Dental Implant Failed1T1TNCT02898311
One-Tooth One-Time (1T1T) A Straightforward Approach to Replace Missing Teeth in the Posterior Region: a Case Series
A study testing immediate loading of posterior implants with chairside CAD-CAM composite crown in people with Dental Implant Failed and Dental Prosthesis Failure, run by University of Liege at 2 sites in Belgium.
Trial summary
This study evaluates the success rate, as the biological and prosthesis complications, of posterior single-unit implants immediately loaded with a chair side Computer-Aided Design and Manufacturing (CAD-CAM) composite crown, after a follow-up period of 6 months,1,2,3,4 and 5 years. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dental Implant Failed, Dental Prosthesis Failure
- What is being tested?
- immediate loading of posterior implants with chairside CAD-CAM composite crown
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- 2 sitesBelgium
- Study dates
- Jul 2016to Sep 2021
- 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 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- 0 In good systemic health (ASA I/ II)
- Present with no contra indication against oral surgical interventions
- The tooth at the implant site(s) must have been extracted or lost at least 12 weeks before the date of implantation.
- At least 8 mm of bone in the vertical dimension
- At least 6 mm of bone in the bucco-lingual dimension.
- No need for bone augmentation procedure in any of the dimensions
- Full mouth plaque score (FMPI) lower or equal than 25%
Who cannot join
- Autoimmune disease requiring medical treatment
- Medical conditions requiring prolonged use of steroids
- Use of Bisphosphonate intravenously or more then ˃ 3 years of oral use
- Infection (local or systemic) - patient with gingivitis or active local infection will undergo a medical treatment prior to his entrance to the study, each individual will be evaluated prior to study procedure for suitability, in case of systemic infection the evaluation will be based on medical anamneses, and if necessary will be referred to relevant medical tests.
- Current pregnancy or breastfeeding women
- Alcoholism or chronically drug abuse
Show all 20Show fewer
- Immunocompromised patients
- Uncontrolled Diabetes
- Smokers
- Prisoners
- Conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance, or unreliability.
- Local exclusion criteria:
- Sites treated with socket preservation techniques
- Untreated local inflammation
- Mucosal diseases or oral lesions
- History of local irradiation therapy in Head-Neck area
- Persistent intraoral infection (periodontitis, caries, …)
- Patients inadequate oral hygiene or unmotivated for normal home care.
- Removable prosthesis as an antagonist of the teeth to be replaced or absence of antagonistic teeth
- Severe bruxism or parafunctions
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites, 2 recruiting
- Recruiting
Liege University Hospital Center of Liege
Liège, 4000
- Recruiting
University Hospital Center of Liège
Liège, 4000
About this study
This study evaluates the success rate, as the biological and prosthesis complications, of posterior single-unit implants immediately loaded with a chair side Computer-Aided Design and Manufacturing (CAD-CAM) composite crown, after a follow-up period of 6 months,1,2,3,4 and 5 years.
Complementary ex vivo analyses will be performed to evaluate the wear of restorations. The time and cost benefit of the presented digital workflow, as patient centered outcomes will also be evaluated.
- Conditions
- Dental Implant Failed, Dental Prosthesis Failure
- Being tested
- immediate loading of posterior implants with chairside CAD-CAM composite crown
- Keywords
- CAD-CAM, composite dental resin, Immediate dental implant loading
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immediate loading of posterior implants with chairside CAD-CAM composite crownDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant complication rate
Measured: 6 months
Prosthesis complication rate
Measured: 6 months
Secondary outcomes (3)
Evaluation of treatment duration, timing (in minutes) all the different steps of the surgical and prosthodontic procedure.
Measured: 1 day
Evaluation of patient satisfaction with VAS (visual analog scale) questionnaire
Measured: 1 day
Evaluation of patient satisfaction with VAS (visual analog scale) questionnaire
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2016 (estimated)
- Study startJul 2016
- Primary completionMay 2017
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Implant FailedStudies 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
- Not applicable
- Intervention model
- Single group
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mainjot Amélie, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02898311
- Sponsor's protocol ID
- TT001
- Acronym
- 1T1T
- Status last verified
- May 2019
- First submitted
- 27 Aug 2016
- Last updated
- 10 May 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One-Tooth One-Time (1T1T) A Straightforward Approach to Replace Missing Teeth in the Posterior Region: a Case Series
- ClinicalTrials.gov ID
- NCT02898311
- Acronym / sponsor ID
- 1T1T / TT001
- Conditions
- Dental Implant Failed, Dental Prosthesis Failure
- Keywords
- CAD-CAM, composite dental resin, Immediate dental implant loading
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- May 2017 (actual)
- Study completion
- Sep 2021 (estimated)
- First posted
- 13 Sep 2016 (estimated)
- 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 the success rate, as the biological and prosthesis complications, of posterior single-unit implants immediately loaded with a chair side Computer-Aided Design and Manufacturing (CAD-CAM) composite crown, after a follow-up period of 6 months,1,2,3,4 and 5 years.
Complementary ex vivo analyses will be performed to evaluate the wear of restorations. The time and cost benefit of the presented digital workflow, as patient centered outcomes will also be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 0 In good systemic health (ASA I/ II)
- Present with no contra indication against oral surgical interventions
- The tooth at the implant site(s) must have been extracted or lost at least 12 weeks before the date of implantation.
- At least 8 mm of bone in the vertical dimension
- At least 6 mm of bone in the bucco-lingual dimension.
Key exclusion criteria (20 listed)
- Autoimmune disease requiring medical treatment
- Medical conditions requiring prolonged use of steroids
- Use of Bisphosphonate intravenously or more then ˃ 3 years of oral use
- Infection (local or systemic) - patient with gingivitis or active local infection will undergo a medical treatment prior to his entrance to the study, each individual will be evaluated prior to study procedure for suitability, in case of systemic infection the evaluation will be based on medical anamneses, and if necessary will be referred to relevant medical tests.
- Current pregnancy or breastfeeding women
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 |
|---|---|---|
| immediate loading of posterior implants with chairside CAD-CAM composite crown | Device | – |
Primary outcome
Implant complication rate
Time frame: 6 months
Prosthesis complication rate
Time frame: 6 months
3 secondary outcomes
Evaluation of treatment duration, timing (in minutes) all the different steps of the surgical and prosthodontic procedure.
Time frame: 1 day
Evaluation of patient satisfaction with VAS (visual analog scale) questionnaire
Time frame: 1 day
Evaluation of patient satisfaction with VAS (visual analog scale) questionnaire
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2019.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing immediate loading of posterior implants with chairside CAD-CAM composite crown in people with Dental Implant Failed and Dental Prosthesis Failure, run by University of Liege at 2 sites in Belgium.
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 7 inclusion and 20 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 10 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amélie Mainjot (003242703131, a.mainjot@chu.ulg.ac.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant complication rate (time frame: 6 months). The study lists 2 primary outcomes in all. 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 10 May 2019.