DAMP1: The 1T1T Concept Versus Conventional Implant Loading Protocol

NCT04045574 | Unknown

• 1 other identifier: DA001
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Implant Failure; Dental Prosthesis Failure

Keywords

CAD-CAM system; Immediate dental implant loading; PICN; Comparative study

Outcome Measures

Primary Outcomes (5)

• Prostheses survival/success rates following international standards

  up to 5 years

• Implants survival/success rates following international standards

  up to 5 years

• Patient reported outcome measures (PROMs)

  Questionnaires will be used to assess outcome measure

  up to 5 years

• Time of protocols

  up to 2 months

• Cost of protocols

  up to 2 months

Study Arms (1)

DAMP1 :

EXPERIMENTAL

Single arm trial comparing a conventional technique with an experimental one, within the same patient.

Procedure: The 1T1T concept versus conventional implant loading protocol

Interventions

The 1T1T concept versus conventional implant loading protocol PROCEDURE

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

DAMP1 :

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Liege: lead

Study Sites (1)

Institute of Dentistry University of Liege

Liège, Choose A State, 4020, Belgium

RECRUITING

Central Study Contacts

Amélie Mainjot, DDS, MSc, PhD

CONTACT

+32 496 95 30 30; a.mainjot@chu.ulg.ac.be

Anoushka Davarpanah, DDS

CONTACT

+33 6 26 76 47 11

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: the technique to be used for each site will be randomized
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: single center comparative controlled trials

Study Record Dates

• First Submitted: July 31, 2019
• First Posted: August 5, 2019
• Study Start: September 1, 2019
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2024
• Last Updated: August 6, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)