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Analysising the Marginal Bone Loss, Torque and Implant Stability Placed in Bone and Tissue Level Dental Implants

U

University of Barcelona

Status

Active, not recruiting

Conditions

Dental Implant
Implant Stability

Treatments

Procedure: Dental implant placement

Study type

Interventional

Funder types

Other

Identifiers

NCT07288606
2022-033-1

Details and patient eligibility

About

It is a prospective clinical study to compare two implants of the same brand of a similar design for implantation [either at the bone tissue level or at the soft tissue level], in order to evaluate the marginal bone loss of each dental implant in mm. 96 patients will be analyzed (an expected N of 48 per group, hoping to reach 100 implants per arm).

Full description

it is a study to evualte the marginal bone loss in bone level and tissue level dental implants

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients of both sexes, over 18 years of age, who need dental implant placement for prosthetic rehabilitation. Whether partially or completely in both the maxilla and the mandible.
  • Patients with residual alveolar ridge with at least 8 mm of bone height and 4 mm of width.
  • Patients must have the ability to understand and decide when voluntarily signing the informed consent before carrying out any intervention related to the study.
  • Patients who, after being informed about the objectives and procedures of the research, agree will sign the informed consent form. And they are ready to carry out the different study visits.

Exclusion criteria

  • Patients with uncontrolled systemic diseases (ASA ≥ III).
  • Patients who do not have 8mm bone height and/or 4mm width
  • Patients who require bone regeneration
  • Patients with severe periodontal disease or acute pericoronitis.
  • Pregnant and breastfeeding women.
  • Patients with Deficient or Inadequate Oral Hygiene.
  • Patients with severe bruxism.
  • Patients taking bisphosphonates or other antiresority medications.
  • Smoker of more than 10 cigarettes/day.
  • Patients with uncontrolled diabetes mellitus.
  • Psychiatric illnesses or unrealistic expectations.
  • Immunodepressed or immunocompromised patient.

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

20 participants in 2 patient groups

Bone Level
Experimental group
Description:
Placement of a bone-level dental implant. The implant-abutment interface is at the level of the alveolar bone crest.
Treatment:
Procedure: Dental implant placement
Tissue Level
Active Comparator group
Description:
Placement of a tissue-level dental implant. The implant-abutment interface is located supracrestally, at the level of the soft tissue.
Treatment:
Procedure: Dental implant placement

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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