Dental Implantation
Conditions
Keywords
immediate-loading, patient-based outcomes
Brief summary
Objective: To provide 2-year clinical- and patient-oriented data with regard to mandibular overdenture assisted by 2 immediately loaded unsplinted implants.
Detailed description
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.
Interventions
PROCEDUREImmediate loading
Sponsors
Université de Montréal
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
Investigators were not involved in data analysis
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Minimal age of 18 years * Complete edentulism for more than 1 year * Wear of total conventional prosthesis for more than 1 year * Bone morphology in the anterior mandibular region amendable for the placement of 3 regular diameter implants without any additional procedure (graft or membrane).
Exclusion criteria
* Any absolute or relative contra-indication to implant therapy * Physical incapacity to render oral or prosthetic hygiene * Incapacity to obtain a free and informed consent * Incapacity to assist to planned follow up appointments * Incapacity to understand and complete questionnaires
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction With the Immediate Loading Protocol | 4 months | Visual Analogue Scale (VAS) to assess patients' satisfaction, with a score of 100 being extremely satisfied (minimum and maximum scores: 1-100 respectively). |
| Oral-health-related Quality of Life With the Immediate Loading Protocol | 4 months | 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. |
Countries
Canada
Participant flow
Recruitment details
Calling patients on the waiting list of the undergraduate implant clinic of the Université de Montréal and referrals from active study subjects.
Participants by arm
| Arm | Count |
|---|---|
| Immediate Loading Immediate loading of 2 endo-osseous mandibular implants | 18 |
| Total | 18 |
Baseline characteristics
| Characteristic | Immediate Loading |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 9 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants |
| Age, Continuous | 62.4 years STANDARD_DEVIATION 7.65 |
| Region of Enrollment Canada | 18 participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 18 |
| serious Total, serious adverse events | 0 / 18 |
Outcome results
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.
Time frame: 4 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Loading | Oral-health-related Quality of Life With the Immediate Loading Protocol | 66.8 units on a scale | Standard Deviation 19.1 |
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).
Time frame: 4 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Loading | Patient Satisfaction With the Immediate Loading Protocol | 40.3 millimeters | Standard Deviation 34.9 |