Long-term Study in Early Loaded Hydrophilic Surface Implants

University of Bern12 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Dental Implant

Interventions

Dental implant (ELEMENT RC INICELL, Thommen Medical)DEVICE

Dental implant

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Bern

Bern, Switzerland

Outcomes

Primary Outcomes

Clinical performance - survival

Survival was classified as the continued presence of both the implant and reconstruction in the mouth with no need of replacement and/or repair

Time frame: 10 years

Clinical performance - implant success

Implant success was classified as the absence of persisting subjective discomfort (patient compliance), lack of recurrent peri-implant infection with suppuration (European Federation of Periodontology 2018), absence of implant mobility on manual palpation, absence of any continuous peri-implant radiolucency at the radiological assessment.

Time frame: 10 years

Clinical performance - prosthetic success

Prosthetic success was defined as the absence of technical complications without needing any reconstruction repair.

Time frame: 10 years

Clinical performance - complications

A visual exploration of each implant and reconstruction was performed to detect any biological and technical complications.

Time frame: 10 years

Clinical performance - peri-implant health

During the clinical follow-up appointments, peri-implant health was evaluated by using a periodontal probe. Periodontal pockets (1-20) All parameters were evaluated mesially, distally, buccally, and orally in each implant; following the EFP guidelines (European Federation of Periodontology 2018).

Time frame: 10 years

Clinical performance - peri-implant health

During the clinical follow-up appointments, peri-implant health was evaluated by using a periodontal probe. Plaque index (1-3) All parameters were evaluated mesially, distally, buccally, and orally in each implant; following the EFP guidelines (European Federation of Periodontology 2018).

Time frame: 10 years

Data from ClinicalTrials.gov

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