Status:
UNKNOWN
The Influence of a New Implant Neck Configuration on Hard and Soft Tissue Healing
Lead Sponsor:
PerioCentrum Research
Conditions:
Implant Geometry, Osseointegration, Soft Tissue Volume, Marginal Bone Levels, Soft Tissue Recession, Volumetric Analysis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 w...
Detailed Description
The study will be a prospective parallel randomized clinical trial (RCT) of approximately 20 months of duration, in which each patient will receive 1 implants placed in the posterior mandible. If the ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 17 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 17 2021
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT04308083
Start Date
June 17 2019
End Date
March 17 2021
Last Update
March 13 2020
Active Locations (1)
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1
PerioCentrum Madrid
Madrid, Spain, 28020