Study Comparing Appearance and Function of Three Different Dental Implant Designs When Placed in Front Region of Upper Jaw

• Sponsor: Dentsply Sirona Implants (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00820235
• Collaborator: (none)
• Enrollment: 141
• Locations: 4
• Arms: 3
• Actual Duration (Months): 91
• Patients Per Site: 35.3
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

The primary objective is to compare the gum response to three different dental implant designs when placed in the front region of the upper jaw. The changes from baseline to one year after will be compared. The null-hypothesis is that the buccal soft tissue (gum) changes from baseline to one year after are equal for all three implant-abutment interface settings.

Condition or Disease	Intervention/Treatment	Phase
Jaw, Edentulous, Partially	Device: OsseoSpeed™; Device: NobelSpeedy™ Replace®; Device: NanoTite™ Certain® PREVAIL®	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 141 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Prospective, Comparative Assessment of Single-tooth Replacement in Different Implant-abutment Settings
• Actual Study Start Date: Feb 1, 2009
• Actual Primary Completion Date: Sep 1, 2016
• Actual Study Completion Date: Sep 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A	Device: OsseoSpeed™; OsseoSpeed™ implant
Active Comparator: B	Device: NobelSpeedy™ Replace®; NobelSpeedy™ Replace® implant
Active Comparator: C	Device: NanoTite™ Certain® PREVAIL®; NanoTite™ Certain® PREVAIL® implant

Outcome Measures

Primary Outcome Measures

1. Buccal Soft Tissue (Gum) Changes, Measured as Mid-buccal Gingival Zenith (GZ) Scores. [Evaluated at time of loading (permanent restoration) and at the 5-years follow-up after loading]

   Soft tissue response was evaluated by measuring it clinically and by evaluating it from clinical photographs using image analysis. Clinical evaluations of gingival zenith were performed at time of loading (permanent restoration) and at the 5-year follow-up after loading. The vertical distance from the most apical aspect of the soft tissue margin to the incisal edge of implant crown was measured using a standardized periodontal probe to the nearest half millimeter using the surgical loupe. The changes in the gingival zenith was calculated for each study position and the average for each treatment group was calculated for the evaluation period.

Secondary Outcome Measures

1. Marginal Bone Level Alterations [Evaluated at time of implant installation and at the 5-year follow-up visit.]

   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 time of implant placement.

2. Evaluation of the Periimplant Mucosa Condition - By Assessment of PPD [Measured at time of loading of permanent restoration and at the 5-year follow-up.]

   Condition of the periimplant mucosa by assessment of 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.

3. Evaluation of the Periimplant Mucosa Condition - By Assessment of Change in BoP. [Measured at the implant loading and at the 5-year follow-up after loading.]

   Condition of the periimplant mucosa by assessment of Bleeding on Probing (BoP). Presented as change in proportion of surfaces that show presence of BoP, measured from implant loading to the 5-year follow-up visit.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Provision of informed consent

• At least 18 years

• In need of one or more single implants replacing missing or non-restorable teeth in the maxilla within region 14 to 24

The following should be considered at inclusion but can not be fulfilled until at Visit 2:

• Edentulous for at least 5 months at study site

• A buccal-lingual bone width at study site of at least 5.5 mm

• A mesial-distal bone level distance between adjacent teeth at study site of at least 5.5 mm

• A keratinized mid-buccal mucosal height of at least 2 mm at study site

• Teeth adjacent (mesial and distal) to study site must consist of two stable teeth on natural roots without signs of periodontal bone loss (>1 mm) and/or significant soft tissue loss

• Teeth adjacent (mesial and distal) to study site must demonstrate a stable occlusal guidance that will allow non-functional disclusion in all eccentric positions

• An opposing dentition with teeth, implants or prosthesis

Exclusion Criteria:

• Insufficient interocclusal distance for implant placement and restoration at study site

• Tooth adjacent (mesial and/or distal) to study site is ankylosed

• More than 2 mm vertical bone loss at study site as measured from the mid-buccal crest of bone on the adjacent teeth

• Site development (bone tissue) performed at less than 5 months before Visit 2 at study site

• Untreated rampant caries and/or uncontrolled periodontal disease

• Class II division 2 malocclusion (Edward Hartley Angle)

• Use of tobacco within last 6 months

• Uncontrolled diabetes (subjects history does not reveal the absence of control of insulin-dependent/non-insulin dependent Diabetes Mellitus)

• Current alcohol or drug abuse

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

• Use of any substance that will influence bone metabolism

• Need for systemic corticosteroids or any other medication that would influence post-operative healing and/or osseointegration

• History of radiation in the head and neck region

• Known pregnancy, pregnancy tests will be performed as per local requirements.

• Unable or unwilling to return for follow-up visits for a period of 5 years

• Unlikely to be able to comply with study procedures according to Investigators judgement

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

• Previous enrollment or randomization of treatment in the present study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Iowa, College of Dentistry	Iowa City	Iowa	United States	52242-1010
2	University of North Carolina, School of Dentistry	Chapel Hill	North Carolina	United States	27599-7450
3	Perio Health Clinical Research Center	Houston	Texas	United States	77063
4	Faculty of Dentistry, McGill University	Montreal	Quebec	Canada	H3A 2K6

Sponsors and Collaborators

• Dentsply Sirona Implants

Investigators

• Study Director: Lyndon Cooper, Prof., University of Illinois College of Dentistry

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dentsply Sirona Implants
• ClinicalTrials.gov Identifier: NCT00820235
• Other Study ID Numbers: YA-OSS-0003
• First Posted: Jan 12, 2009
• Last Update Posted: May 7, 2020
• Last Verified: Apr 1, 2020

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

Study Results

Participant Flow

Arm/Group Title	Group-A. OsseoSpeed™ Implant	Group-B. NobelSpeedy™ Replace® Implant	Group-C. NanoTite™ Certain® PREVAIL® Implant
Arm/Group Description	Subjects that had OsseoSpeed™ implants installed.	Subjects that had NobelSpeedy™ Replace® implants installed	Subjects that had NanoTite™ Certain® PREVAIL® implants installed
Period Title: Overall Study
STARTED	48	49	44
COMPLETED	33	28	27
NOT COMPLETED	15	21	17

Baseline Characteristics

Arm/Group Title	Group-A. OsseoSpeed™ Implant	Group-B. NobelSpeedy™ Replace® Implant	Group-C. NanoTite™ Certain® PREVAIL® Implant	Total
Arm/Group Description	Subjects that had OsseoSpeed™ implants installed.	Subjects that had NobelSpeedy™ Replace® implants installed	Subjects that had NanoTite™ Certain® PREVAIL® implants installed	Total of all reporting groups
Overall Participants	48	49	44	141
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	43 (15)	46 (17)	46 (16)	45 (16)
Sex: Female, Male (Count of Participants)
Female	23 47.9%	35 71.4%	22 50%	80 56.7%
Male	25 52.1%	14 28.6%	22 50%	61 43.3%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%
Asian	2 4.2%	1 2%	1 2.3%	4 2.8%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	3 6.3%	2 4.1%	5 11.4%	10 7.1%
White	42 87.5%	46 93.9%	36 81.8%	124 87.9%
More than one race	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	1 2.1%	0 0%	2 4.5%	3 2.1%
Region of Enrollment (participants) [Number]
Canada	10 20.8%	9 18.4%	7 15.9%	26 18.4%
United States	38 79.2%	40 81.6%	37 84.1%	115 81.6%

Outcome Measures

1. Primary Outcome

Title	Buccal Soft Tissue (Gum) Changes, Measured as Mid-buccal Gingival Zenith (GZ) Scores.
Description	Soft tissue response was evaluated by measuring it clinically and by evaluating it from clinical photographs using image analysis. Clinical evaluations of gingival zenith were performed at time of loading (permanent restoration) and at the 5-year follow-up after loading. The vertical distance from the most apical aspect of the soft tissue margin to the incisal edge of implant crown was measured using a standardized periodontal probe to the nearest half millimeter using the surgical loupe. The changes in the gingival zenith was calculated for each study position and the average for each treatment group was calculated for the evaluation period.
Time Frame	Evaluated at time of loading (permanent restoration) and at the 5-years follow-up after loading

Outcome Measure Data

Analysis Population Description

A total of 88 subjects completed the 5-year follow-up visit. Five radiographs (two in group A, two in group B and one in group C) were not possible to evaluate, giving an overall number of 83 subjects (83 implants) as basis for the analysis of Gingival Zenith score change.

Arm/Group Title	Group-A. OsseoSpeed™ Implant	Group-B. NobelSpeedy™ Replace® Implant	Group-C. NanoTite™ Certain® PREVAIL® Implant
Arm/Group Description	Subjects that had OsseoSpeed™ implants installed.	Subjects that had NobelSpeedy™ Replace® implants installed	Subjects that had NanoTite™ Certain® PREVAIL® implants installed
Measure Participants	31	26	26
Measure Implants	31	26	26
Mean (Standard Deviation) [Millimeter]	0.08 (0.65)	-0.10 (1.00)	0.00 (0.58)

2. Secondary Outcome

Title	Marginal Bone Level Alterations
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 time of implant placement.
Time Frame	Evaluated at time of implant installation and at the 5-year follow-up visit.

Outcome Measure Data

Analysis Population Description

A total of 88 subjects completed the 5-year follow-up visit. Three radiographs (all in group C) were not possible to evaluate, giving an overall number of 85 subjects (85 implants) as basis for the analysis of marginal bone level change.

Arm/Group Title	Group-A. OsseoSpeed™ Implant	Group-B. NobelSpeedy™ Replace® Implant	Group-C. NanoTite™ Certain® PREVAIL® Implant
Arm/Group Description	Subjects that had OsseoSpeed™ implants installed.	Subjects that had NobelSpeedy™ Replace® implants installed	Subjects that had NanoTite™ Certain® PREVAIL® implants installed
Measure Participants	33	28	24
Mean (Standard Deviation) [Millimeter]	-0.16 (0.45)	-0.92 (0.70)	-0.81 (1.06)

3. Secondary Outcome

Title	Evaluation of the Periimplant Mucosa Condition - By Assessment of PPD
Description	Condition of the periimplant mucosa by assessment of 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	Measured at time of loading of permanent restoration and at the 5-year follow-up.

Outcome Measure Data

Analysis Population Description

A total of 88 subjects completed the 5-year follow-up visit. All those subjects are included in the PPD assessment.

Arm/Group Title	Group-A. OsseoSpeed™ Implant	Group-B. NobelSpeedy™ Replace® Implant	Group-C. NanoTite™ Certain® PREVAIL® Implant
Arm/Group Description	Subjects that had OsseoSpeed™ implants installed.	Subjects that had NobelSpeedy™ Replace® implants installed	Subjects that had NanoTite™ Certain® PREVAIL® implants installed
Measure Participants	33	28	27
Mean (Standard Deviation) [Millimeter]	0.08 (0.88)	-0.06 (0.88)	-0.09 (0.57)

4. Secondary Outcome

Title	Evaluation of the Periimplant Mucosa Condition - By Assessment of Change in BoP.
Description	Condition of the periimplant mucosa by assessment of Bleeding on Probing (BoP). Presented as change in proportion of surfaces that show presence of BoP, measured from implant loading to the 5-year follow-up visit.
Time Frame	Measured at the implant loading and at the 5-year follow-up after loading.

Outcome Measure Data

Analysis Population Description

A total of 88 subjects completed the 5-year follow-up visit. All those subjects are included in the assessment of BoP change.

Arm/Group Title	Group-A. OsseoSpeed™ Implant	Group-B. NobelSpeedy™ Replace® Implant	Group-C. NanoTite™ Certain® PREVAIL® Implant
Arm/Group Description	Subjects that had OsseoSpeed™ implants installed.	Subjects that had NobelSpeedy™ Replace® implants installed	Subjects that had NanoTite™ Certain® PREVAIL® implants installed
Measure Participants	33	28	27
Measure Surfaces	33	28	27
Mean (Standard Deviation) [Change in proportion of surfaces]	0.13 (0.38)	0.04 (0.34)	0.07 (0.33)

Adverse Events

Time Frame	5 years
Arm/Group Title	Group-A. OsseoSpeed™ Implant		Group-B. NobelSpeedy™ Replace® Implant		Group-C. NanoTite™ Certain® PREVAIL® Implant
Arm/Group Description	Subjects that had OsseoSpeed™ implants installed.		Subjects that had NobelSpeedy™ Replace® implants installed		Subjects that had NanoTite™ Certain® PREVAIL® implants installed
All Cause Mortality
	Group-A. OsseoSpeed™ Implant		Group-B. NobelSpeedy™ Replace® Implant		Group-C. NanoTite™ Certain® PREVAIL® Implant
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Group-A. OsseoSpeed™ Implant		Group-B. NobelSpeedy™ Replace® Implant		Group-C. NanoTite™ Certain® PREVAIL® Implant
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	8/48 (16.7%)		3/49 (6.1%)		8/44 (18.2%)
Cardiac disorders
Hospitalized for follow-up on chest pains	1/48 (2.1%)	1	0/49 (0%)	0	1/44 (2.3%)	1
Hospitalization after heart attack	1/48 (2.1%)	1	0/49 (0%)	0	1/44 (2.3%)	1
Death caused by heart attack	1/48 (2.1%)	1	0/49 (0%)	0	0/44 (0%)	0
Gastrointestinal disorders
Hospitalized for gastric surgery	0/48 (0%)	0	0/49 (0%)	0	1/44 (2.3%)	1
Hospitalized for surgery of infected appendix	1/48 (2.1%)	1	0/49 (0%)	0	0/44 (0%)	0
Colon cancer	0/48 (0%)	0	0/49 (0%)	0	1/44 (2.3%)	1
Hepatobiliary disorders
Hospitalised for gall bladder surgery	1/48 (2.1%)	1	0/49 (0%)	0	0/44 (0%)	0
Infections and infestations
Hospitalized due to fever after mastectomy	0/48 (0%)	0	1/49 (2%)	1	0/44 (0%)	0
Hospitalized for treatment of infection after vaccination	1/48 (2.1%)	1	0/49 (0%)	0	0/44 (0%)	0
Musculoskeletal and connective tissue disorders
Hospitalized for spine fusion surgery	0/48 (0%)	0	0/49 (0%)	0	1/44 (2.3%)	1
Hospitalized for knee replacement	1/48 (2.1%)	1	0/49 (0%)	0	0/44 (0%)	0
Hospitalized for fractured leg after an accident	0/48 (0%)	0	0/49 (0%)	0	1/44 (2.3%)	1
Psychiatric disorders
Hospitalized due to episode of bi-polar disorder	0/48 (0%)	0	0/49 (0%)	0	1/44 (2.3%)	1
Renal and urinary disorders
Hospitalized for partial nephrectomy	0/48 (0%)	0	1/49 (2%)	1	0/44 (0%)	0
Reproductive system and breast disorders
Breast cancer	0/48 (0%)	0	1/49 (2%)	1	0/44 (0%)	0
Hospitalized due to menstrual hemorrhage	0/48 (0%)	0	1/49 (2%)	1	0/44 (0%)	0
Respiratory, thoracic and mediastinal disorders
Hospitalized due to pneumonia	0/48 (0%)	0	0/49 (0%)	0	1/44 (2.3%)	1
Skin and subcutaneous tissue disorders
Basal cell carcinoma	1/48 (2.1%)	1	0/49 (0%)	0	0/44 (0%)	0
Vascular disorders
Hospitalization due to hypertension	0/48 (0%)	0	0/49 (0%)	0	1/44 (2.3%)	1
Other (Not Including Serious) Adverse Events
	Group-A. OsseoSpeed™ Implant		Group-B. NobelSpeedy™ Replace® Implant		Group-C. NanoTite™ Certain® PREVAIL® Implant
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	8/48 (16.7%)		23/49 (46.9%)		10/44 (22.7%)
General disorders
Other	1/48 (2.1%)	1	9/49 (18.4%)	9	2/44 (4.5%)	2
Musculoskeletal and connective tissue disorders
Study implant failled to osseointegrate	0/48 (0%)	0	8/49 (16.3%)	8	6/44 (13.6%)	6
Study implant temporary mobile	0/48 (0%)	0	0/49 (0%)	0	3/44 (6.8%)	3
Product Issues
Restoration failure	6/48 (12.5%)	6	8/49 (16.3%)	8	1/44 (2.3%)	1
Loose abutments	3/48 (6.3%)	3	2/49 (4.1%)	2	0/44 (0%)	0

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.