Class V Dental CariesNCT06736964
Clinical Evaluation of Different Bioactive Restorative Materials for Cervical Carious in High Caries Risk Patients
A study testing Giomer in people with Class V Dental Caries and High Caries Risk Patients, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of the study is to clinically evaluate three different bioactive restorative material in cervical carious lesion in high caries risk patients. Reducing the incidence of recurrent caries is the primary outcome Read more about this study
- Who is it for?
- Ages 25 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Class V Dental Caries, High Caries Risk Patients
- What is being tested?
- Giomer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2024to 1 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patient age range from 25-45 year.
- High risk caries.
- Patients required at least a couple of Class V restorations.
- The depth of lesion should be(1.5- 2 mm) .
- The patient should have good general health
Who cannot join
- Poor oral hygiene.
- Sever or chronic periodontal disease or Bruxism.
- Severe tooth sensitivity.
- Non-vital or fracture or cracked teeth.
- Defective restorations, orthodontic treatment or bleaching procedures during the last 6 months.
- pregnancy, and/or lactation, and allergy to the main components of the products to be used in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical Evaluation of Different Bioactive Restorative Materials for Cervical Carious in High Caries Risk Patients :A Randomized Clinical Trial
The aim of the study is to clinically evaluate three different bioactive restorative material in cervical carious lesion in high caries risk patients.
Reducing the incidence of recurrent caries is the primary outcome
Read the detailed description
Bioactive restorative materials are relatively new concept in dentistry combines between esthetics, strength and resilience of composites with bioactive properties, the development of therapeutic bio-interactive materials results in tissue re-mineralization, reduces the susceptibility to tooth mineral loss, and recovers its mechanical properties .
Patients, with high caries, have many risk factors like inadequate biofilm control, salivary flow deficiency, and altered host defense. Conventional restorative materials expose the tooth structure to stress concentration. Moreover, preserving the tooth restoration interface intact is great challenge to avoid recurrent caries, which may also result in restoration failures .
This prospective study will be investigating and comparing the eighteen month clinical performance of a different bioactive restorative materials and a conventional Pre-reacted glass ionomer restorative material in class V cavity preparation.
- Conditions
- Class V Dental Caries, High Caries Risk Patients
- Being tested
- Giomer
- Keywords
- bioactive restorative material, dual cure bulk fill bio-active restoration, Pre-reacted glass ionomer (PRG) Giomer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GiomerDevice
based on Pre-reacted glass ionomer (PRG)
| Study group | Role | What they receive |
|---|---|---|
| Predicta | Experimental | based on dual cure bulk fill bioactive restoration Receives: Device: Giomer |
| Activa presto | Experimental | based on Bio-glass reinforced glass Ionomer Receives: Device: Giomer |
| Giomer | Active comparator | based on Pre-reacted glass ionomer (PRG) Receives: Device: Giomer |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical performance (Post operative hyper sensitivity)
method of measurement is Modified United State Public Health Service Criteria (Modified USPHS) using Binary (yes/ no) yes outcome mean recurrent caries present, no mean no recurrent caries present .
Measured: 12 months
Secondary outcomes (1)
clinical performance (Fracture and retention, marginal integrity, marginal discoloration, anatomic form, surface texture, postoperative sensitivity)
method of measurement is Modified United State Public Health Service Criteria (Modified USPHS) using (Alpha ,Bravo, Charlie) as unite of measurement by scoring %.
Alpha is best outcome and Charlie worse outcome.
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 posted17 Dec 2024
- Study start1 Oct 2024
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Class V 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
- Model description
- parallel assignment
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yehia Hafez Yehia, Cairo University
- Investigators
- Ashraf Nasr, professor, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06736964
- Sponsor's protocol ID
- Ahmed abdul monsif
- Status last verified
- Dec 2024
- First submitted
- 25 Nov 2024
- Last updated
- 17 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: all collected IPD will be shared with supervisor: dr.Ashraf Nasr , Dr. yahia Hafez
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Different Bioactive Restorative Materials for Cervical Carious in High Caries Risk Patients :A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06736964
- Acronym / sponsor ID
- Ahmed abdul monsif
- Conditions
- Class V Dental Caries, High Caries Risk Patients
- Keywords
- bioactive restorative material, dual cure bulk fill bio-active restoration, Pre-reacted glass ionomer (PRG) Giomer
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 17 Dec 2024 (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 the study is to clinically evaluate three different bioactive restorative material in cervical carious lesion in high caries risk patients.
Reducing the incidence of recurrent caries is the primary outcome
Detailed description
Bioactive restorative materials are relatively new concept in dentistry combines between esthetics, strength and resilience of composites with bioactive properties, the development of therapeutic bio-interactive materials results in tissue re-mineralization, reduces the susceptibility to tooth mineral loss, and recovers its mechanical properties .
Patients, with high caries, have many risk factors like inadequate biofilm control, salivary flow deficiency, and altered host defense. Conventional restorative materials expose the tooth structure to stress concentration. Moreover, preserving the tooth restoration interface intact is great challenge to avoid recurrent caries, which may also result in restoration failures .
This prospective study will be investigating and comparing the eighteen month clinical performance of a different bioactive restorative materials and a conventional Pre-reacted glass ionomer restorative material in class V cavity preparation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- parallel assignment
| Arm | Type | Receives |
|---|---|---|
| Predicta | Experimental | Device: Giomerbased on dual cure bulk fill bioactive restoration |
| Activa presto | Experimental | Device: Giomerbased on Bio-glass reinforced glass Ionomer |
| Giomer | Active comparator | Device: Giomerbased on Pre-reacted glass ionomer (PRG) |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patient age range from 25-45 year.
- High risk caries.
- Patients required at least a couple of Class V restorations.
- The depth of lesion should be(1.5- 2 mm) .
- The patient should have good general health
Key exclusion criteria (6 listed)
- Poor oral hygiene.
- Sever or chronic periodontal disease or Bruxism.
- Severe tooth sensitivity.
- Non-vital or fracture or cracked teeth.
- Defective restorations, orthodontic treatment or bleaching procedures during the last 6 months.
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 |
|---|---|---|
| Giomerbased on Pre-reacted glass ionomer (PRG) | Device | Activa presto, Giomer, Predicta |
Primary outcome
clinical performance (Post operative hyper sensitivity)
Time frame: 12 months
method of measurement is Modified United State Public Health Service Criteria (Modified USPHS) using Binary (yes/ no) yes outcome mean recurrent caries present, no mean no recurrent caries present .
1 secondary outcome
clinical performance (Fracture and retention, marginal integrity, marginal discoloration, anatomic form, surface texture, postoperative sensitivity)
Time frame: 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2024.
- Individual participant dataSharing planned: No. all collected IPD will be shared with supervisor: dr.Ashraf Nasr , Dr. yahia Hafez
Related trials for Class V Dental Caries
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Two Year Clinical Performance of Ion-releasing and Non Ion-releasing Composite Restorative Systems in Restoring Cervical Carious Lesions.
Class V Dental Caries
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Zirconia-Reinforced Glass Ionomer Versus Injectable Giomer in Class V Restorations
Class V Dental Caries, Type 2 Diabetes Mellitus, Giomer Technology; Injectable Resin Composite; Zirconia-Modified Glass Ionomer
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Self-Cure vs. Highly Filled Flowable Composite in Carious Cervical Lesions: 18-Month RCT
Carious Cervical Lesions
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Clinical Performance of Giomer-Based Composite Restorations in Class V Carious Lesions in Diabetic and Non-Diabetic Patients
Diabetes Mellitus
Active, not recruiting
Comparative Evaluation of Class V Restorations
Secondary Caries, Dental Restoration Failure of Marginal Integrity
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.
Ashraf Nasr, professor study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Giomer in people with Class V Dental Caries and High Caries Risk Patients, 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 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: enrolling by invitation, as of the sponsor's last update on 17 Dec 2024. 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?
This study is still under way. Results are not available in the source record yet.
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 (Post operative hyper sensitivity) (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 17 Dec 2024.