Minimally Invasive Treatment of Worn Dentition With Innovative CAD-CAM Composites

• Sponsor: University of Liege (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02828696
• Collaborator: (none)
• Enrollment: 14
• Location: 1
• Arm: 1
• Duration (Months): 66
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

This study evaluates the effectiveness of a minimally invasive treatment, consisting of partial polymer-infiltrated-ceramic-network (PICN) restorations, used in case of rehabilitation of advanced and generalized dental wear over a period of 5 years.

Condition or Disease	Intervention/Treatment	Phase
Tooth Wear	Device: "No prep" treatment of worn dentition with CAD-CAM composite	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 14 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Minimally Invasive Treatment of Worn Dentition With Innovative CAD-CAM Composites
• Study Start Date: Jun 1, 2016
• Anticipated Primary Completion Date: Jun 1, 2021
• Anticipated Study Completion Date: Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Other: No prep "No prep" treatment of worn dentition with CAD-CAM composite (PICN)	Device: "No prep" treatment of worn dentition with CAD-CAM composite; Realization of minimally invasive prostheses in PICN (CAD-CAM composite)for worn dentition. Tooth tissues are preserved: no preparation is performed and ultra-thin restorations are CAD-CAM milled.

Outcome Measures

Primary Outcome Measures

1. Clinical evaluation of minimally-invasive treatment protocol of worn dentition [5 years]

   Clinical evaluation following FDI criteria

2. Quality of life evaluation of minimally-invasive treatment protocol of worn dentition [5 years]

   Quality of life questionnaires

Secondary Outcome Measures

1. Toxicology evaluation of PICN restorations mechanical and biological behaviour [5 years]

   Toxicology ex vivo evaluation

2. Wear evaluation of PICN restorations mechanical and biological behaviour [5 years]

   Wear ex vivo evaluation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Patients presenting advanced and generalized worn dentition

• All the posterior teeth (minus 2) present wear

• All the anterior teeth (tooth n°13 to n°23) need palatal veneers

Exclusion Criteria:

• More than one missing tooth on each mandible

• Patients with crown(s), bridge(s) or implant(s)

• Patients with non-stabilized parodontite

• Smoker

• Patients suffering from :

1. Parkinson's Disease

2. Severe osteoarthritis

3. Spontaneous pain in the temporomandibular joints, shift of the mandible and an opening limit (25 mm)

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institute of Dentistry University of Liege	Liege		Belgium	4000

Sponsors and Collaborators

• University of Liege

Investigators

• Study Director: Amélie Mainjot, University Hospital Center (CHU) of Liège

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mainjot Amélie, Professor, University of Liege
• ClinicalTrials.gov Identifier: NCT02828696
• Other Study ID Numbers: NP001
• First Posted: Jul 12, 2016
• Last Update Posted: May 13, 2019
• Last Verified: May 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by Mainjot Amélie, Professor, University of Liege: CAD-CAM composites; Worn dentition; minimally invasive treatment
• Additional relevant MeSH terms: Tooth Wear

Study Results

No Results Posted as of May 13, 2019