Edentulism
Conditions
Keywords
subjects with edentulous mandible
Brief summary
Change in crestal bone level implants at 5% significance level.
Interventions
DEVICEAnkylos Implants
ANKYLOS Implant System vs Certain PREVAIL Implant
DEVICEBiomet 3i Prevail Implants
Sponsors
Dentsply International
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* age 18 to 80 * male or female (female non-pregnant) * sufficient oral hygiene * no inflammation/disorder in the area of implant site * edentulous mandible and sufficient prosthetic and conservative * sufficient width and height of bone to place implants with diameters of 4.8mm and length of 11 mm * provide written informed consent
Exclusion criteria
* demonstrate a need for pre-surgical bone or soft tissue augmentation in planned implant areas * exhibit angulation requirements of restoration exceeding 15 degrees * systemic metabolic disorder that would compromise post-operative tissue regeneration or osseointegration * taking medication that would compromise post-operative healing and/or osseointegration * bone disorders such as osteoporosis, hyperparathyroidism, Paget's disease, diabetes mellitus * oncology treatment * oral infection * acute gingivitis and/or periodontitis * local bone defects in the area of planned implantation * disorders of oral mucosa (e.g., leukoplakia, oral lichen, pemphigoid lesions) * received investigational drug within 30 days * history of illicit drugs or alcohol abuse * history of addiction to medication * allergic to dental materials * nicotine abuse (\> 20 cigarettes/day) * pregnant or nursing * clinical significant or unstable medical or physiological conditions that would compromise participation in study * unable or unwilling to return for follow-up visits for a period of 24 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness - Treatment Difference in Mean Change in Crestal Bone Level | 6 months after surgery | Incidence of greater than 2 mm crestal bone (mesial or distal) loss. Reported in the percentage of analyzed implants. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dental Implants. 3 Ankylos dental implants placed in platform switch configuration on one side of the mandible in support of a fixed restoration.
Ankylos Implants: ANKYLOS Implant System vs Certain PREVAIL Implant in split mouth study.
A total of 19 subjects participated in this randomized, split-mouth, masked, prospective, open, comparison, monocenter study. Participants were subjects with an edentulous mandible who received 3 implants on each side which were splinted for the delivery of a fixed prosthesis.
After a baseline phase of 1 month the mandible sides of subjects were randomly assigned to one of 2 parallel treatment groups: one side received ANKYLOS® plus Implants. The contralateral side received Certain® PREVAILTM Implants. Abutments were installed and loaded immediately by a fixed temporary bridge. After 3 months the final prosthesis was incorporated. | 19 |
| Total | 19 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | Dental Implants. |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants |
| Region of Enrollment United States | 19 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 19 |
| serious Total, serious adverse events | 0 / 19 |
Outcome results
Primary
Effectiveness - Treatment Difference in Mean Change in Crestal Bone Level
Incidence of greater than 2 mm crestal bone (mesial or distal) loss. Reported in the percentage of analyzed implants.
Time frame: 6 months after surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ankylos Dental Implants. | Effectiveness - Treatment Difference in Mean Change in Crestal Bone Level | 13 Percentage of implants |
| 3i Prevail Dental Implants. | Effectiveness - Treatment Difference in Mean Change in Crestal Bone Level | 55 Percentage of implants |
Primary
Effectiveness - Treatment Difference in Mean Change in Crestal Bone Level
Incidence of greater than 2 mm crestal bone (mesial or distal) loss. Reported in the percentage of analyzed implants.
Time frame: 12 months after surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ankylos Dental Implants. | Effectiveness - Treatment Difference in Mean Change in Crestal Bone Level | 20 Percentage of implants |
| 3i Prevail Dental Implants. | Effectiveness - Treatment Difference in Mean Change in Crestal Bone Level | 56 Percentage of implants |
Primary
Effectiveness - Treatment Difference in Mean Change in Crestal Bone Level
Incidence of greater than 2 mm crestal bone (mesial or distal) loss. Reported in the percentage of analyzed implants.
Time frame: 24 months after surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ankylos Dental Implants. | Effectiveness - Treatment Difference in Mean Change in Crestal Bone Level | 11 Percentage of implants |
| 3i Prevail Dental Implants. | Effectiveness - Treatment Difference in Mean Change in Crestal Bone Level | 70 Percentage of implants |