Long-term Study in Early Loaded Hydrophilic Surface Implants

NCT ID: NCT06138392

Last Updated: 2023-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

12 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-01

Study Completion Date

2021-12-01

Brief Summary

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Objective: To assess the clinical outcomes and patient satisfaction of early loaded implants with a hydrophilic, moderately rough surface for partially edentulous patients after a follow-up of 8.5 to 9.5 years.

Materials and methods: A prospective observational single-centre study involving 15 patients with single, delayed placement and early loaded implants in the posterior area was performed. Clinical and radiographical parameters, including biological and technical complications and patient satisfaction, were assessed.

Detailed Description

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Conditions

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Dental Implant

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Experimental group

Dental implant (ELEMENT RC INICELL, Thommen Medical)

Intervention Type DEVICE

Dental implant

Interventions

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Dental implant (ELEMENT RC INICELL, Thommen Medical)

Dental implant

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Individuals between the ages of 18 and 75 years (inclusive)
* Partially edentulous patients with missing teeth in the posterior mandible (positions 34-37 and 44-47) and a healed site at least four weeks after tooth extraction
* Patients requiring a single dental implant
* Patients with physical status 1 or 2 according to the American Society of Anesthesiologists Classification System
* Inadequate native bone quality and quantity to place implants with a diameter of ≥4.0 mm
* Removable prosthesis or complete dentures in the antagonizing dentition
* Written informed consent

Exclusion Criteria

* Patients with compromised general health contraindicating surgical intervention
* Presence of conditions requiring chronic routine prophylactic or prolonged use of antibiotics
* Heavy smokers (exceeding ten cigarettes/day or equivalent) and chewing tobacco users
* Pregnancy or childbearing potential with a positive urine pregnancy test
* Insufficient oral hygiene, untreated periodontitis (any residual pockets \>4 mm), or persistent intra-oral infection
* Mucosal diseases such as erosive lichen planus
* Patients with severe bruxism or clenching habits
* Unwillingness to participate in the study
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Bern

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Martin Schimmel, Prof

Role: STUDY_CHAIR

University of Bern

Locations

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University of Bern

Bern, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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Performance of early loading

Identifier Type: -

Identifier Source: org_study_id

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