Clinical Evaluation of Two Different Attachment System

Official 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

Overview

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.

Interventions

• Device ADLC attachment system with PEEK inserts
  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 p

Primary outcome measures

• Patient reported outcome measure [Time frame: After a functional period of 6 months]

Secondary outcome measures (7)

• Patient-Reported Outcome Measures (PROMs): VAS [Time frame: 6 months, 1, 3, 5 years after the evaluation period of the second attachment systems]
• Patient-Reported Outcome Measures (PROMs): OHIP-14 [Time frame: 6 months, 1, 3, 5 years after the evaluation period of the second attachment systems]
• Patient-Reported Outcome Measures (PROMs): Costs [Time frame: 6 months, 1, 3, 5 years after the evaluation period of the second attachment systems]
• Technical outcomes: [Time frame: 6 months after the first and the second evaluation period, respectively]
• 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]
• 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]
• 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Crossover

Masking

Single blind

Primary purpose

Treatment

Study locations

India · 1 center

• M.A.Rangoonwala College of Dental Sciences & Research Center — Pune

Identifiers

NCT: NCT04544839 · MCES/EC/613/2020

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗