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

NCT ID: NCT02158377

Last Updated: 2022-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2020-07-31

Brief Summary

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

Detailed Description

This is a randomized, controlled, multicenter study to assess and compare implant stability of Trabecular Metal (TM) dental implants and Tapered Screw-Vent (TSV) implants during the early stages of healing i.e. 21 +/- 2 days and 42+/- 2 days, as well as their short term clinical outcomes.

Conditions

Partial Edentulism; Tooth Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tapered Screw-vent implants (TSV)

TSV implants to replace missing tooth/teeth

Group Type: ACTIVE_COMPARATOR

Tapered screw-vent implants (TSV)

Intervention Type: 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.

Trabecular Metal dental implants (TM)

TM dental implants to replace missing tooth/teeth

Group Type: EXPERIMENTAL

Trabecular metal dental implants (TM)

Intervention Type: 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.

Interventions

Trabecular metal dental implants (TM)

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.

Intervention Type: DEVICE

Tapered screw-vent implants (TSV)

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Benefit from the implant and restoration

2. Provide a voluntarily signed Informed Consent

3. Must be 18 years or older

4. Have one or more edentulous area(s) in the posterior maxilla or mandible designated for an implant supported restoration

5. The implantation site must have a functional antagonist to obtain full occlusion.

6. Implants adjacent to planned site of implantation should have been in function for at least 1 year.

7. 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.

8. 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.

9. The site intended for implant placement should have residual facial and palatal/lingual plates to be at least 1.0mm thick after implant placement.

10. The site intended for implant placement should have vertical bone volume to extend at least 2.0mm apical to the implant after implant placement.

Exclusion Criteria

1. Subjects mentally incompetent or unable to understand and provide an Informed Consent

2. Smokers, alcoholics or drug abusers

3. Subjects with systemic conditions such as uncontrolled diabetes, endocrine disorders, heart disease, immune-compromised subjects or mental disorders

4. Use of concurrent medication which inhibits bone metabolism like bisphosphonates, corticosteroids or methotrexate

5. Bleeding disorders and/or anticoagulant therapy

6. Pregnancy

7. Known sensitivity or allergy to any of the implant materials

8. Subjects with bruxism or clenching habits

9. Uncontrolled periodontal or oral pathologies (e.g. mucosal disease, oral lesions)

10. Inadequate oral hygiene

11. History of radiation at the site intended for study implant placement

12. Subjects who have previously failed dental implants at the site intended for study implant placement

13. Subjects participating in another clinical study

14. Subjects who need other surgeries in a site adjacent to the study implant(s)

15. Subjects who need other surgeries in a site non-adjacent to the study implant(s) within 6 months of study implant placement

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

ZimVie

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wilfried Wagner

Role: PRINCIPAL_INVESTIGATOR

Universitatsbedizin Mainz

Locations

Universitat Regensburg

Regensburg, Bavaria, Germany

Heinrich Heine Universitat Dusseldorf

Düsseldorf, Nordhein-Westfalen, Germany

Universitatsmedizin Mainz

Mainz, Rhineland-Palatinate, Germany

Countries

Germany

Other Identifiers

CSU2011-08D

Identifier Type: -

Identifier Source: org_study_id