Clinical trial NCT04237545: A Clinical Study of the T3 Short Dental Implant System
Official title: A Prospective, Randomized, Clinical Study of the Safety, Efficacy and Clinical Benefits of the T3® Short Dental Implant System Placed in the Posterior Regions
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Edentulous Jaw
Lead sponsor: ZimVie
Sponsor class: INDUSTRY
First posted: 2020-01-23
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The patient will be randomized to receive either the T3 short (test device) or the T3 standard length, ≥10mm, (control device) implant.
Primary purpose: TREATMENT

Brief summary: This clinical study will evaluate the safety and performance of the T3 short dental implant when placed in the posterior maxilla and mandible.

Detailed description: This is a prospective, randomized-controlled, multicenter study in which patients in need of dental implants in the posterior maxilla and mandible will be treated with either the T3 short implant (test device) or the T3 standard length implant (control device). Qualified patients will have one or more edentulous areas in the posterior region to be restored using a single crown. All implants will be placed using a single-stage surgical protocol. A provisional or definitive (final) prosthesis will be placed (cemented or screw-retained) within 8 weeks of implant placement. All prosthetic work must be completed no later than 6 months following implant placement surgery.

Each site will be selected to place implants (both test and control) in either the DCD or the non-DCD configuration (a total of 30 implants per site). Among all study sites, a total of 120 implants (60 test, 60 control) will be enrolled in this study (any geographic region). The patient will be randomized to receive either the T3 short (test device) or the T3 standard length, ≥10mm, (control device) implant. Only patients meeting the inclusion / exclusion criteria and providing informed consent form will be enrolled into study. The duration of the study will be approximately 4 years from initiation to completion of data analysis and reporting.

Eligibility criteria: Inclusion Criteria:

1. Patients of either sex and at least 18 years of age
2. Patients for whom a decision has already been made to use a dental implant for the restoration of existing partial edentulism in the posterior mandible or maxilla.
3. Prior extracted sites (at least 4 months after extraction) preferred; immediate extractions allowed
4. Splinting to a natural tooth is allowed for the short length (test) implants
5. Intact buccal table as verified by CBCT or during surgery. If absent, patient should be excluded from enrollment in the study.
6. Presence of opposing dentition (antagonist) that will allow for functional occlusion.
7. The site intended for implant placement should have a minimum amount of keratinized gingiva of 2mm and a sufficient vertical bone height (8 - 10 mm in the maxilla; 10mm in the mandible); a short implant (as determined by randomization) will be placed without the need for augmentation except for minor dehiscence, which can be augmented with autogenous bone chips to improve soft tissue attachment. If site was randomized to long length implant (control) (with a minimum of 8mm vertical bone height in the maxilla or less than 10 mm in the mandible) it will have simultaneous augmentation procedure (sinus elevation in the maxilla; vertical ridge augmentation in the mandible).
8. The site intended for implant placement should have approximately 1.5mm buccal-lingual distance on each side in order to allow for wide platform implant (5 and 6mm diameter).
9. Patients must be physically able to tolerate conventional surgical and restorative procedures.
10. Patients who provide a signed informed consent
11. Patients who agree to be evaluated for each study visit.

Exclusion Criteria:

1. Patients with known systemic diseases such as uncontrolled diabetes, endocrine disease, heart disease, immuno-compromised, or mental disorders.
2. Patients with current use of non-steroidal anti-inflammatory drugs, bisphosphonates or corticosteroid treatments.
3. Patients with active infection or severe inflammation in the areas intended for treatment.
4. Patients with a \> 10 cigarette per day smoking habit.
5. Patients with a history of therapeutic radiation to the head or jaw.
6. Patients receiving other dental treatment(s) during the study that could have a negative impact on the healing phase of the study treatment sites.
7. Patients who are known to be pregnant at the screening visit or planning to become pregnant within 6 months of study enrollment.
8. Patients with evidence of severe parafunctional habits such as bruxing or clenching.
9. Patients who have previously failed dental implants at the site intended for study implant placement
10. Patients with HIV or Hepatitis infection
11. Patients with a history of generalized severe chronic periodontal disease

Primary outcomes:
measure: Crestal Bone regression
timeFrame: 4 years
Secondary outcomes:
measure: Implant integration and survival
timeFrame: 4 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dr. Xiaozhe Han
state: Massachusetts
city: Dearborn Heights
country: United States
facility: Dr. Suheil Boutros
state: Michigan
city: Padova
country: Italy
facility: Dr. Stefano Sivolella
city: Tarragona
country: Spain
facility: Dr. Jordi Gargallo
state: Catalonia
Study officials:
affiliation: ZimVie
name: Hai Bo Wen, PhD
role: STUDY_DIRECTOR
References: