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

NCT07288606 | Active Not Recruiting DMC

• 1 other identifier: 2022-033-1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

Dental Implant; Implant Stability

Keywords

Bone level; tissue level; osseointegration; biomechanical analysis; implant design; Insertion torque

Outcome Measures

Primary Outcomes (2)

• Torque

  N·cm

  up to 24 weeks

• marginal bone loss

  mm

  6 months

Study Arms (2)

Bone Level

EXPERIMENTAL

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

Procedure: Dental implant placement

Tissue Level

ACTIVE COMPARATOR

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

Interventions

Dental implant placement PROCEDURE

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

Bone Level; Tissue Level

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Barcelona: lead

Study Sites (1)

Hospital Odontologic

Barcelona, L'Hospitalet de Llobregat, 89070, Spain

Location

Study Officials

• JOSE L LOPEZ, MSC

  University of Barcelona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Model Details: placement of dental implants in bone level and tissue level

Study Record Dates

• First Submitted: June 12, 2024
• First Posted: December 17, 2025
• Study Start: December 2, 2022
• Primary Completion: December 1, 2023
• Study Completion (Estimated): December 30, 2026
• Last Updated: January 6, 2026

Record last verified: 2025-02

Locations

ES (1)