Clinical trial NCT02158377: TM vs TSV Implants Loaded Early vs Conventional in Anterior and Posterior Areas
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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)
Lead sponsor: ZimVie
Sponsor class: INDUSTRY
First posted: 2014-06-06
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Implant Stability
timeFrame: 3-18 weeks
Secondary outcomes:
measure: Marginal bone level change
timeFrame: 2 years
Other outcomes:
Locations:
city: Regensburg
country: Germany
facility: Universitat Regensburg
state: Bayern
city: Dusseldorf
country: Germany
facility: Heinrich Heine Universitat Dusseldorf
state: Nordhein-Westfalen
city: Mainz
country: Germany
facility: Universitatsmedizin Mainz
state: Rheinland-Pfalz
Study officials:
affiliation: Universitatsbedizin Mainz
name: Wilfried Wagner
role: PRINCIPAL_INVESTIGATOR
References: