An Evaluation of Integration Success and Maintenance of Short Implants in Maxillas Needing Sinus Augmentation

NCT00725049 | Completed Results DMC

• 1 other identifier: 2611
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective randomized study will evaluate the integration success while supporting a prosthesis for short implants placed into maxillary sites having minimal bone height that would otherwise need sinus augmentation. The resources utilized during treatment will be assessed. Study (null) hypothesis: the overall benefit of using short length implants to avoid sinus augmentation procedures will offset differences in the cumulative implant survival rates observed between treatment groups.

Conditions

Tooth Disease; Partial Edentulism

Keywords

dental implants; Nanotite Certain implant; Osseotite; multicenter; randomized; clinical study; partial edentulism; crestal bone level; short fixed bridge; cost analysis

Outcome Measures

Primary Outcomes (1)

• Integration Success of Implant

  Number of enrolled and treated patients with integrated implants (no mobility detected) at time of analysis.

  3 years

Study Arms (2)

Dental implant (Nanotite)

ACTIVE COMPARATOR

Dental implants of short length placed without sinus lifts

Device: Dental Implant (Nanotite)

Control group

NO INTERVENTION

Dental implants of standard length placed simultaneously with sinus augmentation

Interventions

Dental Implant (Nanotite) DEVICE

Root form titanium dental implant

Also known as: Nanotite

Dental implant (Nanotite)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients of either sex and any race greater than 18 years of age
• patients with partial edentulism in the posterior maxilla requiring a unilateral implant-supported maxillary prosthesis
• patients with a residual alveolar floor of the sinus between 4 and 6 mm in height, as assessed on intraoral radiographs, and able to receive at least a 4mm wide implant
• patients must be physically able to tolerate conventional surgical and restorative procedures

You may not qualify if:

• patients with active infection or severe inflammation in the areas intended for implant placement
• patients with a \> 10 cigarettes per day smoking habit
• patients with uncontrolled diabetes or metabolic bone disease
• patient with a history of therapeutic radiation to the head
• patients who are known to be pregnant
• patients with para-functional habits with evidence of severe bruxing or clenching
• patients not able to commit to a 3 year follow-up program

Sponsors & Collaborators

• ZimVie: lead

Study Sites (1)

Universidad Complutense de Madrid

Madrid, 28040, Spain

Location

MeSH Terms

Conditions

Tooth Diseases

Interventions

Dental Implants

Condition Hierarchy (Ancestors)

Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Materials; Biomedical and Dental Materials; Dental Prosthesis; Prosthodontics; Dentistry; Prostheses and Implants; Equipment and Supplies; Manufactured Materials; Technology, Industry, and Agriculture

Results Point of Contact

• Title: Clinical Research Manager
• Organization: Biomet 3i LLC

cristina.matthews@biomet.com

5617766722

Study Officials

• Mariano A Sanz, MD, DDS

  Universidad Complutense de Madrid

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2008
• First Posted: July 30, 2008
• Study Start: February 1, 2009
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: February 20, 2024
• Results First Posted: October 11, 2013

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)