Clinical trial NCT06138392: Long-term Study in Early Loaded Hydrophilic Surface Implants
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dental Implant
Keywords: Dental implant
Implant crowns
Hydrophilic implant surface
Early loading
Late implant placement
Lead sponsor: University of Bern
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated in an University Clinic

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.


Eligibility criteria: 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

Primary outcomes:
measure: Clinical performance - survival
timeFrame: 10 years
measure: Clinical performance - implant success
timeFrame: 10 years
measure: Clinical performance - prosthetic success
timeFrame: 10 years
measure: Clinical performance - complications
timeFrame: 10 years
measure: Clinical performance - peri-implant health
timeFrame: 10 years
measure: Clinical performance - peri-implant health
timeFrame: 10 years
measure: Clinical performance - peri-implant health
timeFrame: 10 years
measure: Clinical performance - peri-implant health
timeFrame: 10 years
measure: Clinical performance - peri-implant health
timeFrame: 10 years
measure: Clinical performance - PIBL, implant-crown fit
timeFrame: 10 years
measure: Clinical performance - PIBL, implant-crown fit
timeFrame: 10 years
measure: Clinical performance
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: University of Bern
Study officials:
affiliation: University of Bern
name: Martin Schimmel, Prof
role: STUDY_CHAIR
References: