Long-term Study in Early Loaded Hydrophilic Surface Implants

Clinical and Radiographic Performance of Early Loaded Dental Implants With a Conditioned Hydrophilic Surface: A Prospective Cohort Study With an 8.5- to 9.5-year Follow-up

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 Overview

• Status: Completed
• Conditions: Dental Implant
• Intervention / Treatment: Device: Dental implant (ELEMENT RC INICELL, Thommen Medical)

• Study Type: Observational
• Enrollment (Actual): 12

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • University of Bern

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients treated in an University Clinic

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Experimental group	Device: Dental implant (ELEMENT RC INICELL, Thommen Medical); Dental implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	10 years
Clinical performance - prosthetic success	Prosthetic success was defined as the absence of technical complications without needing any reconstruction repair.	10 years
Clinical performance - complications	A visual exploration of each implant and reconstruction was performed to detect any biological and technical complications.	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).	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).	10 years
Clinical performance - peri-implant health	During the clinical follow-up appointments, peri-implant health was evaluated by using a periodontal probe. Bleeding on probing (yes/no) All parameters were evaluated mesially, distally, buccally, and orally in each implant; following the EFP guidelines (European Federation of Periodontology 2018).	10 years
Clinical performance - peri-implant health	During the clinical follow-up appointments, peri-implant health was evaluated by using a periodontal probe. Pus (yes/no) All parameters were evaluated mesially, distally, buccally, and orally in each implant; following the EFP guidelines (European Federation of Periodontology 2018).	10 years
Clinical performance - peri-implant health	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).	10 years
Clinical performance - PIBL, implant-crown fit	To assess Peri-implant Bone Level (mm), 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)	10 years
Clinical performance - PIBL, implant-crown fit	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)	10 years
Clinical performance	Patient satisfaction with the implant treatment was evaluated using a 10 cm visual analogue scale (VAS). From 0 (The worst) to 10 (The best).	10 years

Collaborators and Investigators

• Sponsor: University of Bern
• Investigators: Study Chair: Martin Schimmel, Prof, University of Bern

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Actual): September 1, 2021
• Study Completion (Actual): December 1, 2021

Study Registration Dates

• First Submitted: October 10, 2023
• First Submitted That Met QC Criteria: November 13, 2023
• First Posted (Estimated): November 20, 2023

Study Record Updates

• Last Update Posted (Estimated): November 20, 2023
• Last Update Submitted That Met QC Criteria: November 13, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Dental implant; Early loading; Implant crowns; Hydrophilic implant surface; Late implant placement
• Other Study ID Numbers: Performance of early loading

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No