Mouth, Edentulous
Conditions
Brief summary
The purpose of this study is to test two standard of care techniques of placing dental implants, and to compare how people's bones and gums respond to two different depths at which implants are placed.
Detailed description
The purpose of this study is to test epicrestal and subcrestal placement of dental implants, and to compare how people's bones and gums respond to two different depths at which implants are placed.
Interventions
DEVICEAnkylos dental endosseous implants-Sub-crestal
Implants placed subcrestally
DEVICEAnkylos dental endosseous implants-Epi-crestal
Implants placed Epi-crestally
Sponsors
Dentsply International
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Intervention model description
This was a split mouth study design in which the same patient was used for both arms.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
1. Subjects must have read, understood and signed an informed consent form; 2. Subjects must be 18 to 70 years of age; 3. Subjects must be able and willing to follow study procedures and instructions; 4. Subjects must have indication to receive two implants in a bilateral maxillary or mandibular edentulous areas (for at least 4 months post extraction) in areas of pre-molars (first or second) and molars (first or second); 5. Sufficient width and height of bone to place at least 8mm length and any compatible in diameter Ankylos implant; 6. Sufficient vertical clearance to place a single tooth crown replacement; 7. No apical disorder/inflammation at the area of the implant site.
Exclusion criteria
1. Subjects participating in other clinical studies within 1 month prior to screening and/or involving therapeutic intervention (either medical or dental) that could affect bone or soft tissue healing; 2. Female subjects who are pregnant or lactating, or who intend to become pregnant during the study period following entrance into the study; 3. Subjects with parafunctional habits; 4. Subjects who have failed to maintain good plaque control; 5. Subjects with any systemic condition like uncontrolled diabetes mellitus, cancer, HIV, disorders that compromise wound healing, chronic high dose steroid therapy, bone metabolic diseases, radiation or other immuno-suppressive therapy which would preclude periodontal surgery; 6. Absence of occlusal stability in centric occlusion; 7. Subjects with the presence of acute infectious lesions in the areas intended for surgery; 8. History within the last 3 months of weekly or more frequent use of smokeless chewing tobacco, pipe or cigar smoking and cigarette smoking (greater than 10 cigarettes per day) 9. Present alcohol or drug abuse; 10. Angulation requirements of the restoration exceeding approximately 15 degrees; 11. Systemic corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration (e.g. calcium channel blocker, dilantin).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Marginal Bone Level (MBL) | Implant placement, and 18 months and 30 months after implant placement | Changes in MBLs at 18 months and 30 months after implant placement were chosen as primary outcome parameters. Results are described as mean values and standard deviations. Note: Mean changes in MBL for epicrestal and subcrestal placements at lingual and buccal sites is also referred to as mid-facial bone levels. To determine MBL changes between T0 and each follow-up visit, MBLs at T0 were subtracted from the complementary values for that implant at T18 and T30. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Mid-Buccal Soft Tissue Height | From final restoration (6 months after implant placement), and 12 months, 18 months, 30 months, 42 months, 54 months, and 66 months after implant placement | Soft tissue levels were measured clinically from a fixed reference point to the mid buccal soft tissue margin using a stent. Measurements were made from fixed reference points, by using a stent to perform clinical measurements in a reproducible position. |
| Change of Interproximal Levels After Final Restoration | From final restoration (6 months after implant placement), and 18 months, 30 months, 42 months, 54 months, and 66 months after implant placement | Analysis of interproximal bone height change measured by periapical radiographs. The height of the papilla will be assessed at the mesial and distal sites of the implants, by means of the published papilla Jemt index. Measurements will be assessed by reviewing the clinical photographs. Reference: Jemt, T. (1997) Regeneration of gingival papillae after single-implant treatment. International Journal of Periodontics and Restorative Dentistry 17: 326-333. |
| Change in Marginal Bone Level (MBL) | Implant placement, and 66 months after implant placement | Changes in MBLs at 66 months after implant placement were chosen as a secondary outcome parameter. Results are described as mean values and standard deviations. Note: Mean changes in MBL for epicrestal and subcrestal placements at lingual and buccal sites is also referred to as mid-facial bone levels. To determine MBL changes between T0 and each follow-up visit, MBLs at T0 were subtracted from the complementary values for that implant at T18, T30 and T66. |
Countries
United States
Participant flow
Recruitment details
Subjects who fulfilled the inclusion criteria and required two bilateral implants in the pre-molar (first or second) or molar (first or second) region of the maxilla or mandible, ages 18 through 70 years old were eligible to participate in this study. Patient screenings, enrollment, study procedures, and data collection was conducted at the Bluestone Center for Clinical Research (BCCR), New York University (NYU) College of Dentistry, from April 2012 to April 2019.
Pre-assignment details
Of the 1022 participants who were assessed for eligibility, 974 were excluded as they did not meet the inclusion criteria, did not show for evaluation, or for other reasons. Forty-eight (48) met inclusion criteria and were randomized to treatment.
Participants by arm
| Arm | Count |
|---|---|
| Implants Placed at Sub-crestal Position and Epi-crestal Position Ankylos dental endosseous implants-sub-crestal and epi-crestal
Ankylos dental endosseous implants-sub-crestal and epi-crestal: Implants placed subcrestally and epi-crestally | 45 |
| Total | 45 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Accident involving jaw fracture | 1 | 1 |
| Overall Study | Death | 1 | 1 |
| Overall Study | Lost to Follow-up | 9 | 9 |
| Overall Study | Pregnancy | 1 | 1 |
| Overall Study | Subcrestal implant too coronal | 1 | 1 |
Baseline characteristics
| Characteristic | Implants Placed at Sub-crestal Position and Epi-crestal Position |
|---|---|
| Age, Continuous | 45.3 years STANDARD_DEVIATION 11.11 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants |
| Race (NIH/OMB) Black or African American | 13 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants |
| Race (NIH/OMB) White | 21 Participants |
| Region of Enrollment United States | 45 Participants |
| Sex: Female, Male Female | 22 Participants |
| Sex: Female, Male Male | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 48 | 1 / 48 |
| other Total, other adverse events | 17 / 48 | 11 / 48 |
| serious Total, serious adverse events | 2 / 48 | 2 / 48 |
Outcome results
Primary
Change in Marginal Bone Level (MBL)
Changes in MBLs at 18 months and 30 months after implant placement were chosen as primary outcome parameters. Results are described as mean values and standard deviations. Note: Mean changes in MBL for epicrestal and subcrestal placements at lingual and buccal sites is also referred to as mid-facial bone levels. To determine MBL changes between T0 and each follow-up visit, MBLs at T0 were subtracted from the complementary values for that implant at T18 and T30.
Time frame: Implant placement, and 18 months and 30 months after implant placement
Population: All subjects available at each time point are included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Implants Placed at Sub-crestal Position | Change in Marginal Bone Level (MBL) | Mean MBL (Buccal) at 18 months after implant placement | -0.14 mm | Standard Deviation 0.78 |
| Implants Placed at Sub-crestal Position | Change in Marginal Bone Level (MBL) | Mean MBL (Lingual) at 18 months after implant placement | -0.20 mm | Standard Deviation 0.59 |
| Implants Placed at Sub-crestal Position | Change in Marginal Bone Level (MBL) | Mean MBL (Buccal) at 30 months after implant placement | -0.19 mm | Standard Deviation 0.99 |
| Implants Placed at Sub-crestal Position | Change in Marginal Bone Level (MBL) | Mean MBL (Lingual) at 30 months after implant placement | -0.26 mm | Standard Deviation 0.57 |
| Implants Placed at Epi-crestal Position | Change in Marginal Bone Level (MBL) | Mean MBL (Lingual) at 30 months after implant placement | 0.27 mm | Standard Deviation 0.62 |
| Implants Placed at Epi-crestal Position | Change in Marginal Bone Level (MBL) | Mean MBL (Buccal) at 18 months after implant placement | -0.002 mm | Standard Deviation 0.99 |
| Implants Placed at Epi-crestal Position | Change in Marginal Bone Level (MBL) | Mean MBL (Buccal) at 30 months after implant placement | 0.36 mm | Standard Deviation 0.95 |
| Implants Placed at Epi-crestal Position | Change in Marginal Bone Level (MBL) | Mean MBL (Lingual) at 18 months after implant placement | -0.07 mm | Standard Deviation 0.63 |
Secondary
Change in Marginal Bone Level (MBL)
Changes in MBLs at 66 months after implant placement were chosen as a secondary outcome parameter. Results are described as mean values and standard deviations. Note: Mean changes in MBL for epicrestal and subcrestal placements at lingual and buccal sites is also referred to as mid-facial bone levels. To determine MBL changes between T0 and each follow-up visit, MBLs at T0 were subtracted from the complementary values for that implant at T18, T30 and T66.
Time frame: Implant placement, and 66 months after implant placement
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Implants Placed at Sub-crestal Position | Change in Marginal Bone Level (MBL) | Mean MBL (Buccal) at 66 months after implant placement | -0.64 mm | Standard Deviation 1.66 |
| Implants Placed at Sub-crestal Position | Change in Marginal Bone Level (MBL) | Mean MBL (Lingual) at 66 months after implant placement | -0.34 mm | Standard Deviation 0.81 |
| Implants Placed at Epi-crestal Position | Change in Marginal Bone Level (MBL) | Mean MBL (Buccal) at 66 months after implant placement | -0.30 mm | Standard Deviation 2.11 |
| Implants Placed at Epi-crestal Position | Change in Marginal Bone Level (MBL) | Mean MBL (Lingual) at 66 months after implant placement | 0.07 mm | Standard Deviation 0.74 |
Secondary
Change in Mid-Buccal Soft Tissue Height
Soft tissue levels were measured clinically from a fixed reference point to the mid buccal soft tissue margin using a stent. Measurements were made from fixed reference points, by using a stent to perform clinical measurements in a reproducible position.
Time frame: From final restoration (6 months after implant placement), and 12 months, 18 months, 30 months, 42 months, 54 months, and 66 months after implant placement
Population: All subjects available at each time point are included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Implants Placed at Sub-crestal Position | Change in Mid-Buccal Soft Tissue Height | Change in Mid-Buccal Soft Tissue Height at 12 months after implant placement | -0.17 mm | Standard Deviation 0.91 |
| Implants Placed at Sub-crestal Position | Change in Mid-Buccal Soft Tissue Height | Change in Mid-Buccal Soft Tissue Height at 18 months after implant placement | -0.11 mm | Standard Deviation 0.86 |
| Implants Placed at Sub-crestal Position | Change in Mid-Buccal Soft Tissue Height | Change in Mid-Buccal Soft Tissue Height at 30 months after implant placement | -0.26 mm | Standard Deviation 0.87 |
| Implants Placed at Sub-crestal Position | Change in Mid-Buccal Soft Tissue Height | Change in Mid-Buccal Soft Tissue Height at 42 months after implant placement | -0.46 mm | Standard Deviation 0.96 |
| Implants Placed at Sub-crestal Position | Change in Mid-Buccal Soft Tissue Height | Change in Mid-Buccal Soft Tissue Height at 54 months after implant placement | -0.55 mm | Standard Deviation 0.81 |
| Implants Placed at Sub-crestal Position | Change in Mid-Buccal Soft Tissue Height | Change in Mid-Buccal Soft Tissue Height at 66 months after implant placement | -0.40 mm | Standard Deviation 0.83 |
| Implants Placed at Epi-crestal Position | Change in Mid-Buccal Soft Tissue Height | Change in Mid-Buccal Soft Tissue Height at 54 months after implant placement | -0.32 mm | Standard Deviation 0.96 |
| Implants Placed at Epi-crestal Position | Change in Mid-Buccal Soft Tissue Height | Change in Mid-Buccal Soft Tissue Height at 12 months after implant placement | -0.11 mm | Standard Deviation 0.76 |
| Implants Placed at Epi-crestal Position | Change in Mid-Buccal Soft Tissue Height | Change in Mid-Buccal Soft Tissue Height at 42 months after implant placement | -0.24 mm | Standard Deviation 0.85 |
| Implants Placed at Epi-crestal Position | Change in Mid-Buccal Soft Tissue Height | Change in Mid-Buccal Soft Tissue Height at 18 months after implant placement | -0.12 mm | Standard Deviation 0.78 |
| Implants Placed at Epi-crestal Position | Change in Mid-Buccal Soft Tissue Height | Change in Mid-Buccal Soft Tissue Height at 66 months after implant placement | -0.30 mm | Standard Deviation 1.14 |
| Implants Placed at Epi-crestal Position | Change in Mid-Buccal Soft Tissue Height | Change in Mid-Buccal Soft Tissue Height at 30 months after implant placement | -0.08 mm | Standard Deviation 0.81 |
Secondary
Change of Interproximal Levels After Final Restoration
Analysis of interproximal bone height change measured by periapical radiographs. The height of the papilla will be assessed at the mesial and distal sites of the implants, by means of the published papilla Jemt index. Measurements will be assessed by reviewing the clinical photographs. Reference: Jemt, T. (1997) Regeneration of gingival papillae after single-implant treatment. International Journal of Periodontics and Restorative Dentistry 17: 326-333.
Time frame: From final restoration (6 months after implant placement), and 18 months, 30 months, 42 months, 54 months, and 66 months after implant placement
Population: All subjects available at each time point are included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Implants Placed at Sub-crestal Position | Change of Interproximal Levels After Final Restoration | Change in interproximal level at 30 months after implant placement | 0.25 mm | Standard Deviation 0.44 |
| Implants Placed at Sub-crestal Position | Change of Interproximal Levels After Final Restoration | Change in interproximal level at 54 months after implant placement | 0.23 mm | Standard Deviation 0.54 |
| Implants Placed at Sub-crestal Position | Change of Interproximal Levels After Final Restoration | Change in interproximal level at 42 months after implant placement | 0.24 mm | Standard Deviation 0.49 |
| Implants Placed at Sub-crestal Position | Change of Interproximal Levels After Final Restoration | Change in interproximal level at 66 months after implant placement | 0.16 mm | Standard Deviation 0.56 |
| Implants Placed at Sub-crestal Position | Change of Interproximal Levels After Final Restoration | Change in interproximal level at 18 months after implant placement | 0.21 mm | Standard Deviation 0.48 |
| Implants Placed at Epi-crestal Position | Change of Interproximal Levels After Final Restoration | Change in interproximal level at 66 months after implant placement | 0.26 mm | Standard Deviation 0.64 |
| Implants Placed at Epi-crestal Position | Change of Interproximal Levels After Final Restoration | Change in interproximal level at 18 months after implant placement | 0.28 mm | Standard Deviation 0.46 |
| Implants Placed at Epi-crestal Position | Change of Interproximal Levels After Final Restoration | Change in interproximal level at 30 months after implant placement | 0.30 mm | Standard Deviation 0.44 |
| Implants Placed at Epi-crestal Position | Change of Interproximal Levels After Final Restoration | Change in interproximal level at 42 months after implant placement | 0.29 mm | Standard Deviation 0.5 |
| Implants Placed at Epi-crestal Position | Change of Interproximal Levels After Final Restoration | Change in interproximal level at 54 months after implant placement | 0.31 mm | Standard Deviation 0.55 |