Long-term Study in Early Loaded Hydrophilic Surface Implants

Dental Implant Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06138392
• Other study ID #: Performance of early loading
• Status: Completed
• Start date: September 1, 2020
• Est. completion date: December 1, 2021

Study information

• Verified date: November 2023
• Source: University of Bern
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 1, 2021
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Implant

Intervention

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

Locations

Country	Name	City	State
Switzerland	University of Bern	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University of Bern

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Clinical performance - prosthetic success	Prosthetic success was defined as the absence of technical complications without needing any reconstruction repair.	10 years
Primary	Clinical performance - complications	A visual exploration of each implant and reconstruction was performed to detect any biological and technical complications.	10 years
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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