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Objective: To provide 2-year clinical- and patient-oriented data with regard to mandibular overdenture assisted by 2 immediately loaded unsplinted implants.
In this pre-post design, Phase-I clinical trial, 18 edentate individuals received a new set of complete denture. Then, following standard procedures, 3 threaded implants (OsseoSpeed TXTM, Dentsply Implants, Mölndal, Sweden) were placed in the mandible in each patient, and locator abutments (Zest Anchors LLC, Escondido, U.S.A.) were inserted on the right and left side implants. The midline implant served as a control for within-patient comparison. The immediate loading was conducted within 24 h of surgery. Data were collected at baseline (T0), 12 (T1) and 24 (T2) months after immediate loading. The clinical outcomes included implant survival rate, crestal bone level changes and implant stability. These criteria were assessed through clinical and radiographic examinations as well as resonance frequency analysis. Patient-centered outcomes included patient satisfaction and oral health-related quality of life measured using validated questionnaires. Brunner-Langer approach was used for statistical analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate loading | Experimental | Immediate loading of 2 endo-osseous mandibular implants |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immediate loading | Procedure |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient Satisfaction With the Immediate Loading Protocol | Visual Analogue Scale (VAS) to assess patients' satisfaction, with a score of 100 being extremely satisfied (minimum and maximum scores: 1-100 respectively). | 4 months |
| Oral-health-related Quality of Life With the Immediate Loading Protocol | Oral Health Impact Profile (OHIP-20) to assess oral-health-related quality of life: score ranges between 20 and 120 points, with a lower score indicating a better oral-health-related quality of life. | 4 months |
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Inclusion Criteria:
Exclusion Criteria:
Exclusion Criteria to Immediate Loading Protocol Found on One or Both of Un-splinted Implants During Surgery:
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| Name | Affiliation | Role |
|---|---|---|
| Elham Emami, DDS, MSc,PhD | Université de Montréal, Faculty of Dentistry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Université de Montréal | Montreal | Quebec | H3Y1P2 | Canada |
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Calling patients on the waiting list of the undergraduate implant clinic of the Université de Montréal and referrals from active study subjects.
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| ID | Title | Description |
|---|---|---|
| FG000 | Immediate Loading | Immediate loading of 2 endo-osseous mandibular implants |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Immediate Loading | Immediate loading of 2 endo-osseous mandibular implants |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Patient Satisfaction With the Immediate Loading Protocol | Visual Analogue Scale (VAS) to assess patients' satisfaction, with a score of 100 being extremely satisfied (minimum and maximum scores: 1-100 respectively). | Posted | Mean | Standard Deviation | millimeters | 4 months |
|
|
All participants were assessed for adverse events. "0" participants were found to have serious or non-serious events after observation.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Immediate Loading | Immediate loading of 2 endo-osseous mandibular implants |
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Phase-I clinical trial with small sample size and a pre-post design with no control group.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elham Emami, DDS, MSc, PhD | Université de Montréal | 514-343-6111 | 6053 | elham.emami@umontreal.ca |
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| ID | Term |
|---|---|
| D057893 | Immediate Dental Implant Loading |
| ID | Term |
|---|---|
| D003758 | Dental Implantation, Endosseous |
| D003757 | Dental Implantation |
| D013516 | Oral Surgical Procedures, Preprosthetic |
| D019647 | Oral Surgical Procedures |
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Investigators were not involved in data analysis
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | Oral-health-related Quality of Life With the Immediate Loading Protocol | Oral Health Impact Profile (OHIP-20) to assess oral-health-related quality of life: score ranges between 20 and 120 points, with a lower score indicating a better oral-health-related quality of life. | Posted | Mean | Standard Deviation | units on a scale | 4 months |
|
|
|
| 0 |
| 18 |
| 0 |
| 18 |
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| D013514 | Surgical Procedures, Operative |
| D019919 | Prosthesis Implantation |
| D003813 | Dentistry |
| D011476 | Prosthodontics |