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DAMP1: The 1T1T Concept Versus Conventional Implant Loading Protocol

NCT04045574 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2019-08-06

No results posted yet for this study

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.

Conditions

  • Dental Implant Failure
  • Dental Prosthesis Failure

Interventions

PROCEDURE

The 1T1T concept versus conventional implant loading protocol

Implant placement followed by either a conventional or a delayed loading of a PICN screw-retained crown.

Sponsors & Collaborators

  • University of Liege

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-30
Primary Completion
2020-09-30
Completion
2024-09-30

Countries

  • Belgium

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04045574 on ClinicalTrials.gov