Dental CariesNCT04854655
Evaluation of Ion Releasing Hybrid Restorative Material
A study testing Conventional resin composite, Activa Presto and Giomer in people with Dental Caries, run by Cairo University.
Trial summary
Esthetic and mechanical evaluation of calcium and phosphate releasing hybrid restorative material and fluoride releasing hybrid restorative material versus the conventional nanofilled resin composite in proximal carious lesions over 1 year follow-up according to the USPHS criteria. Read more about this study
- Who is it for?
- Ages 25 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- Conventional resin composite, Activa Presto and Giomer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 10 Oct 2021to 30 Oct 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 25 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patient-related criteria:
- Patients consulting in one of the outpatient clinics listed above.
- Patients can tolerate necessary restorative procedures.
- Provide informed consent.
- Patients accept the one year follow-up period.
- Patients are within middle age group (25-40years).
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- Cooperative patients.
- Patients don't have any medically compromised conditions.
- Tooth related criteria:
- Teeth with primary proximal carious lesions in posterior teeth with no pulpal involvement.
- Teeth should have contact with the adjacent teeth.
- Teeth are vital according to pulp-sensitivity tests.
- No active gingival or periodontal conditions.
Who cannot join
- • Medically compromised patients, as they will not be able to attend multiple appointments or may require special management.
- Pregnant women; as radiographs are prohibited.
- Allergic Patients to any of the restorative materials, including anesthetics.
- Uncooperative patients will not follow the instructions or attend the appointments.
- Tooth related criteria:
- Retained deciduous teeth; as the research is targeting only permanent teeth.
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- Teeth with previous restorations, which may add another variable to the study (type of old restorative material, extent of recurrent caries).
- Spontaneous pain or prolonged pain after sensitivity tests (cold and electrical tests) indicating irreversible pulpitis.
- Negative sensitivity tests, periapical radiolucencies, and sensitivity to axial or lateral percussion indicating pulp necrosis.
- Teeth presenting external or internal resorption, with adverse pulpal reactions which may affect the outcome of the study.
- Teeth with cervical caries; which can't be evaluated on periapical radiographs.
About this study
Official title: Evaluation of Calcium and Phosphate Releasing Hybrid Restorative Material and Fluoride Releasing Hybrid Restorative Material Versus the Conventional Resin Composite in Proximal Carious Lesions Over One Year Follow-up Using USPHS Criteria
Esthetic and mechanical evaluation of calcium and phosphate releasing hybrid restorative material and fluoride releasing hybrid restorative material versus the conventional nanofilled resin composite in proximal carious lesions over 1 year follow-up according to the USPHS criteria.
Read the detailed description
3 groups of 45 patients will receive class II restorations by using calcium and phosphate releasing hybrid restorative material (Activa Presto), fluoride releasing hybrid restorative material (Giomer), and conventional nanofilled resin composite. Then these restorations evaluated at 24 hours after placement, 1 month, 3 months, 6 months and 12 months according the modified USPHS criteria in terms of fracture, marginal adaptation, retention, anatomic form, marginal discoloration, surface texture, and color match.
- Conditions
- Dental Caries
- Being tested
- Conventional resin composite, Activa Presto, Giomer
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional resin compositeOther
nanofilled resin composite
Activa PrestoOther
calcium and phosphate hybrid material
GiomerOther
fluoride releasing hybrid material
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Conventional resin composite Receives: Other: Conventional resin composite |
| Intervention 1 | Experimental | Activa Presto Receives: Other: Activa Presto |
| Intervention 2 | Experimental | Giomer Receives: Other: Giomer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mechanical evaluation according to USPHS criteria
Fracture, Retention, Marginal adaptation, Anatomic form, and Surface roughness
Measured: 1 year
Secondary outcomes (1)
: Esthetic evaluation according to USPHS criteria. : Esthetic evaluation according to USPHS criteria. Esthetic evaluation according to USPHS criteria
Color match, marginal discoloration, and restoration color stability
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2021
- Study start10 Oct 2021 (estimated)
- Primary completion10 Oct 2022 (estimated)
- Study completion30 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nouran Osama El-Sayed Ahmed Abou El-Nour, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04854655
- Sponsor's protocol ID
- 1994
- Status last verified
- Sep 2021
- First submitted
- 20 Apr 2021
- Last updated
- 9 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Calcium and Phosphate Releasing Hybrid Restorative Material and Fluoride Releasing Hybrid Restorative Material Versus the Conventional Resin Composite in Proximal Carious Lesions Over One Year Follow-up Using USPHS Criteria
- ClinicalTrials.gov ID
- NCT04854655
- Acronym / sponsor ID
- 1994
- Conditions
- Dental Caries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Oct 2021 (estimated)
- Primary completion
- 10 Oct 2022 (estimated)
- Study completion
- 30 Oct 2022 (estimated)
- First posted
- 22 Apr 2021 (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.
Esthetic and mechanical evaluation of calcium and phosphate releasing hybrid restorative material and fluoride releasing hybrid restorative material versus the conventional nanofilled resin composite in proximal carious lesions over 1 year follow-up according to the USPHS criteria.
Detailed description
3 groups of 45 patients will receive class II restorations by using calcium and phosphate releasing hybrid restorative material (Activa Presto), fluoride releasing hybrid restorative material (Giomer), and conventional nanofilled resin composite. Then these restorations evaluated at 24 hours after placement, 1 month, 3 months, 6 months and 12 months according the modified USPHS criteria in terms of fracture, marginal adaptation, retention, anatomic form, marginal discoloration, surface texture, and color match.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: Conventional resin compositeConventional resin composite |
| Intervention 1 | Experimental | Other: Activa PrestoActiva Presto |
| Intervention 2 | Experimental | Other: GiomerGiomer |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Patient-related criteria:
- Teeth with primary proximal carious lesions in posterior teeth with no pulpal involvement.
- Teeth should have contact with the adjacent teeth.
- Teeth are vital according to pulp-sensitivity tests.
- No active gingival or periodontal conditions.
Key exclusion criteria (11 listed)
- • Medically compromised patients, as they will not be able to attend multiple appointments or may require special management.
- Retained deciduous teeth; as the research is targeting only permanent teeth.
- Teeth with previous restorations, which may add another variable to the study (type of old restorative material, extent of recurrent caries).
- Spontaneous pain or prolonged pain after sensitivity tests (cold and electrical tests) indicating irreversible pulpitis.
- Negative sensitivity tests, periapical radiolucencies, and sensitivity to axial or lateral percussion indicating pulp necrosis.
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 |
|---|---|---|
| Conventional resin compositenanofilled resin composite | Other | Control |
| Activa Prestocalcium and phosphate hybrid material | Other | Intervention 1 |
| Giomerfluoride releasing hybrid material | Other | Intervention 2 |
Primary outcome
Mechanical evaluation according to USPHS criteria
Time frame: 1 year
Fracture, Retention, Marginal adaptation, Anatomic form, and Surface roughness
1 secondary outcome
: Esthetic evaluation according to USPHS criteria. : Esthetic evaluation according to USPHS criteria. Esthetic evaluation according to USPHS criteria
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2021.
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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 Conventional resin composite, Activa Presto and Giomer in people with 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 13 inclusion and 11 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 9 Sep 2021. 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?
Mechanical evaluation according to USPHS criteria (time frame: 1 year). 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 9 Sep 2021.