Alveolar Bone Loss Clinical Trial
Official title:
Stability of the Marginal Bone Around Subcrestal Implants Inserted at Different Depths. A Multicenter Clinical Study
Verified date | August 2022 |
Source | International Piezosurgery Academy |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The extent of marginal bone remodeling around the neck of dental implants has been used for many years as a criterion for defining their long-term success. Apico-coronal position represents a crucial factor in this field. This study aims to establish the optimal insertion depth of a subcrestal implant, with the aim of minimizing the bone resorption.
Status | Completed |
Enrollment | 22 |
Est. completion date | July 15, 2022 |
Est. primary completion date | December 15, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years and older |
Eligibility | Inclusion Criteria: - indications for the insertion of two implants in a free edentulous ridge in the posterior area of both arches (premolar / molar area), based on a careful diagnosis and treatment plan; - presence of a residual bone crest with a minimum surgical height of 9 mm, and a thickness of at least 6 mm at the level of the planned implant sites; - the bone crest must be healed (at least 6 months after tooth loss / extraction of the corresponding dental element); - native bone; - plaque index below 25% and bleeding index below 20%; - facial-lingual width of the adherent gingiva = 4 mm; - age of the patient> 18 years; - patients must be able to review and understand the study protocol; - informed consent. Exclusion Criteria: - acute myocardial infarction within the last 6 months; - uncompensated coagulation disorders; - uncontrolled diabetes (HbA1c> 7.5%); - head / neck radiotherapy in the last 24 months; - immunocompromised patients (HIV infection or chemotherapy within the last 5 years); - present or past treatment with antiresorptive drugs; - psychological or psychiatric problems; - alcohol or drug abuse; - presence of uncontrolled periodontal disease - acute and chronic endodontic infections next to implant site. |
Country | Name | City | State |
---|---|---|---|
Italy | Dr. Claudio Stacchi Office | Gorizia | Friuli Venezia Giulia |
Lead Sponsor | Collaborator |
---|---|
International Piezosurgery Academy | University of Trieste |
Italy,
Galindo-Moreno P, León-Cano A, Monje A, Ortega-Oller I, O'Valle F, Catena A. Abutment height influences the effect of platform switching on peri-implant marginal bone loss. Clin Oral Implants Res. 2016 Feb;27(2):167-73. doi: 10.1111/clr.12554. Epub 2015 Feb 11. — View Citation
Spinato S, Stacchi C, Lombardi T, Bernardello F, Messina M, Zaffe D. Biological width establishment around dental implants is influenced by abutment height irrespective of vertical mucosal thickness: A cluster randomized controlled trial. Clin Oral Implants Res. 2019 Jul;30(7):649-659. doi: 10.1111/clr.13450. Epub 2019 May 12. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | marginal bone loss | radiographic assessment | at implant insertion | |
Primary | marginal bone loss | radiographic assessment | 5 month after implant insertion | |
Primary | marginal bone loss | radiographic assessment | 6 months after prosthetic loading | |
Primary | marginal bone loss | radiographic assessment | 12 months after prosthetic loading | |
Primary | marginal bone loss | radiographic assessment | 3 years after prosthetic loading | |
Primary | marginal bone loss | radiographic assessment | 5 years after prosthetic loading |
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