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| ID | Type | Description | Link |
|---|---|---|---|
| 1185_2016 | Other Grant/Funding Number | ITI - International Team for Implantology |
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| Name | Class |
|---|---|
| ITI International Team for Implantology, Switzerland | OTHER |
| Institut Straumann AG | INDUSTRY |
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The objective of this explanatory mixed methods study is to compare a novel attachment system (Novaloc) to a traditional alternative (Locator) for single implants in the mandible of edentate elders. The investigators will carry out a randomized cross-over clinical trial comparing Novaloc attachments to Locators for single-implant mandibular overdentures in edentate elders. Participants will be followed for three months with each attachment type; patient-based, clinical and economic outcomes will be gathered. A sample of 26 participants is estimated to be required to detect clinically relevant differences in terms of the primary outcome (patient ratings of general satisfaction). Participants will choose which attachment they wish to keep, then be interviewed about their experiences and preferences with a single implant prosthesis and with the 2 attachments. Data from the quantitative and qualitative assessments will be integrated through a mixed-methods explanatory strategy. A last quantitative assessment will take place after 12 months with preferred attachment; this latter assessment will enable the observation of attachments' long-term wear and maintenance events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Novaloc, then Locator | Experimental | Participants will receive the Novaloc attachment on a single implant inserted in the mandibular midline. This attachment will be used for 3 months and then changed by the Locator attachment. The second attachment will be used for another 3-month period. Participants will keep preferred attachment for further 12 months |
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| Locator, then Novaloc | Active Comparator | Participants will receive the Locator attachment on a single implant inserted in the mandibular midline. This attachment will be used for 3 months and then changed by the Novaloc attachment. The second attachment will be used for another 3-month period. Participants will keep preferred attachment for further 12 months |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Novaloc | Device | Attachment composed by a polyetheretherketone (PEEK) capsule and carbon-coated abutment. The yellow (medium) retentive component will be used |
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| Measure | Description | Time Frame |
|---|---|---|
| Denture satisfaction | To be assessed by specific questionnaires | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Oral health-related quality of life | To be assessed by the OHIP-EDENT (Oral Health Impact Profile, shortened version for edentulous subjects) questionnaire | 18 months |
| Overdenture rotation | Two questions regarding perceived rotation, as done by Kimoto et al. (Clin Oral Implants Res 2009;20:838-43) |
| Measure | Description | Time Frame |
|---|---|---|
| Qualitative assessment | Qualitative assessment (descriptive approach based on transcribed interviews) regarding: a) patients' reasons for choosing one attachment system; b) their perceptions of the advantages and disadvantages of each attachment; and c) their experience of living with a single implant retention for their mandibular overdenture | 6 months |
Inclusion Criteria:
Exclusion Criteria:
Following radiographic exam, investigators will exclude volunteers with bony pathologic lesions, less than 11 mm of minimum vertical mandibular bone height in the midline or width for planned implants, evident endosseous vascular structures or mandibular ridges with remaining alveolar sockets
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| Name | Affiliation | Role |
|---|---|---|
| Raphael F de Souza | McGill University, Faculty of Dentistry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McGill University, Faculty of Dentistry | Montreal | Quebec | H3A1G1 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36127832 | Derived | de Souza RF, Jabbar AA, Jafarpour D, Bedos C, Esfandiari S, Makhoul NM, Dagdeviren D, Abi Nader S, Feine JS. Single-Implant Overdentures Retained by a Novel Attachment: A Mixed Methods Crossover Randomized Clinical Trial. JDR Clin Trans Res. 2024 Jan;9(1):27-41. doi: 10.1177/23800844221124083. Epub 2022 Sep 20. | |
| 29685161 | Derived |
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| ID | Term |
|---|---|
| D009066 | Mouth, Edentulous |
| D007575 | Jaw, Edentulous |
| D010342 | Patient Acceptance of Health Care |
| D017060 | Patient Satisfaction |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D014076 | Tooth Diseases |
| D007571 | Jaw Diseases |
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| Locator | Device | Traditional cylindrical attachment (Locator system) with pink (medium) retentive components |
|
| 18 months |
| Success/survival rate | Success/survival rate of prostheses and implants (yes/no) | 18 months |
| Plaque Index | Presence of plaque according to Silness & Loe (Acta Odont Scand 1963;21:533-51) (ordinal scale ranging from 0 to 3) | 18 months |
| Presence of calculus | Presence of calculus according to Ramfjord (J Periodontol 1967;38:602-10) (ordinal scale ranging from 0 to 3) | 18 months |
| Peri-implant probing depth | Depth of peri-implant pockets (in mm) | 18 months |
| Bleeding on probing | Bleeding on probing around implant (yes/no) | 18 months |
| Mucosal inflammation | Signs of swelling or inflammation of the peri-implant-mucosa (yes/no, plus categorical evaluation - type of pathological change) | 18 months |
| Treatment costs | Specific forms quantifying costs involved with cost of labor, materials, radiographs, medications, patient's time and transportation expenses | 18 months |
| de Souza RF, Bedos C, Esfandiari S, Makhoul NM, Dagdeviren D, Abi Nader S, Jabbar AA, Feine JS. Single-implant overdentures retained by the Novaloc attachment system: study protocol for a mixed-methods randomized cross-over trial. Trials. 2018 Apr 23;19(1):243. doi: 10.1186/s13063-018-2606-7. |
| D009140 |
| Musculoskeletal Diseases |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |