Dental Implant FailureNCT04045574
DAMP1: The 1T1T Concept Versus Conventional Implant Loading Protocol
A study testing The 1T1T concept versus conventional implant loading protocol in people with Dental Implant Failure and Dental Prosthesis Failure, run by University of Liege at 1 site in Belgium.
Trial summary
The One tooth - One time (1T1T) innovative approach is a straightforward and cost-effective protocol to replace a missing tooth in the posterior region (Lambert and Mainjot 2017) (see Appendix). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dental Implant Failure, Dental Prosthesis Failure
- What is being tested?
- The 1T1T concept versus conventional implant loading protocol
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2019to Sep 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject must have voluntarily signed the informed consent form before any study related action
- Age : 18 or above
- Men/Women
- Patient in good systemic health (ASA I/ II)
- No contraindication against oral surgical interventions
- Full mouth plaque score (FMPI) lower or equal than 25%
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- Patient with two single unit edentulous space in the posterior area, upper or lower jaw, seeking for implant therapy
- Maximum two missing teeth per quadrant
- Two single unit edentulous spaces can be contiguous if there are three posterior teeth in occlusal contact in the tested half arch.
- After the crown placement, at least 3 posterior teeth must be in occlusal contact with the antagonistic teeth in the tested half arch.
- The tooth at the implant site 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.
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 11Show fewer
- Immunocompromised patients
- Uncontrolled Diabetes
- Smokers (more than 10 cigarettes/day)
- 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.
Trial locations and contacts
1 site in 1 country.
Anoushka Davarpanah, DDS contact
Belgium1 site, 1 recruiting
- Recruiting
Institute of Dentistry University of Liege
Liège, Choose A State, 4020
Amélie Mainjot, DDS, MSc, PhD, +32 496 95 30 30, Amelie.Mainjot@uliege.be
Anoushka Davarpanah, DDS, +33 6 26 76 47 11, anoushkadavarpanah@gmail.com
About this study
Official title: DAMP1: The 1T1T Concept Versus Conventional Implant Loading Protocol: A Comparative Study
The One tooth - One time (1T1T) innovative approach is a straightforward and cost-effective protocol to replace a missing tooth in the posterior region (Lambert and Mainjot 2017) (see Appendix). The digital impression of single unit implants right after the implant placement and the direct manufacturing of a Polymer-Infiltrated Ceramic Network (PICN) screw-retained crown allows the delivery of a final tooth in occlusion within the same day. The absence of lab procedures reduces the number of appointments, providing immediate results and high patient satisfaction. The prosthesis material choice is crucial in this procedure. Indeed, PICN high resilience, i.e. damping effect, could reduce peri-implant strain compared to ceramic materials (Magne, Silva et al. 2013) (Maminskas, Puisys et al. 2016), moreover its elastic modulus is close to tooth tissues, while other CAD-CAM composites value is too low and ceramic materials are too high. The rapid milling and manufacturing process, without any firing procedure, and the ease of adjustments (particularly to adjust proximal and occlusal contact points), make also PICNs well-adapted to chair-side systems. The material low stiffness and hardness can improve patient comfort and promote adaptation of the restorations to occlusal relationships with time. The 1T1T approach was presented as a proof of concept in a first international publication using tissue level implants from Straumann, which describes the whole protocol (Lambert and Mainjot 2017). Currently, a case series including 10 teeth is on-course, showing a 100% survival rate of implants and restorations after a 2-yr follow-up. These results are very promising but further clinical research is needed to validate such a protocol on a larger number of patients, on other implant systems as well as to compare this approach to conventional protocols.
Read the detailed description
The present study is designed as a single center comparative controlled trial. This study aims to compare immediate (1T1T) versus delayed loading with a final PICN screw-retained crown (DL-PICN), performed with CAD-CAM system. A total of 28 consecutive patients (56 teeth) above the age of 18 and presenting two single-unit edentulous space in the posterior region (molars or premolars, upper or lower jaw), will be considered for possible inclusion in the study, according to the inclusion and exclusion criteria (patients with high occlusal stress will be included).
The performance of the different protocols will be tested in terms of (1) prostheses and implants survival and success rates following international standards (2) Patient reported outcome measures (PROMs); (3) time and cost. Moreover, restorations and antagonistic teeth wear will be studied trough ex-vivo analysis by profilometry of replica. The evaluations will be carried out at a follow-up period of 7 days, 2, 6 months and then every year up to 5 years.
Hypothesis is that the type of loading technique with a final PICN crown (1T1T or DL-PICN) does not influence prostheses and implants survival and success rates, but that 1T1T protocol improves patient-centered outcomes as well as time and cost effectiveness in comparison with DL-PICN.
The overall cost of the restoration treatment will be 1600€ (instead of 2100€), which represents a saving of 500€ for the patient.
- Conditions
- Dental Implant Failure, Dental Prosthesis Failure
- Being tested
- The 1T1T concept versus conventional implant loading protocol
- Keywords
- CAD-CAM system, Immediate dental implant loading, PICN, Comparative study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The 1T1T concept versus conventional implant loading protocolProcedure or surgery
Implant placement followed by either a conventional or a delayed loading of a PICN screw-retained crown.
| Study group | Role | What they receive |
|---|---|---|
| DAMP1 : | Experimental | Single arm trial comparing a conventional technique with an experimental one, within the same patient. Receives: Procedure: The 1T1T concept versus conventional implant loading protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prostheses survival/success rates following international standards
Measured: up to 5 years
Implants survival/success rates following international standards
Measured: up to 5 years
Patient reported outcome measures (PROMs)
Questionnaires will be used to assess outcome measure
Measured: up to 5 years
Time of protocols
Measured: up to 2 months
Cost of protocols
Measured: up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2019
- Study startSep 2019 (estimated)
- Primary completionSep 2020 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Implant 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
- Not applicable
- Intervention model
- Single group
- Model description
- single center comparative controlled trials
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
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
- NCT04045574
- Sponsor's protocol ID
- DA001
- Status last verified
- Aug 2019
- First submitted
- 31 Jul 2019
- Last updated
- 6 Aug 2019
- 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 6 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DAMP1: The 1T1T Concept Versus Conventional Implant Loading Protocol: A Comparative Study
- ClinicalTrials.gov ID
- NCT04045574
- Acronym / sponsor ID
- DA001
- Conditions
- Dental Implant Failure, Dental Prosthesis Failure
- Keywords
- CAD-CAM system, Immediate dental implant loading, PICN, Comparative study
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- Sep 2019 (estimated)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 5 Aug 2019 (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.
The One tooth - One time (1T1T) innovative approach is a straightforward and cost-effective protocol to replace a missing tooth in the posterior region (Lambert and Mainjot 2017) (see Appendix). The digital impression of single unit implants right after the implant placement and the direct manufacturing of a Polymer-Infiltrated Ceramic Network (PICN) screw-retained crown allows the delivery of a final tooth in occlusion within the same day. The absence of lab procedures reduces the number of appointments, providing immediate results and high patient satisfaction. The prosthesis material choice is crucial in this procedure. Indeed, PICN high resilience, i.e. damping effect, could reduce peri-implant strain compared to ceramic materials (Magne, Silva et al. 2013) (Maminskas, Puisys et al. 2016), moreover its elastic modulus is close to tooth tissues, while other CAD-CAM composites value is too low and ceramic materials are too high. The rapid milling and manufacturing process, without any firing procedure, and the ease of adjustments (particularly to adjust proximal and occlusal contact points), make also PICNs well-adapted to chair-side systems. The material low stiffness and hardness can improve patient comfort and promote adaptation of the restorations to occlusal relationships with time. The 1T1T approach was presented as a proof of concept in a first international publication using tissue level implants from Straumann, which describes the whole protocol (Lambert and Mainjot 2017). Currently, a case series including 10 teeth is on-course, showing a 100% survival rate of implants and restorations after a 2-yr follow-up. These results are very promising but further clinical research is needed to validate such a protocol on a larger number of patients, on other implant systems as well as to compare this approach to conventional protocols.
Detailed description
The present study is designed as a single center comparative controlled trial. This study aims to compare immediate (1T1T) versus delayed loading with a final PICN screw-retained crown (DL-PICN), performed with CAD-CAM system. A total of 28 consecutive patients (56 teeth) above the age of 18 and presenting two single-unit edentulous space in the posterior region (molars or premolars, upper or lower jaw), will be considered for possible inclusion in the study, according to the inclusion and exclusion criteria (patients with high occlusal stress will be included).
The performance of the different protocols will be tested in terms of (1) prostheses and implants survival and success rates following international standards (2) Patient reported outcome measures (PROMs); (3) time and cost. Moreover, restorations and antagonistic teeth wear will be studied trough ex-vivo analysis by profilometry of replica. The evaluations will be carried out at a follow-up period of 7 days, 2, 6 months and then every year up to 5 years.
Hypothesis is that the type of loading technique with a final PICN crown (1T1T or DL-PICN) does not influence prostheses and implants survival and success rates, but that 1T1T protocol improves patient-centered outcomes as well as time and cost effectiveness in comparison with DL-PICN.
The overall cost of the restoration treatment will be 1600€ (instead of 2100€), which represents a saving of 500€ for the patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single center comparative controlled trials
| Arm | Type | Receives |
|---|---|---|
| DAMP1 : | Experimental | Procedure: The 1T1T concept versus conventional implant loading protocolSingle arm trial comparing a conventional technique with an experimental one, within the same patient. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Subject must have voluntarily signed the informed consent form before any study related action
- Age : 18 or above
- Men/Women
- Patient in good systemic health (ASA I/ II)
- No contraindication against oral surgical interventions
Key exclusion criteria (11 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 |
|---|---|---|
| The 1T1T concept versus conventional implant loading protocolImplant placement followed by either a conventional or a delayed loading of a PICN screw-retained crown. | Procedure or surgery | DAMP1 : |
Primary outcome
Prostheses survival/success rates following international standards
Time frame: up to 5 years
Implants survival/success rates following international standards
Time frame: up to 5 years
Patient reported outcome measures (PROMs)
Time frame: up to 5 years
Questionnaires will be used to assess outcome measure
Time of protocols
Time frame: up to 2 months
Cost of protocols
Time frame: up to 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2019.
- 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.
Anoushka Davarpanah, DDS contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The 1T1T concept versus conventional implant loading protocol in people with Dental Implant Failure and Dental Prosthesis Failure, run by University of Liege at 1 site 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 13 inclusion and 11 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 6 Aug 2019. 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 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, DDS, MSc, PhD (+32 496 95 30 30, 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?
Prostheses survival/success rates following international standards (time frame: up to 5 years). The study lists 5 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 6 Aug 2019.