Trial Outcomes & Findings for Study to Evaluate Bone and Gum Dimension Changes Around Dental Implants Placed in Different Positions in Bone. (NCT NCT01759537)

Last Updated: 2022-12-29

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

48 participants

Primary outcome timeframe

Implant placement, and 18 months and 30 months after implant placement

Results posted on

2022-12-29

Participant Flow

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.

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.

Unit of analysis: implants

Participant milestones

Participant milestones
Measure	Implants Placed at Sub-crestal Position Ankylos dental endosseous implants placed at sub-crestal position	Implants Placed at Epi-crestal Position Ankylos dental endosseous implants placed at epi-crestal position
Overall Study STARTED	48 48	48 48
Overall Study COMPLETED	35 35	35 35
Overall Study NOT COMPLETED	13 13	13 13

Reasons for withdrawal

Reasons for withdrawal
Measure	Implants Placed at Sub-crestal Position Ankylos dental endosseous implants placed at sub-crestal position	Implants Placed at Epi-crestal Position Ankylos dental endosseous implants placed at epi-crestal position
Overall Study Death	1	1
Overall Study Pregnancy	1	1
Overall Study Lost to Follow-up	9	9
Overall Study Accident involving jaw fracture	1	1
Overall Study Subcrestal implant too coronal	1	1

Baseline Characteristics

Study to Evaluate Bone and Gum Dimension Changes Around Dental Implants Placed in Different Positions in Bone.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Implants Placed at Sub-crestal Position and Epi-crestal Position n=45 Participants Ankylos dental endosseous implants-sub-crestal and epi-crestal Ankylos dental endosseous implants-sub-crestal and epi-crestal: Implants placed subcrestally and epi-crestally
Age, Continuous	45.3 years STANDARD_DEVIATION 11.11 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	13 Participants n=5 Participants
Race (NIH/OMB) White	21 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	7 Participants n=5 Participants
Region of Enrollment United States	45 Participants n=5 Participants

PRIMARY outcome

Timeframe: Implant placement, and 18 months and 30 months after implant placement

Population: All subjects available at each time point are included in the analysis.

Outcome measures

Outcome measures
Measure	Implants Placed at Sub-crestal Position n=43 implants Ankylos dental endosseous implants placed at sub-crestal position	Implants Placed at Epi-crestal Position n=43 implants Ankylos dental endosseous implants placed at epi-crestal position
Change in Marginal Bone Level (MBL) Mean MBL (Buccal) at 18 months after implant placement	-0.14 mm Standard Deviation 0.78	-0.002 mm Standard Deviation 0.99
Change in Marginal Bone Level (MBL) Mean MBL (Lingual) at 18 months after implant placement	-0.20 mm Standard Deviation 0.59	-0.07 mm Standard Deviation 0.63
Change in Marginal Bone Level (MBL) Mean MBL (Buccal) at 30 months after implant placement	-0.19 mm Standard Deviation 0.99	0.36 mm Standard Deviation 0.95
Change in Marginal Bone Level (MBL) Mean MBL (Lingual) at 30 months after implant placement	-0.26 mm Standard Deviation 0.57	0.27 mm Standard Deviation 0.62

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Implants Placed at Sub-crestal Position n=43 implants Ankylos dental endosseous implants placed at sub-crestal position	Implants Placed at Epi-crestal Position n=43 implants Ankylos dental endosseous 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	-0.17 mm Standard Deviation 0.91	-0.11 mm Standard Deviation 0.76
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	-0.12 mm Standard Deviation 0.78
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	-0.08 mm Standard Deviation 0.81
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	-0.24 mm Standard Deviation 0.85
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	-0.32 mm Standard Deviation 0.96
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	-0.30 mm Standard Deviation 1.14

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Implants Placed at Sub-crestal Position n=43 implants Ankylos dental endosseous implants placed at sub-crestal position	Implants Placed at Epi-crestal Position n=43 implants Ankylos dental endosseous implants placed at epi-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	0.28 mm Standard Deviation 0.46
Change of Interproximal Levels After Final Restoration Change in interproximal level at 30 months after implant placement	0.25 mm Standard Deviation 0.44	0.30 mm Standard Deviation 0.44
Change of Interproximal Levels After Final Restoration Change in interproximal level at 42 months after implant placement	0.24 mm Standard Deviation 0.49	0.29 mm Standard Deviation 0.50
Change of Interproximal Levels After Final Restoration Change in interproximal level at 54 months after implant placement	0.23 mm Standard Deviation 0.54	0.31 mm Standard Deviation 0.55
Change of Interproximal Levels After Final Restoration Change in interproximal level at 66 months after implant placement	0.16 mm Standard Deviation 0.56	0.26 mm Standard Deviation 0.64

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Implants Placed at Sub-crestal Position n=35 implants Ankylos dental endosseous implants placed at sub-crestal position	Implants Placed at Epi-crestal Position n=35 implants Ankylos dental endosseous implants placed at epi-crestal position
Change in Marginal Bone Level (MBL) Mean MBL (Buccal) at 66 months after implant placement	-0.64 mm Standard Deviation 1.66	-0.30 mm Standard Deviation 2.11
Change in Marginal Bone Level (MBL) Mean MBL (Lingual) at 66 months after implant placement	-0.34 mm Standard Deviation 0.81	0.07 mm Standard Deviation 0.74

Adverse Events

Implants Placed at Sub-crestal Position

Serious events: 2 serious events

Other events: 17 other events

Deaths: 1 deaths

Implants Placed at Epi-crestal Position

Serious events: 2 serious events

Other events: 11 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Implants Placed at Sub-crestal Position n=48 participants at risk Ankylos dental endosseous implants placed at sub-crestal position	Implants Placed at Epi-crestal Position n=48 participants at risk Ankylos dental endosseous implants placed at epi-crestal position
General disorders Death	2.1% 1/48 • Number of events 1 • Adverse event data was collected from initial implant to 60 months after final restoration	2.1% 1/48 • Number of events 1 • Adverse event data was collected from initial implant to 60 months after final restoration
Musculoskeletal and connective tissue disorders Fracture	2.1% 1/48 • Number of events 1 • Adverse event data was collected from initial implant to 60 months after final restoration	2.1% 1/48 • Number of events 1 • Adverse event data was collected from initial implant to 60 months after final restoration

Other adverse events

Other adverse events
Measure	Implants Placed at Sub-crestal Position n=48 participants at risk Ankylos dental endosseous implants placed at sub-crestal position	Implants Placed at Epi-crestal Position n=48 participants at risk Ankylos dental endosseous implants placed at epi-crestal position
Product Issues Healing abutment lost	12.5% 6/48 • Number of events 6 • Adverse event data was collected from initial implant to 60 months after final restoration	4.2% 2/48 • Number of events 2 • Adverse event data was collected from initial implant to 60 months after final restoration
Product Issues Provisional crown loosened/lost	6.2% 3/48 • Number of events 3 • Adverse event data was collected from initial implant to 60 months after final restoration	4.2% 2/48 • Number of events 3 • Adverse event data was collected from initial implant to 60 months after final restoration
Product Issues Provisional crown chipped/fractured	0.00% 0/48 • Adverse event data was collected from initial implant to 60 months after final restoration	2.1% 1/48 • Number of events 1 • Adverse event data was collected from initial implant to 60 months after final restoration
Product Issues Final crown loosened/lost	14.6% 7/48 • Number of events 8 • Adverse event data was collected from initial implant to 60 months after final restoration	8.3% 4/48 • Number of events 6 • Adverse event data was collected from initial implant to 60 months after final restoration
Product Issues Final crown chipped/fractured	8.3% 4/48 • Number of events 4 • Adverse event data was collected from initial implant to 60 months after final restoration	8.3% 4/48 • Number of events 5 • Adverse event data was collected from initial implant to 60 months after final restoration

Additional Information

Ismael Khouly

NYU College of Dentistry

Phone: 212-998-9800

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60