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Enrolling by Invitation

NCT Number: NCT04544839

Clinical Evaluation of Two Different Attachment System

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.

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Key information

Conditions

Dental Implant

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

M.A.Rangoonwala College of Dental Sciences & Research Center

Pune, 411001, India

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ADLC attachment system with PEEK inserts

Device

Each patient will receive 2 implants in the canine region using a guided-surgery protocol and a pre-prepared surgical stent. A healing abutment of an adequate size will be placed on the implant for transmucosal healing. The flaps will be subsequently sutured around the healing abutments. Patients' existing prostheses will be adjusted. Suture removal will be performed one week post implant placement.

Three months later, implant level impressions will be made using the open tray technique. Each patient will be then be randomized using eCRF (electronic Case Report Form) to either ADLC group or LOC group. A final cast of the patients will be obtained and the attachments will be installed using an in-direct technique by a calibrated prosthodontists.

Other names: NOVALOC

Primary outcomes

  1. Patient reported outcome measure

    Time frame: After a functional period of 6 months

    Mean VAS scores (visual analogue scale (0-100)) related to patient overall satisfaction for the ADLC and the LOC (Locator) attachment system provided by the patients

Secondary outcomes

  1. Patient-Reported Outcome Measures (PROMs): VAS

    Time frame: 6 months, 1, 3, 5 years after the evaluation period of the second attachment systems

    VAS scores (visual analogue scale (0-100)) based questionnaires about retention, stability of the prosthesis, maintenance of oral hygiene, ability to speak, comfort and aesthetics will be evaluated at screening

  2. Patient-Reported Outcome Measures (PROMs): OHIP-14

    Time frame: 6 months, 1, 3, 5 years after the evaluation period of the second attachment systems

    OHIP-14 (Oral Health Impact Profile) will be evaluated at screening (Questionnaire)

  3. Patient-Reported Outcome Measures (PROMs): Costs

    Time frame: 6 months, 1, 3, 5 years after the evaluation period of the second attachment systems

    Costs (INR) related to the entire treatment including additional appointments scheduled for repair and/or replacement of prostheses/matrix/matrix components

  4. Technical outcomes:

    Time frame: 6 months after the first and the second evaluation period, respectively

    Questionnaire (Wear of the polymeric and PEEK inserts, Deterioration of the PEEK and polymeric inserts, Initial and final retention of the two attachment systems)

  5. Clinical outcomes: PCR

    Time frame: after a functional period of 6 months for each attachment system; and1, 3 and 5 years after the evaluation period of the second attachment systems

    Plaque control record (PCR) (Questionnaire: 0/1)

  6. Clinical outcomes: BOP

    Time frame: after a functional period of 6 months for each attachment system; and1, 3 and 5 years after the evaluation period of the second attachment systems

    Bleeding on probing (BOP) (Questionnaire: 0/1)

  7. Clinical outcomes: PD

    Time frame: after a functional period of 6 months for each attachment system; and1, 3 and 5 years after the evaluation period of the second attachment systems

    Probing depth (PD) (mm)

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

Evaluation of Patient Reported Outcome Measures and Clinical Performance of Implant Supported Overdentures With Two Different Attachment Systems: A Randomized Cross Over Clinical Study

Acronym: ADLCvsLOC

Important dates

Study start
2020
Primary completion
2022
Study completion
2028
First posted
Sep 10, 2020
Registry last updated
Jun 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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