Status:
UNKNOWN
The Effect of Concave Healing Abutment on Soft Tissue Healing
Lead Sponsor:
MIS Implant Technologies, Ltd
Collaborating Sponsors:
Charite University, Berlin, Germany
Sachsen Praxen Zahnarztpraxis
Conditions:
Dental Implant Therapy
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The aim of this study is to document the relevance of the concave abutment to form more gingiva when compared to the straight abutment.
Detailed Description
Standard clinical and radiographic examination will assess the need for implant therapy, the number of implants and the rehabilitation type. The pre-operative skeletal data will be observed with a 3D ...
Eligibility Criteria
Inclusion
- a) patients older than 18 years in need of implant therapy in the posterior area of the mandible and maxilla, b) good general/systemic health (ASA type I, II), c) patients who committed to attend all visits of the study, d) placement of a Ø 4.2 mm implant without requiring bone augmentation, e) adequate oral hygiene with FMPS (full mouth plaque score) \< 15% before surgery, f) absence of uncontrolled periodontal disease, g) agreeing to sign an informed consent.
Exclusion
- a) patients with a contributing medical history in which any surgery, disease, condition, or medication susceptible to compromise the healing of soft and hard tissues (e.g. non-controlled diabetes), b) liver function disorder, c) immune system disease, d) immunosuppressant drugs, e) toxic habits other than smoking that might compromise or affect healing, f) patients who have undergone chemotherapy or radiation treatment during the previous 5 years comprising the head and neck area, g) corticosteroids therapy or any other medication that could influence postoperative healing and/or osseointegration, h) bisphosphonate or Denosumab therapy (Prolia®), i) sites that underwent or require a horizontal or vertical bone regeneration procedure, j) inability or unwillingness to attend follow-up visits, k) patients unwilling to sign an informed consent form.
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05975814
Start Date
April 1 2021
End Date
January 1 2025
Last Update
August 4 2023
Active Locations (1)
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1
Mis Implants Technologies Ltd.
Misgav Regional Council, Israel, 2015600