Survival, ProsthesisNCT03523364
Survival Rate of All Ceramic Restorations Treated With Air-Water-Blasting Protocol
An observational study of Survival, Prosthesis, run by Università degli Studi 'G. d'Annunzio' Chieti e Pescara at 1 site in Italy.
Trial summary
This study evaluates retrospectively the survival rate of all-ceramic restorations, cemented using AWB technique (test) compared to those cemented with conventional technique (control) Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Survival, Prosthesis
- What is being tested?
- dental restorations
- Type of treatment
- Medical device
- How many people
- 131 participants
- Where
- 1 siteItaly
- Study dates
- 5 Jan 2017to 20 Feb 2018
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: all patients treated for bonded all-ceramic restorations between years 2003-2014
Who may be able to join
- patients who received at least one ceramic restoration
Who cannot join
- patients who received feldspathic ceramic restorations
Trial locations and contacts
1 site in 1 country.
Italy1 site
Dipartimento di Scienze Mediche Orali e Biotecnologiche
Chieti, CH, 66100
About this study
Official title: Long -Term Survival Rate of All Ceramic Restorations Cemented With Air-Water-Blasting Treatment Compared to Control Treatment
This study evaluates retrospectively the survival rate of all-ceramic restorations, cemented using AWB technique (test) compared to those cemented with conventional technique (control)
Read the detailed description
A retrospective study on ceramic restorations, placed in the period 2003-2014, will be performed to assess the survival rate of all-ceramic restorations cemented adhesively. The effectiveness of cementation largely depend on the method used. The Air-Water-blasting performed prior to conventional acid-etch of dental tissues offers an increase in bond strength compared to the conventional etching technique.
- Conditions
- Survival, Prosthesis
- Being tested
- dental restorations
- Medical subject headings
- Prosthesis Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dental restorationsDevice
partial or complete ceramic restorations bonded to dental tissues after WAB and total etching or after total etching
What is being measured
The primary outcome is the main question the study is designed to answer.
survival rate
integrity of the restorations
Measured: 2003-2014
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2018
- Study start5 Jan 2017
- Primary completion29 Jan 2018
- Study completion20 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Survival, ProsthesisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università degli Studi 'G. d'Annunzio' Chieti e Pescara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Traini Tonino, Università degli Studi 'G. d'Annunzio' Chieti e Pescara
- Investigators
- Tonino Traini, DDS; PhD, Principal investigator, University of Chieti-Pescara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03523364
- Sponsor's protocol ID
- 84183
- Status last verified
- May 2018
- First submitted
- 1 May 2018
- Last updated
- 14 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
van den Breemer CR, Vinkenborg C, van Pelt H, Edelhoff D, Cune MS. The Clinical Performance of Monolithic Lithium Disilicate Posterior Restorations After 5, 10, and 15 Years: A Retrospective Case Series. Int J Prosthodont. 2017 Jan/Feb;30(1):62-65. doi: 10.11607/ijp.4997.
PubMed 28085983Beier US, Kapferer I, Dumfahrt H. Clinical long-term evaluation and failure characteristics of 1,335 all-ceramic restorations. Int J Prosthodont. 2012 Jan-Feb;25(1):70-8.
PubMed 22259801
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long -Term Survival Rate of All Ceramic Restorations Cemented With Air-Water-Blasting Treatment Compared to Control Treatment
- ClinicalTrials.gov ID
- NCT03523364
- Acronym / sponsor ID
- 84183
- Conditions
- Survival, Prosthesis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Università degli Studi 'G. d'Annunzio' Chieti e PescaraUniversity, hospital or other
- Study start
- 5 Jan 2017 (actual)
- Primary completion
- 29 Jan 2018 (actual)
- Study completion
- 20 Feb 2018 (actual)
- First posted
- 14 May 2018 (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.
This study evaluates retrospectively the survival rate of all-ceramic restorations, cemented using AWB technique (test) compared to those cemented with conventional technique (control)
Detailed description
A retrospective study on ceramic restorations, placed in the period 2003-2014, will be performed to assess the survival rate of all-ceramic restorations cemented adhesively. The effectiveness of cementation largely depend on the method used. The Air-Water-blasting performed prior to conventional acid-etch of dental tissues offers an increase in bond strength compared to the conventional etching technique.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- all patients treated for bonded all-ceramic restorations between years 2003-2014
Key inclusion criteria (1 listed)
- patients who received at least one ceramic restoration
Key exclusion criteria (1 listed)
- patients who received feldspathic ceramic restorations
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 |
|---|---|---|
| dental restorationspartial or complete ceramic restorations bonded to dental tissues after WAB and total etching or after total etching | Device | – |
Primary outcome
survival rate
Time frame: 2003-2014
integrity of the restorations
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 14 May 2018.
- Background: PubMed 28085983van den Breemer CR, Vinkenborg C, van Pelt H, Edelhoff D, Cune MS. The Clinical Performance of Monolithic Lithium Disilicate Posterior Restorations After 5, 10, and 15 Years: A Retrospective Case Series. Int J Prosthodont. 2017 Jan/Feb;30(1):62-65. doi: 10.11607/ijp.4997.
- Background: PubMed 22259801Beier US, Kapferer I, Dumfahrt H. Clinical long-term evaluation and failure characteristics of 1,335 all-ceramic restorations. Int J Prosthodont. 2012 Jan-Feb;25(1):70-8.
- Individual participant dataSharing planned: Undecided
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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.
Tonino Traini, DDS; PhD principal investigator
University of Chieti-Pescara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Survival, Prosthesis, run by Università degli Studi 'G. d'Annunzio' Chieti e Pescara at 1 site in Italy.
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 14 May 2018. 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 Italy. 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?
survival rate (time frame: 2003-2014). 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 NCT03523364, which also lists 2 linked publications.
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 14 May 2018.