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

Partial Edentulism Clinical Trial

— TMEL  

Official title:

A Randomized Controlled Multicenter Study of Trabecular Metal Dental Implants vs.Tapered Screw-Vent Dental Implants Loaded Early vs. Conventionally in the Maxilla and Mandible.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02158377
• Other study ID #: CSU2011-08D
• Status: Completed
• Phase: N/A
• Start date: March 2013
• Est. completion date: July 2020

Study information

• Verified date: March 2022
• Source: ZimVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: July 2020
• Est. primary completion date: June 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Partial Edentulism
• Tooth Disease
• Tooth Diseases

Intervention

Device:
• 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.
• 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.

Locations

Country	Name	City	State
Germany	Heinrich Heine Universitat Dusseldorf	Dusseldorf	Nordhein-Westfalen
Germany	Universitatsmedizin Mainz	Mainz	Rheinland-Pfalz
Germany	Universitat Regensburg	Regensburg	Bayern

Sponsors (1)

Lead Sponsor	Collaborator
ZimVie

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implant Stability	Measure of Implant Stability Quotient immediately post implantation	3-18 weeks
Secondary	Marginal bone level change	Measurement of bone level surrounding implant	2 years