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Completed

NCT Number: NCT06138392

Long-term Study in Early Loaded Hydrophilic Surface Implants

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.

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Key information

Conditions

Dental Implant

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Bern

Bern, 3010, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dental implant (ELEMENT RC INICELL, Thommen Medical)

Device

Dental implant

Primary outcomes

  1. Clinical performance - survival

    Time frame: 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

  2. Clinical performance - implant success

    Time frame: 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.

  3. Clinical performance - prosthetic success

    Time frame: 10 years

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

  4. Clinical performance - complications

    Time frame: 10 years

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

  5. Clinical performance - peri-implant health

    Time frame: 10 years

    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).

  6. Clinical performance - peri-implant health

    Time frame: 10 years

    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).

  7. Clinical performance - peri-implant health

    Time frame: 10 years

    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).

  8. Clinical performance - peri-implant health

    Time frame: 10 years

    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).

  9. Clinical performance - peri-implant health

    Time frame: 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).

  10. Clinical performance - PIBL, implant-crown fit

    Time frame: 10 years

    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)

  11. Clinical performance - PIBL, implant-crown fit

    Time frame: 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)

  12. Clinical performance

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

University of Bern

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 18, 2023
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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