow up
The aim of this study is to evaluate of marginal integrity of indirect composite restoration after cementation by a bioactive cement in comparison to dual cure resin cement using Modified USPHS criteria
Read the detailed description
The study will be conducted in Conservative Dentistry Department, Faculty of Dentistry, Cairo University, The operator in charge will be: Mohamed Sherif . The researcher will bear ultimate responsibility for all activities associated with the conduct of a research project including recruitment of patients, explaining and performing the procedures to them,A total of 36 volunteer patients with Patients with badly broken vital teeth with minimum of two remaining walls. Patients will be randomly divided into two groups according to type of cement (S) where in group S1, Restoration will be cemented with resin cement ; while group S2,Restoration will be cemented with active cement. Each restoration will be assessed after three, six months and one year using modified USPH Criteria Marginal Discoloration, Recurrent Caries and Marginal Chipping with scale of Alpha and non alpha
- Conditions
- Resin Cement
- Being tested
- Active bio Activa, Resin Cement
- Keywords
- Composite blocks, Cad/Cam, Cerec
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active bio ActivaDrug
Also called Active Cement Pulpodent
Cement that release fluoride
Resin CementDrug
Resin Cement Convinonal
| Study group | Role | What they receive |
|---|---|---|
| Control Group Resin cement | Experimental | Control group Using resin cement Receives: Drug: Resin Cement |
| Intervention Group Active Cement | Active comparator | Intervention Group Using active cement bio activa Receives: Drug: Active bio Activa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal Discoloration
Check Marginal Discoloration Using Modified USPH 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 posted21 Sep 2020
- Study start1 Sep 2019
- Primary completion30 Oct 2019
- Study completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resin CementStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 36 volunteer assigned randomly into 2 equal groups of 18
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Sherif, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04557657
- Sponsor's protocol ID
- CEBD-CU-2019-07-17
- Status last verified
- Jan 2021
- First submitted
- 11 Sep 2020
- Last updated
- 28 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual patient Data can be shared Upon request
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Marginal Integrity Using Modified USPHS Criteria of a Bioactive Cement in Comparison to Resin Cement in Cementation of Indirect Composite Blocks: A Randomized Clinical Trial 12 Month Follow up
- ClinicalTrials.gov ID
- NCT04557657
- Acronym / sponsor ID
- CEBD-CU-2019-07-17
- Conditions
- Resin Cement
- Keywords
- Composite blocks, Cad/Cam, Cerec
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 30 Oct 2019 (actual)
- Study completion
- Mar 2021 (estimated)
- First posted
- 21 Sep 2020 (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 evaluate of marginal integrity of indirect composite restoration after cementation by a bioactive cement in comparison to dual cure resin cement using Modified USPHS criteria
Detailed description
The study will be conducted in Conservative Dentistry Department, Faculty of Dentistry, Cairo University, The operator in charge will be: Mohamed Sherif . The researcher will bear ultimate responsibility for all activities associated with the conduct of a research project including recruitment of patients, explaining and performing the procedures to them,A total of 36 volunteer patients with Patients with badly broken vital teeth with minimum of two remaining walls. Patients will be randomly divided into two groups according to type of cement (S) where in group S1, Restoration will be cemented with resin cement ; while group S2,Restoration will be cemented with active cement. Each restoration will be assessed after three, six months and one year using modified USPH Criteria Marginal Discoloration, Recurrent Caries and Marginal Chipping with scale of Alpha and non alpha
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 36 volunteer assigned randomly into 2 equal groups of 18
| Arm | Type | Receives |
|---|---|---|
| Control Group Resin cement | Experimental | Drug: Resin CementControl group Using resin cement |
| Intervention Group Active Cement | Active comparator | Drug: Active bio ActivaIntervention Group Using active cement bio activa |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with badly broken vital teeth with minimum of two remaining walls
- Adult Males or female 16- 65 years old
- Good oral hygiene measures with a good gingival condition
- Cooperative patients approving to participate in the study
- Free of any medical condition that interfere with procedures
Key exclusion criteria (4 listed)
- Patients with a compromised medical history.
- Severe or active periodontal disease
- Endodontically treated teeth
- Severe medical complications Lack of compliance
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 |
|---|---|---|
| Active bio ActivaAlso: Active Cement PulpodentCement that release fluoride | Drug | Intervention Group Active Cement |
| Resin CementResin Cement Convinonal | Drug | Control Group Resin cement |
Primary outcome
Marginal Discoloration
Time frame: 12 Months
Check Marginal Discoloration Using Modified USPH criteria
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2021.
- Individual participant dataSharing planned: Yes. Individual patient Data can be shared Upon request
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Predictable Method for Restoring Endodontically Treated Teeth, Comparing Indirect and Direct Methods and Materials in Aesthetic Dentistry.
Endodontically Treated Teeth Requiring Indirect Restorative Treatment
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An In-vivo Survival Rate of Different Onlay Materials Placed Over Endodontically Treated Molar Teeth
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Root Coverage Performance of Restorative Materials in Class V Cavities
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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 Phase 1 study testing Active bio Activa and Resin Cement in people with Resin Cement, run by Cairo 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 4 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 28 Jan 2021. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Marginal Discoloration (time frame: 12 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 28 Jan 2021.