TM vs TSV Implants Loaded Early vs Conventional in Anterior and Posterior Areas

NCT02158377 | Completed

• 1 other identifier: CSU2011-08D
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 3

Brief Summary

Randomized-controlled, multicenter study of Trabecular Metal (TM) and Tapered Screw-Vent (TSV) dental implants loaded early in maxillary and mandibular sites.

Conditions

Partial Edentulism; Tooth Disease

Keywords

Dental implants; Trabecular Metal dental implants; TSV dental implants; Zimmer Dental; Implant stability; Implant stability quotient (ISQ); Resonance Frequency Analysis (RFA)

Outcome Measures

Primary Outcomes (1)

• Implant Stability

  Measure of Implant Stability Quotient immediately post implantation

  3-18 weeks

Secondary Outcomes (1)

• Marginal bone level change

  2 years

Study Arms (2)

Tapered Screw-vent implants (TSV)

ACTIVE COMPARATOR

TSV implants to replace missing tooth/teeth

Device: Tapered screw-vent implants (TSV)

Trabecular Metal dental implants (TM)

EXPERIMENTAL

TM dental implants to replace missing tooth/teeth

Device: Trabecular metal dental implants (TM)

Interventions

Trabecular metal dental implants (TM) DEVICE

Patients receive TM dental implants in this arm. The early stability is measured and compared to the stability of the TSV implants. The implants are loaded and provisionalized early at 3 or 6 weeks if stability permits.

Trabecular Metal dental implants (TM)

Tapered screw-vent implants (TSV) DEVICE

Patients receive TSV dental implants in this arm. The early stability is measured and compared to the stability of the TM implants. The implants are loaded and provisionalized early at 3 or 6 weeks if stability permits.

Tapered Screw-vent implants (TSV)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Benefit from the implant and restoration
• Provide a voluntarily signed Informed Consent
• Must be 18 years or older
• Have one or more edentulous area(s) in the posterior maxilla or mandible designated for an implant supported restoration
• The implantation site must have a functional antagonist to obtain full occlusion.
• Implants adjacent to planned site of implantation should have been in function for at least 1 year.
• The site intended for implant placement should have healed for at least 4 months from the time of extraction or at least 6 months from any other bone augmentation procedures.
• The site intended for implant placement should have adequate bone volume to support an implant without the need for augmentation except for minor dehiscence (limited to a vertical height of 2mm), which can be augmented with autogenous bone chips to improve soft tissue attachment.
• The site intended for implant placement should have residual facial and palatal/lingual plates to be at least 1.0mm thick after implant placement.
• The site intended for implant placement should have vertical bone volume to extend at least 2.0mm apical to the implant after implant placement.

You may not qualify if:

• Subjects mentally incompetent or unable to understand and provide an Informed Consent
• Smokers, alcoholics or drug abusers
• Subjects with systemic conditions such as uncontrolled diabetes, endocrine disorders, heart disease, immune-compromised subjects or mental disorders
• Use of concurrent medication which inhibits bone metabolism like bisphosphonates, corticosteroids or methotrexate
• Bleeding disorders and/or anticoagulant therapy
• Pregnancy
• Known sensitivity or allergy to any of the implant materials
• Subjects with bruxism or clenching habits
• Uncontrolled periodontal or oral pathologies (e.g. mucosal disease, oral lesions)
• Inadequate oral hygiene
• History of radiation at the site intended for study implant placement
• Subjects who have previously failed dental implants at the site intended for study implant placement
• Subjects participating in another clinical study
• Subjects who need other surgeries in a site adjacent to the study implant(s)
• Subjects who need other surgeries in a site non-adjacent to the study implant(s) within 6 months of study implant placement

Sponsors & Collaborators

• ZimVie: lead

Study Sites (3)

Universitat Regensburg

Regensburg, Bavaria, 93053, Germany

Location

Heinrich Heine Universitat Dusseldorf

Düsseldorf, Nordhein-Westfalen, 40225, Germany

Location

Universitatsmedizin Mainz

Mainz, Rhineland-Palatinate, 55131, Germany

Location

MeSH Terms

Conditions

Tooth Diseases

Condition Hierarchy (Ancestors)

Stomatognathic Diseases

Study Officials

• Wilfried Wagner

  Universitatsbedizin Mainz

  PRINCIPAL INVESTIGATOR

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: June 4, 2014
• First Posted: June 6, 2014
• Study Start: March 1, 2013
• Primary Completion: June 1, 2019
• Study Completion: July 1, 2020
• Last Updated: March 29, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (3)