Study Comparing OsseoSpeed™ Implants of Two Different Lengths in the Upper and Lower Posterior Jaw

• Sponsor: Dentsply Sirona Implants (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00545818
• Collaborator: (none)
• Enrollment: 97
• Locations: 6
• Arms: 2
• Duration (Months): 102
• Patients Per Site: 16.2
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

The purpose of this study is to see if OsseoSpeed™ implant 6 mm long is effective for rehabilitation of edentulism and if so, how it compares with OsseoSpeed™ implant 11 mm long. The primary hypothesis is that the alteration in bone level is equal in patients randomized to 6 mm as to patients randomized to 11 mm implants.

Condition or Disease	Intervention/Treatment	Phase
Jaw, Edentulous, Partially	Device: OsseoSpeed™ length 6 mm; Device: OsseoSpeed™ length 11 mm	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 97 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open, Prospective, Randomized, Multi-center Study Comparing OsseoSpeed™ Implant 6 mm With OsseoSpeed™ Implant 11 mm in the Posterior Maxilla and Mandible. A 5-year Follow-up Study.
• Study Start Date: Nov 1, 2007
• Actual Primary Completion Date: May 1, 2016
• Actual Study Completion Date: May 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group-1, Implant length 6 mm Subjects treated with OsseoSpeed™ implant, length: 6 mm	Device: OsseoSpeed™ length 6 mm; OsseoSpeed™ dental implant, length: 6 mm
Other: Group-2, Implant length 11 mm Subjects treated with OsseoSpeed™ implant, length: 11 mm	Device: OsseoSpeed™ length 11 mm; OsseoSpeed™ dental implant, length: 11 mm

Outcome Measures

Primary Outcome Measures

1. Radiological Assessments of Marginal Bone Level Alteration [Evaluated from implant installation to 5 years follow-up after implant placement]

   Marginal Bone Level determined from radiographs and expressed as the difference from a reference point on the implant to the most coronal bone-to-implant contact on the mesial and distal aspect of the implant. Marginal Bone Level expressed in millimeters at the 5 year follow-up visit compared to values obtained at delivery of temporary restoration i.e. loading (baseline). Positive value = bone gain, Negative value = bone loss.

Secondary Outcome Measures

1. Overall Implant Survival [Evaluated 5 years after implant placement]

   Overall implant survival, measured on implant level

2. Evaluation of the Periimplant Mucosa Condition - By Assessment BoP [Measured at the 5-year follow-up visit after loading]

   Condition of the periimplant mucosa by assessment of Bleeding on Probing (BoP). Presented as s count of implants that show presence of BoP.

3. Evaluation of the Periimplant Mucosa Condition - By Assessment of Change in PPD [Evaluated at implant loading and at the 5-year follow-up visit.]

   Condition of the periimplant mucosa by assessment of change in probing pocket depth (PPD). Change in pocket depth expressed in millimeters at the 5-year follow-up visit, compared to values obtained at delivery of permanent restoration, i.e. loading (baseline). Negative value = increased pocket depth.

4. Presence of Plaque [Evaluated at the 5-year follow-up visit after loading.]

   Presence of plaque was evaluated at four surfaces around each study position (mesial, facial, distal and lingual). Plaque was recorded as presence or absence of plaque by visual inspection. A study position was considered as bleeding "yes" if at least one of the four surfaces around the implant showed presence of bleeding on probing.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Provision of informed consent

• Aged 20-70 years at enrolment

• History of edentulism in the study area of at least four months

• Neighboring tooth/teeth to the planned bridge must have natural root(s)

• Presence of natural teeth, partial prosthesis and/or implants in the opposite jaw in contact with the planned bridge.

• Deemed by the investigator to have a bone height of at least 11 mm and a bone width of minimum 6 mm

• Deemed by the investigator as likely to present an initially stable implant situation

Exclusion Criteria:

• Unlikely to be able to comply with study procedures, as judged by the investigator

• Earlier graft procedures in the study area

• Uncontrolled pathologic processes in the oral cavity

• Known or suspected current malignancy

• History of radiation therapy in the head and neck region

• History of chemotherapy within 5 years prior to surgery

• Systemic or local disease or condition that could compromise post-operative healing and/or osseointegration

• Uncontrolled diabetes mellitus

• Corticosteroids or any other medication that could influence post-operative healing and/or osseointegration

• Smoking more than 10 cigarettes/day

• Present alcohol and/or drug abuse

• Involvement in the planning and conduct of the study (applies to both Astra Tech staff and staff at the study site)

• Previous enrolment in the present study.

• Severe non-compliance to protocol as judged by the investigator and/or Astra Tech

• Simultaneous participation in another clinical study, or participation in a clinical study during the last 6 months

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	USC School of Dentistry	Los Angeles	California	United States	90089-0641
2	The University of Iowa, College of Dentistry	Iowa City	Iowa	United States	52242-1010
3	School of Dental Science, University of Melbourne	Melbourne	Victoria	Australia	3010
4	Praktijk De Mondhoek	Apeldoorn		Netherlands	7315
5	Dept. of Parodontology, Göteborg University	Göteborg		Sweden	SE 405 30
6	King's College London Dental Institute at Guy's King's and St Thomas' Hospitals	London		United Kingdom	SE1 9RT

Sponsors and Collaborators

• Dentsply Sirona Implants

Investigators

• Study Director: Anna-Karin Lundgren, Direktor Clinical Research, Dentsply Sirona Implants, Mölndal, SWEDEN

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dentsply Sirona Implants
• ClinicalTrials.gov Identifier: NCT00545818
• Other Study ID Numbers: YA-SHO-0001
• First Posted: Oct 17, 2007
• Last Update Posted: May 19, 2020
• Last Verified: May 1, 2020

• Additional relevant MeSH terms: Jaw, Edentulous; Jaw, Edentulous, Partially

Study Results

Participant Flow

Recruitment Details	97 subjects were enrolled in the study (singed informed consent).Two of those subjects fulfilled exclusion criteria and were removed from the study population before randomization. As a consequence a total of 95 subjects were randomised (assigned to groups) and received study treatment.

Arm/Group Title	Group-1, Implant Length 6 mm	Group-2, Implant Length 11 mm
Arm/Group Description	Subjects treated with OsseoSpeed™ implant, length: 6 mm	Subjects treated with OsseoSpeed™ implant, length: 11 mm
Period Title: Overall Study
STARTED	49	46
COMPLETED	46	39
NOT COMPLETED	3	7

Baseline Characteristics

Arm/Group Title	Group-1, Implant Length 6 mm	Group-2, Implant Length 11 mm	Total
Arm/Group Description	Subjects treated with OsseoSpeed™ implant, length: 6 mm	Subjects treated with OsseoSpeed™ implant, length: 11 mm	Total of all reporting groups
Overall Participants	49	46	95
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	54.8 (9.39)	54.1 (10.04)	54.5 (9.67)
Sex: Female, Male (Count of Participants)
Female	28 57.1%	19 41.3%	47 49.5%
Male	21 42.9%	27 58.7%	48 50.5%
Region of Enrollment (participants) [Number]
Sweden	3 6.1%	2 4.3%	5 5.3%
Netherlands	17 34.7%	16 34.8%	33 34.7%
United States	18 36.7%	14 30.4%	32 33.7%
United Kingdom	7 14.3%	8 17.4%	15 15.8%
Australia	4 8.2%	6 13%	10 10.5%

Outcome Measures

1. Primary Outcome

Title	Radiological Assessments of Marginal Bone Level Alteration
Description	Marginal Bone Level determined from radiographs and expressed as the difference from a reference point on the implant to the most coronal bone-to-implant contact on the mesial and distal aspect of the implant. Marginal Bone Level expressed in millimeters at the 5 year follow-up visit compared to values obtained at delivery of temporary restoration i.e. loading (baseline). Positive value = bone gain, Negative value = bone loss.
Time Frame	Evaluated from implant installation to 5 years follow-up after implant placement

Outcome Measure Data

Analysis Population Description

A total of 85 subjects (184 implants) completed the study. For a total of 10 implants (in 5 subjects) the quality of the radiographs were not sufficient for reading, giving a total of 80 subjects (174 implants) for the analysis of MBL change.

Arm/Group Title	Group-1, Implant Length 6 mm	Group-2, Implant Length 11 mm
Arm/Group Description	Subjects treated with OsseoSpeed™ implant, length: 6 mm	Subjects treated with OsseoSpeed™ implant, length: 11 mm
Measure Participants	44	36
Measure Implants	94	80
Mean (Standard Deviation) [millimeter]	0.02 (0.52)	-0.18 (1.05)

2. Secondary Outcome

Title	Overall Implant Survival
Description	Overall implant survival, measured on implant level
Time Frame	Evaluated 5 years after implant placement

Outcome Measure Data

Analysis Population Description

Group-1. A total of 49 subjects (108 positions) underwent surgery. Three positions were not implanted due to complications during surgery. Giving a total 105 implants installed. Group-2. A total of 46 subjects (101 positions) underwent surgery. Giving a total of 101 implants installed.

Arm/Group Title	Group-1, Implant Length 6 mm	Group-2, Implant Length 11 mm
Arm/Group Description	Subjects treated with OsseoSpeed™ implant, length: 6 mm	Subjects treated with OsseoSpeed™ implant, length: 11 mm
Measure Participants	49	46
Measure implants	105	101
Count of Units [implants]	101	100

3. Secondary Outcome

Title	Evaluation of the Periimplant Mucosa Condition - By Assessment BoP
Description	Condition of the periimplant mucosa by assessment of Bleeding on Probing (BoP). Presented as s count of implants that show presence of BoP.
Time Frame	Measured at the 5-year follow-up visit after loading

Outcome Measure Data

Analysis Population Description

A total of 85 subjects (184 implants) completed the 5-year follow-up visit. All included in the assessment of BoP.

Arm/Group Title	Group-1, Implant Length 6 mm	Group-2, Implant Length 11 mm
Arm/Group Description	Subjects treated with OsseoSpeed™ implant, length: 6 mm	Subjects treated with OsseoSpeed™ implant, length: 11 mm
Measure Participants	46	39
Measure implants	98	86
Count of Units [implants]	43	28

4. Secondary Outcome

Title	Evaluation of the Periimplant Mucosa Condition - By Assessment of Change in PPD
Description	Condition of the periimplant mucosa by assessment of change in probing pocket depth (PPD). Change in pocket depth expressed in millimeters at the 5-year follow-up visit, compared to values obtained at delivery of permanent restoration, i.e. loading (baseline). Negative value = increased pocket depth.
Time Frame	Evaluated at implant loading and at the 5-year follow-up visit.

Outcome Measure Data

Analysis Population Description

A total of 85 subjects (184 implants) completed the 5-year follow-up visit. Group-1. For 3 subjects (7 implants) the radiographs were not possible to evaluate, giving a total of 43 subjects (91 implants) being available for evaluation of change in PPD. Group-2. All radiographs readable, giving 39 subjects (86 positions) for the evaluation.

Arm/Group Title	Group-1, Implant Length 6 mm	Group-2, Implant Length 11 mm
Arm/Group Description	Subjects treated with OsseoSpeed™ implant, length: 6 mm	Subjects treated with OsseoSpeed™ implant, length: 11 mm
Measure Participants	43	39
Measure implants	91	86
Mean (Standard Deviation) [millimeters]	-0.57 (0.92)	-1.11 (1.77)

5. Secondary Outcome

Title	Presence of Plaque
Description	Presence of plaque was evaluated at four surfaces around each study position (mesial, facial, distal and lingual). Plaque was recorded as presence or absence of plaque by visual inspection. A study position was considered as bleeding "yes" if at least one of the four surfaces around the implant showed presence of bleeding on probing.
Time Frame	Evaluated at the 5-year follow-up visit after loading.

Outcome Measure Data

Analysis Population Description

A total of 85 subjects (184 implants) completed the 5-year follow-up visit. All included in the assessment of presence of plaque.

Arm/Group Title	Group-1, Implant Length 6 mm	Group-2, Implant Length 11 mm
Arm/Group Description	Subjects treated with OsseoSpeed™ implant, length: 6 mm	Subjects treated with OsseoSpeed™ implant, length: 11 mm
Measure Participants	46	39
Measure implants	98	86
Count of Units [implants]	16	6

Adverse Events

Time Frame	5 years
Arm/Group Title	Group-1, Implant Length 6 mm		Group-2, Implant Length 11 mm
Arm/Group Description	Subjects treated with OsseoSpeed™ implant, length: 6 mm		Subjects treated with OsseoSpeed™ implant, length: 11 mm
All Cause Mortality
	Group-1, Implant Length 6 mm		Group-2, Implant Length 11 mm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Group-1, Implant Length 6 mm		Group-2, Implant Length 11 mm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	8/49 (16.3%)		5/46 (10.9%)
Cardiac disorders
Undefined heart problems	1/49 (2%)	1	0/46 (0%)	0
Eye disorders
Eye cancer (basal cell carcinoma)	0/49 (0%)	0	1/46 (2.2%)	2
General disorders
Death	0/49 (0%)	0	1/46 (2.2%)	1
Hepatobiliary disorders
Gallbladder removed	1/49 (2%)	1	0/46 (0%)	0
Liver cancer	0/49 (0%)	0	1/46 (2.2%)	1
Infections and infestations
Urinary tract infection	1/49 (2%)	1	0/46 (0%)	0
Right hip replacement, post-op infection	1/49 (2%)	1	0/46 (0%)	0
Armpit abscess due to spider bite.	1/49 (2%)	1	0/46 (0%)	0
Bilateral toe infection	1/49 (2%)	1	0/46 (0%)	0
Musculoskeletal and connective tissue disorders
Osteopaenia, trauma - fractured toes	1/49 (2%)	1	0/46 (0%)	0
Hip function failure	1/49 (2%)	2	0/46 (0%)	0
Broken pelvis	0/49 (0%)	0	1/46 (2.2%)	1
Hip fracture due to car accident	0/49 (0%)	0	1/46 (2.2%)	1
Product Issues
Failure knee-prosthesis	1/49 (2%)	1	0/46 (0%)	0
Renal and urinary disorders
Insufficient renal function (30%)	1/49 (2%)	1	0/46 (0%)	0
Reproductive system and breast disorders
Ovarian cancer	0/49 (0%)	0	1/46 (2.2%)	1
Respiratory, thoracic and mediastinal disorders
Pneumonitis - Non Hodgkin disease	0/49 (0%)	0	1/46 (2.2%)	1
Skin and subcutaneous tissue disorders
Squamous cell skin cancer	0/49 (0%)	0	1/46 (2.2%)	1
Vascular disorders
Arteriosclerosis	1/49 (2%)	1	0/46 (0%)	0
Other (Not Including Serious) Adverse Events
	Group-1, Implant Length 6 mm		Group-2, Implant Length 11 mm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	13/49 (26.5%)		12/46 (26.1%)
Product Issues
Study implant failure	5/49 (10.2%)	5	1/46 (2.2%)	1
Bridge screw loosening	5/49 (10.2%)	5	5/46 (10.9%)	10
Abutment fracture	1/49 (2%)	4	3/46 (6.5%)	3
Fracture of temporary bridge	2/49 (4.1%)	3	3/46 (6.5%)	3

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.