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

NCT ID: NCT07288606

Last Updated: 2026-01-06

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-02
• Study Completion Date: 2026-12-30

Brief Summary

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).

Detailed Description

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

Conditions

Dental Implant; Implant Stability

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

Bone Level

Placement of a bone-level dental implant. The implant-abutment interface is at the level of the alveolar bone crest.

Group Type: EXPERIMENTAL

Dental implant placement

Intervention Type: PROCEDURE

Surgical placement of Bone-level and Tissue-level dental implants.

Tissue Level

Placement of a tissue-level dental implant. The implant-abutment interface is located supracrestally, at the level of the soft tissue.

Group Type: ACTIVE_COMPARATOR

Dental implant placement

Intervention Type: PROCEDURE

Surgical placement of Bone-level and Tissue-level dental implants.

Interventions

Dental implant placement

Surgical placement of Bone-level and Tissue-level dental implants.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Barcelona

OTHER

Sponsor Role: lead

Responsible Party

José López Lopez

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

JOSE L LOPEZ, MSC

Role: PRINCIPAL_INVESTIGATOR

University of Barcelona

Locations

Hospital Odontologic

Barcelona, L'Hospitalet de Llobregat, Spain

Countries

Spain

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

2022-033-1

Identifier Type: -

Identifier Source: org_study_id