Study of Bone Preservation When OsseoSpeed™ Implants Are Placed Immediately Following Tooth Extraction

Jaw, Edentulous, Partially Clinical Trial

Official title:

A Prospective, Randomized, Controlled Study to Evaluate Buccal Bone Preservation Using Fixture MicroThread™ OsseoSpeed™ Placed in Fresh Extraction Sockets the Maxilla.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00711282
• Other study ID #: YA-OSS-0009
• Status: Completed
• Phase: N/A
• Start date: December 2005
• Est. completion date: June 14, 2011

Study information

• Verified date: February 2023
• Source: Dentsply Sirona Implants and Consumables
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the clinical performance of implants placed in individuals who are about to loose one or more of their upper teeth. The main objective is to study how the surrounding bone tissue reacts to two different shapes of implants. Clinical performance, in wider terms, means esthetics and long lasting function. Half of the patients will receive a cylindrically shaped implant and the other half will receive a conical-cylindrical implant. The implants will be placed and after a healing period of 16 weeks the gum will be re-opened and the bone tissue response clinically evaluated. Permanent artificial tooth/teeth will be attached six weeks after that.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: June 14, 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Provision of written informed consent

• At least 18 years at inclusion

• At least 20 teeth with expected functional balanced occlusion after restoration

• In need of one or more implants replacing teeth to be removed in the maxilla within region 15 to 25

• Presence of an intact extraction socket following removal of the natural tooth defined by: (1) a situation where the marginal border of the facial bone crest deviates less than or equal to 2 mm from that of the expected normal anatomy of the site/region, (2) a marginal border of a potential facial fenestration at least 3 mm apical of the marginal bone crest

• Presence of an extraction socket anatomy, following removal of the natural tooth, suitable for both cylindrical and conical/cylindrical implants

Exclusion Criteria:

• Untreated rampant caries and uncontrolled periodontal disease

• Absence of adjacent (mesial and/or distal) natural tooth root

• 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

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

• History of radiation in the head and neck region

• History of chemotherapy within 5 years prior to surgery

• Unable or unwilling to return for follow-up visits for a period of 3 years and 6 months

• Unrealistic esthetic demands

• 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 investigational site)

• Previous enrolment in this study

Related Conditions & MeSH terms

• Jaw, Edentulous
• Jaw, Edentulous, Partially

Intervention

Device:
• OsseoSpeed™
OsseoSpeed™ MicroThread™, diameters of 3.5 and 4.0 mm.
• OsseoSpeed™
OsseoSpeed™ MicroThread™, diameters of 4.5 and 5.0 mm.

Locations

Country	Name	City	State
Italy	Studio Odontoiatrico	Padova
Spain	Department of Periodontics, Faculty of Odontology, Universidad Complutense de Madrid	Madrid
Switzerland	Department of Periodontology, School of Dental Medicine, University of Berne	Berne

Sponsors (1)

Lead Sponsor	Collaborator
Dentsply Sirona Implants and Consumables

Countries where clinical trial is conducted

Italy,  Spain,  Switzerland, 

References & Publications (6)

Cecchinato D, Lops D, Salvi GE, Sanz M. A prospective, randomized, controlled study using OsseoSpeed implants placed in maxillary fresh extraction socket: soft tissues response. Clin Oral Implants Res. 2015;26(1):20-7. doi: 10.1111/clr.12295. Epub 2013 De — View Citation

Ferrus J, Cecchinato D, Pjetursson EB, Lang NP, Sanz M, Lindhe J. Factors influencing ridge alterations following immediate implant placement into extraction sockets. Clin Oral Implants Res. 2010 Jan;21(1):22-9. doi: 10.1111/j.1600-0501.2009.01825.x. Epub — View Citation

Huynh-Ba G, Pjetursson BE, Sanz M, Cecchinato D, Ferrus J, Lindhe J, Lang NP. Analysis of the socket bone wall dimensions in the upper maxilla in relation to immediate implant placement. Clin Oral Implants Res. 2010 Jan;21(1):37-42. doi: 10.1111/j.1600-05 — View Citation

Sanz M, Cecchinato D, Ferrus J, Pjetursson EB, Lang NP, Lindhe J. A prospective, randomized-controlled clinical trial to evaluate bone preservation using implants with different geometry placed into extraction sockets in the maxilla. Clin Oral Implants Re — View Citation

Sanz M, Cecchinato D, Ferrus J, Salvi GE, Ramseier C, Lang NP, Lindhe J. Implants placed in fresh extraction sockets in the maxilla: clinical and radiographic outcomes from a 3-year follow-up examination. Clin Oral Implants Res. 2014 Mar;25(3):321-327. do — View Citation

Tomasi C, Sanz M, Cecchinato D, Pjetursson B, Ferrus J, Lang NP, Lindhe J. Bone dimensional variations at implants placed in fresh extraction sockets: a multilevel multivariate analysis. Clin Oral Implants Res. 2010 Jan;21(1):30-6. doi: 10.1111/j.1600-050 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical measure of the thickness of the facial bone wall.		At implant placement and after 16 weeks of healing.