Long-term Study in Early Loaded Hydrophilic Surface Implants

Completed

• Conditions: Dental Implant
• Interventions: Device: Dental implant (ELEMENT RC INICELL, Thommen Medical)

• Registration Number: NCT06138392
• Lead Sponsor: University of Bern

Brief Summary

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

Not available

Study Timeline

• Study Start: 2020-09-01
• Primary Completion: 2021-09-01
• Study Completion: 2021-12-01
• Study First Submitted: 2023-10-10
• Status Verified: 2023-11
• Study First Submitted QC: 2023-11-13
• Last Update Submitted: 2023-11-13
• Study First Posted: 2023-11-18
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Experimental group	Dental implant (ELEMENT RC INICELL, Thommen Medical)	-

Primary Outcome Measures

Name	Time	Method
Clinical performance - implant success	10 years	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.
Clinical performance - complications	10 years	A visual exploration of each implant and reconstruction was performed to detect any biological and technical complications.
Clinical performance	10 years	Patient satisfaction with the implant treatment was evaluated using a 10 cm visual analogue scale (VAS). From 0 (The worst) to 10 (The best).
Clinical performance - survival	10 years	Survival was classified as the continued presence of both the implant and reconstruction in the mouth with no need of replacement and/or repair
Clinical performance - peri-implant health	10 years	During the clinical follow-up appointments, peri-implant health was evaluated by using a periodontal probe.; Keratinized mucosa (mm) All parameters were evaluated mesially, distally, buccally, and orally in each implant; following the EFP guidelines (European Federation of Periodontology 2018).
Clinical performance - prosthetic success	10 years	Prosthetic success was defined as the absence of technical complications without needing any reconstruction repair.
Clinical performance - PIBL, implant-crown fit	10 years	To assess implant-crown fit (misfit yes/no), a standardized digital periapical radiograph was taken at the scheduled follow-up visits.; An independent examiner performed a radiological linear evaluation (mm) using image analysis software (ImageJ)

Trial Locations

Locations (1)

University of Bern; 🇨🇭 Bern, Switzerland