Dental Restoration FailureNCT06603116
Evaluation of the Clinical Performance of Bioactive Giomer Restoration in Class II Cavities After One Year
A study testing treatment of class two cavities in people with Dental Restoration Failure, run by Faculty of Dental Medicine for Girls at 1 site in Egypt.
Trial summary
Assess the clinical performance of the bioactive Giomer restoration in class II cavities after one year using FDI criteria for assessment of dental restorations. Moreover, the surface roughness will be investigated in-vitro using profilometer Read more about this study
- Who is it for?
- Ages 20 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Restoration Failure
- What is being tested?
- treatment of class two cavities
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Nov 2022to 25 Mar 2024
- 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 20 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- • Each patient should have at least two proximal carious lesions on both sides in the posterior teeth.
- Adjacent and opposing natural teeth should be present.
- Patient should be willing to return for follow-up examination and evaluation.
Who cannot join
- • Patient with poor oral hygiene and motivation.
- Patient with unrealistic expectations.
- Patients with disabilities, systemic diseases or severe medically compromised, bruxism, clenching or temporomandibular joint disorders and patients with allergy to any components of the materials.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dental Medicine for Girls, Al-Azhar University, Egypt
Cairo
About this study
Official title: Evaluation of the Clinical Performance of Bioactive Giomer Restoration in Class II Cavities After One Year and in Vitro Investigation of the Surface Roughness
Assess the clinical performance of the bioactive Giomer restoration in class II cavities after one year using FDI criteria for assessment of dental restorations. Moreover, the surface roughness will be investigated in-vitro using profilometer
Read the detailed description
- Patients will be selected according to the following inclusion and exclusion criteria from the outpatient Operative clinic, Faculty of Dental Medicine for Girls, Al-Azhar University.
- The patients will be informed about the purpose of the investigation, the clinical procedures and the advantages/risks of the applied materials and techniques. A written informed consent form will be signed from patients prior to study initiation.
- Co-operative patients of age range 20-30 years old with no gender prediction, The patients will be divided into two groups Group (1): Bioactive Giomer restoration. Group (2): Nano-hybrid Composite restoration. Restoration will be evaluated using FDI criteria (functional and biological properties) All the restorations will be clinically evaluated after 1 week (baseline),3 month, 6 months,12 months. data collected and statistically analyzed
- Conditions
- Dental Restoration Failure
- Being tested
- treatment of class two cavities
- Keywords
- Bioactive Giomer restoration, Nano hybrid composite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
treatment of class two cavitiesOther
restorations in class 2 cavities
| Study group | Role | What they receive |
|---|---|---|
| Bioactive Giomer restoration. | Experimental | material applied according to manufacturer instructions. BEAUTIFIL II LS applied directly into the cavity and create the shape desired in layers not exceeding 2 mm and light cured for 20 seconds Receives: Other: treatment of class two cavities |
| Nano-hybrid Composite restoration. | Active comparator | applied to the cavity use the conventional incremental technique according to manufacturer instruction Receives: Other: treatment of class two cavities |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluation of restorations of class two cavities
Measured used FDI criteria
Measured: from one week to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start15 Nov 2022
- Primary completion22 Nov 2022
- Study completion25 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Restoration FailureStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculty of Dental Medicine for Girls
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Noha Taher, Faculty of Dental Medicine for Girls
- Investigators
- Maha Niazy, PHD, Study director, Faculty of Dental Medicine for Girls, Al-Azhar University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06603116
- Sponsor's protocol ID
- NTaher
- Status last verified
- Sep 2024
- First submitted
- 17 Sep 2024
- Last updated
- 19 Sep 2024
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Clinical Performance of Bioactive Giomer Restoration in Class II Cavities After One Year and in Vitro Investigation of the Surface Roughness
- ClinicalTrials.gov ID
- NCT06603116
- Acronym / sponsor ID
- NTaher
- Conditions
- Dental Restoration Failure
- Keywords
- Bioactive Giomer restoration, Nano hybrid composite
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Faculty of Dental Medicine for GirlsOther government
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 22 Nov 2022 (actual)
- Study completion
- 25 Mar 2024 (actual)
- First posted
- 19 Sep 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.
Assess the clinical performance of the bioactive Giomer restoration in class II cavities after one year using FDI criteria for assessment of dental restorations. Moreover, the surface roughness will be investigated in-vitro using profilometer
Detailed description
- Patients will be selected according to the following inclusion and exclusion criteria from the outpatient Operative clinic, Faculty of Dental Medicine for Girls, Al-Azhar University.
- The patients will be informed about the purpose of the investigation, the clinical procedures and the advantages/risks of the applied materials and techniques. A written informed consent form will be signed from patients prior to study initiation.
- Co-operative patients of age range 20-30 years old with no gender prediction, The patients will be divided into two groups Group (1): Bioactive Giomer restoration. Group (2): Nano-hybrid Composite restoration. Restoration will be evaluated using FDI criteria (functional and biological properties) All the restorations will be clinically evaluated after 1 week (baseline),3 month, 6 months,12 months. data collected and statistically analyzed
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bioactive Giomer restoration. | Experimental | Other: treatment of class two cavitiesmaterial applied according to manufacturer instructions. BEAUTIFIL II LS applied directly into the cavity and create the shape desired in layers not exceeding 2 mm and light cured for 20 seconds |
| Nano-hybrid Composite restoration. | Active comparator | Other: treatment of class two cavitiesapplied to the cavity use the conventional incremental technique according to manufacturer instruction |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- • Each patient should have at least two proximal carious lesions on both sides in the posterior teeth.
Key exclusion criteria (3 listed)
- • Patient with poor oral hygiene and motivation.
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 |
|---|---|---|
| treatment of class two cavitiesrestorations in class 2 cavities | Other | Bioactive Giomer restoration., Nano-hybrid Composite restoration. |
Primary outcome
evaluation of restorations of class two cavities
Time frame: from one week to one year
Measured used 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 19 Sep 2024.
- 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.
Maha Niazy, PHD study director
Faculty of Dental Medicine for Girls, Al-Azhar University, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing treatment of class two cavities in people with Dental Restoration Failure, run by Faculty of Dental Medicine for Girls 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 3 inclusion and 3 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 19 Sep 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?
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?
evaluation of restorations of class two cavities (time frame: from one week to one 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 19 Sep 2024.