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

December 31, 2025 updated by: José López Lopez, University of Barcelona

Marginal Bone Loss in Implants Placed in Bone Level and Tissue Level

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • L'Hospitalet de Llobregat
      • Barcelona, L'Hospitalet de Llobregat, Spain, 89070
        • Hospital Odontologic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bone Level
Placement of a bone-level dental implant. The implant-abutment interface is at the level of the alveolar bone crest.
Procedure: Dental implant placement
Surgical placement of Bone-level and Tissue-level dental implants.
Active Comparator: Tissue Level
Placement of a tissue-level dental implant. The implant-abutment interface is located supracrestally, at the level of the soft tissue.
Procedure: Dental implant placement
Surgical placement of Bone-level and Tissue-level dental implants.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Torque
Time Frame: up to 24 weeks
N·cm
up to 24 weeks
marginal bone loss
Time Frame: 6 months
mm
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Barcelona

Investigators

  • Principal Investigator: JOSE L LOPEZ, MSC, University of Barcelona

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 2, 2022

Primary Completion (Actual)

December 1, 2023

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

June 12, 2024

First Submitted That Met QC Criteria

December 3, 2025

First Posted (Estimated)

December 17, 2025

Study Record Updates

Last Update Posted (Actual)

January 6, 2026

Last Update Submitted That Met QC Criteria

December 31, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2022-033-1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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