Clinical Evaluation of Two Different Attachment System (ADLCvsLOC)

University of Zurich (UZH)

Status: Invitation-only

Conditions: Dental Implant

Treatments: Device: ADLC attachment system with PEEK inserts

Study type: Interventional

Funder types: Other

Identifiers

NCT04544839

MCES/EC/613/2020

Details and patient eligibility

About

Edentulous patients commonly experience a deterioration in the quality of life; both in terms of oral and general health. Studies demonstrated that conventional dentures do not adequately restore masticatory function nor quality of life. In contrast, implant-supported overdentures are considered the standard of care for edentulous patients as they offer a more stable prosthesis that ultimately results in improved oral function and patient satisfaction.

Precision attachments such as studs, magnets, telescopic crowns or a bars are commonly used for implant supported overdentures. Implant overdentures supported by stud attachments gained popularity for the rehabilitation of edentulous patients as they are self-aligning, offer dual retention and compensate for divergence between implants up to angles of 40 degrees.

However, it has been documented that the stud attachment system (Locators) requires a high frequency of maintenance, particularly with regard to the replacement of the matrix.

In order to overcome some of these limitations of existing attachment systems, a newer system was developed consisting of a matrix made of polyetheretherketone (PEEK) instead of a polymeric material. This system has an amorphous diamond like carbon-based abutment coating (ADLC) and it was claimed to be more resistant to wear.

Clinically and in vitro, no comparative studies have been performed addressing wear and retention of the traditional stud attachment and the newer ADLC attachment.

Thus, the aim of the present study is to clinically and in vitro evaluate the ADLC and study attachment system.

Enrollment: 26 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Fully edentulous patients encountering problems (functional, aesthetics) with existing dentures in the upper and lower jaw or patients seeking for implant-supported prostheses
• Adequate bone in the anterior mandible for the placement of implants (Regular diameter implant with a minimal length of 10mm) in the canine region
• Written informed consent
• Ability to understand the procedure and to answer a questionnaire.

Exclusion criteria

• Impaired cognitive function and/or manual dexterity

• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant

• Unable to attend follow-up examinations

• Known or suspected non-compliance, drug or alcohol abuse

• Presence of any uncontrolled systematic disease that could compromise implant surgery and implant long-term performance

• History of radiotherapy in the head and neck region

• Heavy smoker (>10 cig. /day

• Any potential allergies or hypersensitivity to chemical ingredients of material used

  • Bruxism
  • Presence of bone metabolic disorders (e.g. osteoporosis)
  • Pregnant or lactating women

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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26 participants in 2 patient groups

ADLC attachment in first phase

Experimental group

Description:

Each patient will receive 2 implants in the canine region. Three months later, each patient will be randomized and half of the patients will receive first the ADLC (test) device (first phase). In the second phase of the crossover trial (6 months after the start of the first phase), the attachments will be replaced. Patients previously allocated to the ADLC group will receive the LOC attachments.

Treatment:

Device: ADLC attachment system with PEEK inserts

LOC attachment in first phase

Active Comparator group

Description:

Each patient will receive 2 implants in the canine region. Three months later, each patient will be randomized and half of the patients will receive first the LOC (control) device (first phase). In the second phase of the crossover trial (6 months after the start of the first phase), the attachments will be replaced. Patients previously allocated to the LOC group will receive the ADLC attachments.

Treatment:

Device: ADLC attachment system with PEEK inserts