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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Mis Implants Technologies Ltd.

Misgav Regional Council, Israel, 2015600