Dental Implant Clinical Trial
— ADLCvsLOCOfficial 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
Verified date | June 2022 |
Source | University of Zurich |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Enrolling by invitation |
Enrollment | 26 |
Est. completion date | January 2028 |
Est. primary completion date | December 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
India | M.A.Rangoonwala College of Dental Sciences & Research Center | Pune |
Lead Sponsor | Collaborator |
---|---|
University of Zurich |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patient reported outcome measure | 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 | After a functional period of 6 months | |
Secondary | Patient-Reported Outcome Measures (PROMs): VAS | 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 | 6 months, 1, 3, 5 years after the evaluation period of the second attachment systems | |
Secondary | Patient-Reported Outcome Measures (PROMs): OHIP-14 | OHIP-14 (Oral Health Impact Profile) will be evaluated at screening (Questionnaire) | 6 months, 1, 3, 5 years after the evaluation period of the second attachment systems | |
Secondary | Patient-Reported Outcome Measures (PROMs): Costs | Costs (INR) related to the entire treatment including additional appointments scheduled for repair and/or replacement of prostheses/matrix/matrix components | 6 months, 1, 3, 5 years after the evaluation period of the second attachment systems | |
Secondary | Technical outcomes: | Questionnaire (Wear of the polymeric and PEEK inserts, Deterioration of the PEEK and polymeric inserts, Initial and final retention of the two attachment systems) | 6 months after the first and the second evaluation period, respectively | |
Secondary | Clinical outcomes: PCR | Plaque control record (PCR) (Questionnaire: 0/1) | 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 | |
Secondary | Clinical outcomes: BOP | Bleeding on probing (BOP) (Questionnaire: 0/1) | 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 | |
Secondary | Clinical outcomes: PD | Probing depth (PD) (mm) | 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 |
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