Back to resultsDAMP1: The 1T1T Concept Versus Conventional Implant Loading Protocol
Primary Purpose
Dental Implant Failure, Dental Prosthesis Failure
Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
The 1T1T concept versus conventional implant loading protocol
Sponsored by
About this trial
This is an interventional treatment trial for Dental Implant Failure focused on measuring CAD-CAM system, Immediate dental implant loading, PICN, Comparative study
Eligibility Criteria
Inclusion Criteria:
- 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%
- 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.
Exclusion Criteria:
- 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
- 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.
Sites / Locations
- Institute of Dentistry University of LiegeRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
DAMP1 :
Arm Description
Single arm trial comparing a conventional technique with an experimental one, within the same patient.
Outcomes
Primary Outcome Measures
Prostheses survival/success rates following international standards
Implants survival/success rates following international standards
Patient reported outcome measures (PROMs)
Questionnaires will be used to assess outcome measure
Time of protocols
Cost of protocols
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04045574
Brief Title
DAMP1: The 1T1T Concept Versus Conventional Implant Loading Protocol
Official Title
DAMP1: The 1T1T Concept Versus Conventional Implant Loading Protocol: A Comparative Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Recruiting
Study Start Date
September 2019 (Anticipated)
Primary Completion Date
September 2020 (Anticipated)
Study Completion Date
September 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Liege
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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). 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Implant Failure, Dental Prosthesis Failure
Keywords
CAD-CAM system, Immediate dental implant loading, PICN, Comparative study
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
single center comparative controlled trials
Masking
None (Open Label)
Masking Description
the technique to be used for each site will be randomized
Allocation
N/A
Enrollment
28 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
DAMP1 :
Arm Type
Experimental
Arm Description
Single arm trial comparing a conventional technique with an experimental one, within the same patient.
Intervention Type
Procedure
Intervention Name(s)
The 1T1T concept versus conventional implant loading protocol
Intervention Description
Implant placement followed by either a conventional or a delayed loading of a PICN screw-retained crown.
Primary Outcome Measure Information:
Title
Prostheses survival/success rates following international standards
Time Frame
up to 5 years
Title
Implants survival/success rates following international standards
Time Frame
up to 5 years
Title
Patient reported outcome measures (PROMs)
Description
Questionnaires will be used to assess outcome measure
Time Frame
up to 5 years
Title
Time of protocols
Time Frame
up to 2 months
Title
Cost of protocols
Time Frame
up to 2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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%
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.
Exclusion Criteria:
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
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amélie Mainjot, DDS, MSc, PhD
Phone
+32 496 95 30 30
Email
a.mainjot@chu.ulg.ac.be
First Name & Middle Initial & Last Name or Official Title & Degree
Anoushka Davarpanah, DDS
Phone
+33 6 26 76 47 11
Facility Information:
Facility Name
Institute of Dentistry University of Liege
City
Liege
State/Province
Choose A State
ZIP/Postal Code
4020
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amélie Mainjot, DDS, MSc, PhD
Phone
+32 496 95 30 30
Email
Amelie.Mainjot@uliege.be
First Name & Middle Initial & Last Name & Degree
Anoushka Davarpanah, DDS
Phone
+33 6 26 76 47 11
Email
anoushkadavarpanah@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
DAMP1: The 1T1T Concept Versus Conventional Implant Loading Protocol
We'll reach out to this number within 24 hrs