Dental Restoration FailureNCT05556551
Comparing Between Two Different Restoration
A study testing Full Ceramic restoration and Hybrid resin Ceramic restoration in people with Dental Restoration Failure, run by Mansoura University at 1 site in Egypt.
Trial summary
Clinical performance of two different ceramic restoration in patient mouth after 3 years follow up Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Dental Restoration Failure
- What is being tested?
- Full Ceramic restoration and Hybrid resin Ceramic restoration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 20 May 2019to 20 Jul 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- good oral hygiene
Who cannot join
- bad oral hygiene
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Performance of Lithium Disilicate Versus Hybrid Resin Ceramic for Inlay and Onlay Restoration After 3 Years Follow up
Clinical performance of two different ceramic restoration in patient mouth after 3 years follow up
Read the detailed description
Comparing two different dental restoration in patient mouth after 3 years follow up by using USPHS criteria
- Conditions
- Dental Restoration Failure
- Being tested
- Full Ceramic restoration, Hybrid resin Ceramic restoration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Full Ceramic restorationOther
Two different dental restoration inserted in patient mouth ( split mouth)
Hybrid resin Ceramic restorationOther
Hybrid resin Ceramic restoration
| Study group | Role | What they receive |
|---|---|---|
| Hybrid resin ceramic restoration | Other | Dental restoration Receives: Other: Hybrid resin Ceramic restoration |
| Full ceramic restoration | Other | Dental restoration Receives: Other: Full Ceramic restoration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of two different restoration
Using (USPHS) criteria
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2022
- Study start20 May 2019
- Primary completion20 Jul 2022
- Study completion20 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Model description
- Two different restorations in patient mouth
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05556551
- Sponsor's protocol ID
- 7755100
- Status last verified
- Sep 2019
- First submitted
- 5 Sep 2022
- Last updated
- 27 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Evaluation of two different restoration after 3 years follow up
Publications
Rubinstein MH. A new granulation method for compressed tablets [proceedings]. J Pharm Pharmacol. 1976 Dec;28 Suppl:67P. No abstract available.
PubMed 12345
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of Lithium Disilicate Versus Hybrid Resin Ceramic for Inlay and Onlay Restoration After 3 Years Follow up
- ClinicalTrials.gov ID
- NCT05556551
- Acronym / sponsor ID
- 7755100
- Conditions
- Dental Restoration Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 20 May 2019 (actual)
- Primary completion
- 20 Jul 2022 (actual)
- Study completion
- 20 Jul 2022 (actual)
- First posted
- 27 Sep 2022 (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.
Clinical performance of two different ceramic restoration in patient mouth after 3 years follow up
Detailed description
Comparing two different dental restoration in patient mouth after 3 years follow up by using USPHS criteria
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Two different restorations in patient mouth
| Arm | Type | Receives |
|---|---|---|
| Hybrid resin ceramic restoration | Other | Other: Hybrid resin Ceramic restorationDental restoration |
| Full ceramic restoration | Other | Other: Full Ceramic restorationDental restoration |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- good oral hygiene
Key exclusion criteria (1 listed)
- bad oral hygiene
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 |
|---|---|---|
| Full Ceramic restorationTwo different dental restoration inserted in patient mouth ( split mouth) | Other | Full ceramic restoration |
| Hybrid resin Ceramic restorationHybrid resin Ceramic restoration | Other | Hybrid resin ceramic restoration |
Primary outcome
Evaluation of two different restoration
Time frame: 3 years
Using (USPHS) 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 27 Sep 2022.
- Background: PubMed 12345Rubinstein MH. A new granulation method for compressed tablets [proceedings]. J Pharm Pharmacol. 1976 Dec;28 Suppl:67P. No abstract available.
- Individual participant dataSharing planned: No. Evaluation of two different restoration after 3 years follow up
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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 study testing Full Ceramic restoration and Hybrid resin Ceramic restoration in people with Dental Restoration Failure, run by Mansoura 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 1 inclusion and 1 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 27 Sep 2022. 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 two different restoration (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05556551, which also lists 1 linked publication.
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 27 Sep 2022.