Dental ImplantNCT07288606
Analysising the Marginal Bone Loss, Torque and Implant Stability Placed in Bone and Tissue Level Dental Implants
A study testing Dental implant placement in people with Dental Implant and Implant Stability, run by University of Barcelona at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dental Implant, Implant Stability
- What is being tested?
- Dental implant placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 2 Dec 2022to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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
- Being tested
- Dental implant placement
- Keywords
- Bone level, tissue level, osseointegration, biomechanical analysis, implant design, Insertion torque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental implant placementProcedure or surgery
Surgical placement of Bone-level and Tissue-level dental implants.
| Study group | Role | What they receive |
|---|---|---|
| Bone Level | Experimental | Placement of a bone-level dental implant. The implant-abutment interface is at the level of the alveolar bone crest. Receives: 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. Receives: Procedure: Dental implant placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Torque
N·cm
Measured: up to 24 weeks
marginal bone loss
mm
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start2 Dec 2022
- Primary completion1 Dec 2023
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ImplantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- placement of dental implants in bone level and tissue level
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, José López Lopez, University of Barcelona
- Investigators
- JOSE L LOPEZ, MSC, Principal investigator, University of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07288606
- Sponsor's protocol ID
- 2022-033-1
- Status last verified
- Feb 2025
- First submitted
- 12 Jun 2024
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Marginal Bone Loss in Implants Placed in Bone Level and Tissue Level
- ClinicalTrials.gov ID
- NCT07288606
- Acronym / sponsor ID
- 2022-033-1
- Conditions
- Dental Implant, Implant Stability
- Keywords
- Bone level, tissue level, osseointegration, biomechanical analysis, implant design, Insertion torque
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of BarcelonaUniversity, hospital or other
- Study start
- 2 Dec 2022 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 17 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- placement of dental implants in bone level and tissue level
| Arm | Type | Receives |
|---|---|---|
| Bone Level | Experimental | Procedure: Dental implant placementPlacement of a bone-level dental implant. The implant-abutment interface is at the level of the alveolar bone crest. |
| Tissue Level | Active comparator | Procedure: Dental implant placementPlacement of a tissue-level dental implant. The implant-abutment interface is located supracrestally, at the level of the soft tissue. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dental implant placementSurgical placement of Bone-level and Tissue-level dental implants. | Procedure or surgery | Bone Level, Tissue Level |
Primary outcome
Torque
Time frame: up to 24 weeks
N·cm
marginal bone loss
Time frame: 6 months
mm
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
JOSE L LOPEZ, MSC principal investigator
University of Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dental implant placement in people with Dental Implant and Implant Stability, run by University of Barcelona at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Torque (time frame: up to 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.