Dental Restoration FailurePhase 1NCT04701320
Clinical Evaluation of Nano Hydroxyapatite Reinforced Glass Ionomer in Treatment of Root Caries in Geriatric Patients
A Phase 1 study testing Conventional glass ionomer and Nano hydroxyapatite reinforced glass ionomer in people with Dental Restoration Failure, run by Cairo University at 1 site in Egypt.
Trial summary
In geriatric patients, will the clinical performance of nano hydroxyapatite reinforced glass ionomer be better than conventional glass ionomer cement in treatment of root caries lesions over one year follow up? Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Restoration Failure
- What is being tested?
- Conventional glass ionomer and Nano hydroxyapatite reinforced glass ionomer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 7 Jul 2019to 9 Aug 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- • ≥ 50 years old
- Males or females.
- Community-dwelling
- Have five or more of their own teeth
- With ≥ 1 root caries lesion
Who cannot join
- • Patients younger than 50 years old
- Disabilities.
- Systemic diseases or severe medically compromised.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of Nano Hydroxyapatite Reinforced Glass Ionomer Versus Conventional Glass Ionomer in Treatment of Root Caries in Geriatric Patients: A Randomized Controlled Clinical Trial
In geriatric patients, will the clinical performance of nano hydroxyapatite reinforced glass ionomer be better than conventional glass ionomer cement in treatment of root caries lesions over one year follow up?
Read the detailed description
Glass carbomers are commercialized under the name of GCP Glass Fill, this material may be an interesting subject of research, certainly its bioactive properties as the manufacturer claims this material to have remineralizing properties. If this is the case, GCP Glass Fill could be an interesting reference material for further bioactivity studies
- Conditions
- Dental Restoration Failure
- Being tested
- Conventional glass ionomer, Nano hydroxyapatite reinforced glass ionomer
- Keywords
- Glass Carbomer GCP glass fill root caries Clinical perfomance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional glass ionomerDrug
Also called Fujiix gc corporation
Conventional glass ionomer with enhanced mechanical and esthetic proberties
Nano hydroxyapatite reinforced glass ionomerDrug
Also called Glass carbomer
Nanohydroxyapatite reinforced glass ionomer restorative material with enhanced mechanical proberties and chemical adhesion to tooth structure
| Study group | Role | What they receive |
|---|---|---|
| Glass carbomer | Experimental | Nano hydroxyapatite Reinforced Glass Ionomer that results in chemical bond formation with tooth structure mimic that of enamel tissue Receives: Drug: Nano hydroxyapatite reinforced glass ionomer |
| Fuji ix | Active comparator | Conventional Glass Ionomer cement fluoride-releasing restorative system that combines fluoride release of glass ionomer cement and acceptable esthetics, a wear resistant, self-adhesive Receives: Drug: Conventional glass ionomer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical restorative performance Service (USHPS)
Change in the clinical behavior of the restoration (e.g. anatomical contour, shade match, secondary caries) using modified United State Public Health clinical evaluation assessment method Service (USHPS)
Measured: Change from the baseline at 3, 6 and12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2021
- Study start7 Jul 2019
- Primary completion7 Jul 2019
- Study completion9 Aug 2021 (estimated)
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.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reham nabil mahmoud, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04701320
- Sponsor's protocol ID
- OPER 3-3-6
- Status last verified
- Jan 2021
- First submitted
- 25 Jul 2020
- Last updated
- 8 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Nano Hydroxyapatite Reinforced Glass Ionomer Versus Conventional Glass Ionomer in Treatment of Root Caries in Geriatric Patients: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04701320
- Acronym / sponsor ID
- OPER 3-3-6
- Conditions
- Dental Restoration Failure
- Keywords
- Glass Carbomer GCP glass fill root caries Clinical perfomance
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 7 Jul 2019 (actual)
- Primary completion
- 7 Jul 2019 (actual)
- Study completion
- 9 Aug 2021 (estimated)
- First posted
- 8 Jan 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.
In geriatric patients, will the clinical performance of nano hydroxyapatite reinforced glass ionomer be better than conventional glass ionomer cement in treatment of root caries lesions over one year follow up?
Detailed description
Glass carbomers are commercialized under the name of GCP Glass Fill, this material may be an interesting subject of research, certainly its bioactive properties as the manufacturer claims this material to have remineralizing properties. If this is the case, GCP Glass Fill could be an interesting reference material for further bioactivity studies
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glass carbomer | Experimental | Drug: Nano hydroxyapatite reinforced glass ionomerNano hydroxyapatite Reinforced Glass Ionomer that results in chemical bond formation with tooth structure mimic that of enamel tissue |
| Fuji ix | Active comparator | Drug: Conventional glass ionomerConventional Glass Ionomer cement fluoride-releasing restorative system that combines fluoride release of glass ionomer cement and acceptable esthetics, a wear resistant, self-adhesive |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- • ≥ 50 years old
Key exclusion criteria (3 listed)
- • Patients younger than 50 years old
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 glass ionomerAlso: Fujiix gc corporationConventional glass ionomer with enhanced mechanical and esthetic proberties | Drug | Fuji ix |
| Nano hydroxyapatite reinforced glass ionomerAlso: Glass carbomerNanohydroxyapatite reinforced glass ionomer restorative material with enhanced mechanical proberties and chemical adhesion to tooth structure | Drug | Glass carbomer |
Primary outcome
Clinical restorative performance Service (USHPS)
Time frame: Change from the baseline at 3, 6 and12 months
Change in the clinical behavior of the restoration (e.g. anatomical contour, shade match, secondary caries) using modified United State Public Health clinical evaluation assessment method Service (USHPS)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2021.
- Individual participant dataSharing planned: Yes
Related trials for Dental Restoration Failure
Not yet recruiting
The Effect of Decoupling With Time Technique on the Clinical Performance of Proximal Posterior Composite Restorations
Dental Restoration Failure, Postoperative Hypersensitivity
Active, not recruiting
A Split-Mouth Clinical Trial Evaluating the Bond Failure Rate of a New Etch-Free Orthodontic Adhesive
Bracket Bonding, Orthodontic Treatment
Active, not recruiting
Clinical Evaluation of Short Dentin Etching
Hypersensitivity Dentin, Dental Restoration Failure of Marginal Integrity
RecruitingObservational study
Clinical Performance and Failure Rates of Restorations Following Pediatric Dental Rehabilitation Under General Anesthesia
Pediatric Dental General Anesthesia, Restoration
Not yet recruiting
Repair Versus Replacement of Failed Restorations in Primary Teeth
Dental Caries, Restoration Defects
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 Conventional glass ionomer and Nano hydroxyapatite reinforced glass ionomer in people with Dental Restoration Failure, 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 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: status not confirmed, as of the sponsor's last update on 8 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?
Clinical restorative performance Service (USHPS) (time frame: Change from the baseline at 3, 6 and12 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 8 Jan 2021.