Implant Geometry, Osseointegration, Soft Tissue Volume, Marginal Bone Levels, Soft Tissue Recession, Volumetric Analysis Clinical Trial
Official title:
The Influence of a New Implant Neck Configuration on Hard and Soft Tissue Healing. A Randomized Controlled Clinical Trial
Title: Randomized Controlled Clinical Trial comparing two dental implants with different neck
configurations.
Objective: To evaluate the changes in peri-implant soft tissues and marginal bone level when
using a one-piece implant with a widening transgingival machined collar and a one-piece
implant with a tapering transgingival machined collar.
Design: The study will be a prospective parallel randomized clinical trial with a 12 month
follow up conducted in 5 private dental practices. A total of 50 patients meeting the
inclusion criteria will be randomized in one of the two groups to receive 1 single implant
placed in healed ridges. Radiographic and clinical measurements will be taken post-insertion,
baseline (post-loading) 6 and 12 months after loading.
Study Hypothesis: The hypothesis of this study is that there will be no differences in the
preservation of the peri-implant marginal bone level and peri-implant soft tissues between
the two implant neck designs.
| Status | Recruiting |
| Enrollment | 52 |
| Est. completion date | March 17, 2021 |
| Est. primary completion date | November 17, 2020 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Male or female =18 years old - Each patient will have one missing tooth in the posterior mandible (positions 4-6). There must be a natural tooth mesially and distally to the implant site. Free end situation are not allowed. - Adequate bone quality and quantity at the implant site to permit the insertion of a SWEDEN AND MARTINA® Prama Implant in the diameter of 4.25 mm and in the length of 8.5 mm, 10 mm or a Straumann Tissue Level in the diameter of 4.1 mm and in the length of 8 mm or 10mm. - Opposing dentition must be natural teeth or teeth/implant supported fixed restoration(s). - Patient has been informed of the follow-up visits and is willing to return to the clinical center for these follow-up visit. Exclusion Criteria: - These exclusion criteria might be systemic or local. In addition to the general contra-indication for dental implants the following exclusion criteria will be observed: Systemic exclusion criteria: - Medical conditions requiring prolonged use of steroids and/or with medications that can interfere with bone metabolism - History of leukocyte dysfunction and deficiencies - History of neoplasic disease requiring the use of radiation or chemotherapy - Patients with history of renal failure - Patients with metabolic bone disorders such as osteoporosis - History of uncontrolled endocrine disorders - Physical handicaps that would interfere with the ability to perform adequate oral hygiene - Use of any investigational drug or device within the 30 day period immediately prior to implant surgery on study day 0 - Alcoholism or drug abuse - History of immunodeficiency syndromes - Patients who smoke >20 cigarettes per day or cigar equivalents. - Conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance, unreliability Local exclusion criteria: - Any bone augmentation on the implant site which was performed in the previous 3 months - Local inflammation, including untreated periodontitis - Mucosal diseases such as erosive lichen planus - History of local irradiation therapy - Presence of osseous lesions - Unhealed extraction sites (less than 6 weeks post extraction of teeth in intended sites) - Severe bruxing or clenching habits - Persistent intraoral infection Exclusion criteria at surgery: - Lack of primary stability of implant. - Presence of vertical dehiscence - Unable to place the implant according to the prosthetic requirements. In any of these instances the patient will not be included in the study and a new patient will be recruited and randomized. |
| Country | Name | City | State |
|---|---|---|---|
| Spain | PerioCentrum Madrid | Madrid |
| Lead Sponsor | Collaborator |
|---|---|
| PerioCentrum Research |
Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | soft tissue volumetric changes | soft tissue volumetric changes between baseline and one year | 1 year | |
| Secondary | marginal bone levels | marginal bone levels between baseline and at one year | 1 year | |
| Secondary | implant survival rate | no mobility at crown placement and at one year | 1 year | |
| Secondary | probing pocket depth | probing pocket depth at crown placement and at one year | 1 year | |
| Secondary | recession | recession at crown placement and at one year | 1 year | |
| Secondary | keratinized mucosa | keratinized mucosa at crown placement and at one year | 1 year |