CompletedNCT00646113Updated Nov 18, 2019Results posted

Study Evaluating OsseoSpeed™ Narrow Implant in the Upper and Lower Anterior Jaw

An interventional study of OsseoSpeed™ TX 3.0S in Jaw, Edentulous, Partially, sponsored by Dentsply Sirona Implants and Consumables. Completed at 6 sites in 6 countries. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-11-18.

Sponsored by Dentsply Sirona Implants and Consumables · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 72
Allocation: Not applicable
Ages: 18 Years to 70 Years
Sex: All

Study summary

To evaluate 5-year survival, functionality and safety for OsseoSpeed™ 3.0 mm diameter implant when used for single tooth crown in positions 12, 22, 31, 32, 41 and 42. The primary hypothesis is that implant survival after 5 years is equal to what has been observed with comparable implants in current literature.

Conditions studied

Jaw, Edentulous, Partially

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In context

Jaw, Edentulous

171 studies on the registry are indexed under Jaw, Edentulous; 24 are open to participants now.

This study's enrollment of 72 is above the median of 33 across 146 interventional studies indexed under Jaw, Edentulous.

Browse Jaw, Edentulous studies →

Lead sponsor

Dentsply Sirona Implants and Consumables is the lead sponsor of 35 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 70 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Provision of informed consent
Aged 18-70 years at enrolment
History of edentulism in the study area of at least two months
Presence of natural tooth roots adjacent to the study implant position
Deemed by the investigator to have a bone height and width suitable for 3.0 mm diameter study implant
Deemed by the investigator as likely to present an initially stable implant situation

Exclusion criteria

Exclusion Criteria:

Unlikely to be able to comply with study procedures, as judged by the investigator
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, as deemed by the investigator
Uncontrolled diabetes mellitus
Corticosteroids or any other medication that could influence post-operative healing and/or osseointegration
Smoking more than 10 cigarettes per 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
Simultaneous participation in another clinical study, or participation in a clinical study during the last weeks prior to enrolment

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 72 participants (actual)

Study arms

Experimental
OsseoSpeed™ TX 3.0S (Dental implant)
OsseoSpeed™ TX 3.0S, Dental implants, 3.0 mm diameter, in lengths of 11, 13 and 15 mm
Device: OsseoSpeed™ TX 3.0S

Interventions

DeviceOsseoSpeed™ TX 3.0S
OsseoSpeed™ TX 3.0 mm diameter

What researchers measure

Primary outcomes

Implant Survival Rate
Overall implant survival rate evaluated clinically and radiographically
Time frame: Evaluated at implant placement and at the 5 years follow-up after implant placement

Results

Posted Oct 1, 2019

Participant flow

Participant flow — Overall Study
Milestone	OsseoSpeed™ TX 3.0
Started	69
Completed	61
Not completed	8
Withdrew: Lost to follow-up	5
Withdrew: Adverse event	3

Outcome measures

PrimaryImplant Survival Rate

Overall implant survival rate evaluated clinically and radiographically

Time frame:: Evaluated at implant placement and at the 5 years follow-up after implant placement
Reported as:: Count of units · Implants

Implant Survival Rate
Implants	OsseoSpeed™
Implant Survival Rate	93

Adverse events

Collected over 5 years. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
OsseoSpeed™ TX 3.0S	—	0/69 (0%)	39/69 (56.5%)

Most frequent other events

Most frequent other events
Event	OsseoSpeed™ TX 3.0S
Common coldInfections and infestations	14/69
Crown lossProduct Issues	10/69
Abutment fracturesProduct Issues	7/69
Implant lostProduct Issues	4/69
HeadacheGeneral disorders	4/69

Baseline characteristics

Number of enrolled participants that completed surgery (Baseline)

Age, Continuous
Age, Continuous(years)	OsseoSpeed™ TX 3.0S
Mean	32.5 ± 15.11

Sex: Female, Male
Sex: Female, Male(Participants)	OsseoSpeed™ TX 3.0S
Female	33
Male	36

Region of Enrollment
Region of Enrollment(participants)	OsseoSpeed™ TX 3.0S
Sweden	15
Denmark	14
United Kingdom	12
Italy	10
Germany	4
Spain	14

Study locations

6 sites

Tand-mund-kaebekirurgisk Klinik
Copenhagen, 2100, Denmark
Bundeswehrkrankenhaus
Ulm, D-89081, Germany
Clinica Odontoiatrica
Milano, 20123, Italy
Department Oral Surgery, University of Granada: School of Dentistry
Granada, 18071, Spain
Käkkirurgiska kliniken, Odontologiska Institutionen
Jönköping, 551 11, Sweden
Bristol Dental Hospital and School
Bristol, BS1 2LY, United Kingdom

References and documents

Publications

Galindo-Moreno P, Nilsson P, King P, Becktor J, Speroni S, Schramm A, Maiorana C. Clinical and radiographic evaluation of early loaded narrow diameter implants - 1-year follow-up. Clin Oral Implants Res. 2012 May;23(5):609-16. doi: 10.1111/j.1600-0501.2011.02254.x. Epub 2011 Sep 28. PubMed 22093047 ↗
Maiorana C, King P, Quaas S, Sondell K, Worsaae N, Galindo-Moreno P. Clinical and radiographic evaluation of early loaded narrow-diameter implants: 3 years follow-up. Clin Oral Implants Res. 2015;26(1):77-82. doi: 10.1111/clr.12281. Epub 2013 Oct 30. PubMed 25650268 ↗
King P, Maiorana C, Luthardt RG, Sondell K, Oland J, Galindo-Moreno P, Nilsson P. Clinical and Radiographic Evaluation of a Small-Diameter Dental Implant Used for the Restoration of Patients with Permanent Tooth Agenesis (Hypodontia) in the Maxillary Lateral Incisor and Mandibular Incisor Regions: A 36-Month Follow-Up. Int J Prosthodont. 2016 Mar-Apr;29(2):147-53. doi: 10.11607/ijp.4444. PubMed 26929953 ↗
Galindo-Moreno P, Nilsson P, King P, Worsaae N, Schramm A, Padial-Molina M, Maiorana C. Clinical and radiographic evaluation of early loaded narrow-diameter implants: 5-year follow-up of a multicenter prospective clinical study. Clin Oral Implants Res. 2017 Dec;28(12):1584-1591. doi: 10.1111/clr.13029. Epub 2017 Jun 18. PubMed 28626888 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 18, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00646113
Lead sponsor: Dentsply Sirona Implants and Consumables
Responsible party: Sponsor
First posted: Mar 28, 2008
Start date: Mar 2008
Primary completion: Aug 2014
Completion: Aug 2014
Results posted: Oct 1, 2019
Last update: Nov 18, 2019

Study contacts

Pablo Galindo Moreno, Assoc. Prof.

principal investigator · University of Granada: School of Dentistry

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.

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