Implant Placement Depth and Peri-Implant Tissue Outcomes

April 14, 2026 updated by: Juan Carlos Bernabeu Mira, University of Valencia

Influence of Implant Placement Depth (-2 mm vs -4 mm Subcrestal) on Peri-implant Tissue Conditions: a Randomized Clinical Trial Protocol

The primary aim of this randomized clinical trial is to evaluate the influence of subcrestal implant placement depth (-2 mm vs -4 mm) on peri-implant marginal bone level changes, including marginal bone loss and bone remodeling. Secondary outcomes include implant success, peri-implant probing depth (PPD), and bleeding on probing (BoP).

Partially edentulous patients requiring fixed implant-supported prosthetic rehabilitation with two implants in posterior maxillary or mandibular regions will be included. Implants will be placed subcrestally at either -2 mm or -4 mm from the bone crest, following a submerged healing protocol. Allocation to insertion depth will be randomized. Marginal bone level changes will be assessed using standardized periapical radiographs at second-stage surgery, prosthesis placement, and at 1, 3, 6, and 12 months after functional loading. PPD and BoP will be recorded at the same time points.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Juan Carlos Bernabeu Mira, DDS, MSc, PhD
  • Phone Number: +34 697348312
  • Email: juan.c.bernabeu@uv.es

Study Locations

  • Spain
    • Valencia
      • Valencia, Valencia, Spain, 46003
        • University of Valencia
        • Contact:
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients ≥18 years old with partial edentulism.
  • Need for rehabilitation with fixed implant-supported prostheses in posterior regions.
  • Availability of minimum bone height for implants ≥6 mm in length.
  • Minimum bone width without the need for guided bone regeneration.
  • Supracrestal soft tissue thickness ≥2 mm.
  • Non-smokers or smokers of ≤10 cigarettes/day.
  • Plaque index and bleeding on probing <20%.
  • Probing depth ≤3 mm.
  • Signed informed consent.

Exclusion Criteria:

  • Systemic diseases contraindicating implant surgery.
  • Treatment with intravenous bisphosphonates.
  • Head and neck radiotherapy.
  • Uncontrolled diabetes.
  • Pregnancy or breastfeeding.
  • Alcohol or drug use.
  • Psychiatric disorders.
  • Need for bone regeneration procedures.
  • Inability to complete follow-up.
  • Implant failure during the study period.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: -2 mm subcrestal implant placement with 2-mm slim transmucosal abutments
Participants in this group will receive implants placed 2 mm below the level of the alveolar bone crest. Implants will share the same design, surface characteristics, and prosthetic connection, including platform switching. Slim transmucosal abutments with a height of 2-mm will be placed according to the subcrestal depth to ensure an adequate transmucosal profile and a stable relationship between the implant, peri-implant soft tissues, and the prosthetic restoration
Procedure: Subcrestal Implant Placement with Transmucosal Abutment and One Abutment-One Time Protocol
Participants will receive bone-level dental implants placed subcrestally at either -2 mm or -4 mm below the bone crest in healed posterior sites of the maxilla or mandible, according to randomization. Implant placement will follow the manufacturer's drilling protocol, achieving a final insertion torque of at least 35 Ncm. A transmucosal abutment will be connected at the time of surgery, with height selected based on implant placement depth (2-3 mm for -2 mm placement and 4-5 mm for -4 mm placement). The abutment will be tightened to a final torque of at least 30 Ncm following a one abutment-one time protocol.
Experimental: -2 mm subcrestal implant placement with 3-mm slim transmucosal abutments
Participants in this group will receive implants placed 2 mm below the level of the alveolar bone crest. Implants will share the same design, surface characteristics, and prosthetic connection, including platform switching. Slim transmucosal abutments with a height of 3-mm will be placed according to the subcrestal depth to ensure an adequate transmucosal profile and a stable relationship between the implant, peri-implant soft tissues, and the prosthetic restoration.
Procedure: Subcrestal Implant Placement with Transmucosal Abutment and One Abutment-One Time Protocol
Participants will receive bone-level dental implants placed subcrestally at either -2 mm or -4 mm below the bone crest in healed posterior sites of the maxilla or mandible, according to randomization. Implant placement will follow the manufacturer's drilling protocol, achieving a final insertion torque of at least 35 Ncm. A transmucosal abutment will be connected at the time of surgery, with height selected based on implant placement depth (2-3 mm for -2 mm placement and 4-5 mm for -4 mm placement). The abutment will be tightened to a final torque of at least 30 Ncm following a one abutment-one time protocol.
Experimental: -4 mm subcrestal implant placement with 4-mm slim transmucosal abutments
Participants in this group will receive implants placed 4 mm below the level of the alveolar bone crest. Implants will share the same design, surface characteristics, and prosthetic connection, including platform switching. Slim transmucosal abutments with a height of 4-mm will be placed according to the subcrestal depth to ensure an adequate transmucosal profile and a stable relationship between the implant, peri-implant soft tissues, and the prosthetic restoration.
Procedure: Subcrestal Implant Placement with Transmucosal Abutment and One Abutment-One Time Protocol
Participants will receive bone-level dental implants placed subcrestally at either -2 mm or -4 mm below the bone crest in healed posterior sites of the maxilla or mandible, according to randomization. Implant placement will follow the manufacturer's drilling protocol, achieving a final insertion torque of at least 35 Ncm. A transmucosal abutment will be connected at the time of surgery, with height selected based on implant placement depth (2-3 mm for -2 mm placement and 4-5 mm for -4 mm placement). The abutment will be tightened to a final torque of at least 30 Ncm following a one abutment-one time protocol.
Experimental: -4 mm subcrestal implant placement with 5-mm slim transmucosal abutments
Participants in this group will receive implants placed 4 mm below the level of the alveolar bone crest. Implants will share the same design, surface characteristics, and prosthetic connection, including platform switching. Slim transmucosal abutments with a height of 5-mm will be placed according to the subcrestal depth to ensure an adequate transmucosal profile and a stable relationship between the implant, peri-implant soft tissues, and the prosthetic restoration.
Procedure: Subcrestal Implant Placement with Transmucosal Abutment and One Abutment-One Time Protocol
Participants will receive bone-level dental implants placed subcrestally at either -2 mm or -4 mm below the bone crest in healed posterior sites of the maxilla or mandible, according to randomization. Implant placement will follow the manufacturer's drilling protocol, achieving a final insertion torque of at least 35 Ncm. A transmucosal abutment will be connected at the time of surgery, with height selected based on implant placement depth (2-3 mm for -2 mm placement and 4-5 mm for -4 mm placement). The abutment will be tightened to a final torque of at least 30 Ncm following a one abutment-one time protocol.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in peri-implant marginal bone level (mm)
Time Frame: From abutment placement (baseline time [TB]), 1 month post (T1), and at 3 (T3) (prosthetic loading) , 6 (T6), and 12 (T12) months after definitive prosthesis placement.
Parallelized periapical radiographs will be obtained and a calibrated digital tool will be used to determine the vertical distance from the implant-abutment junction to the most coronal bone-to-implant contact on the mesial and distal sides. Unit of measure: Milimeters (mm)
From abutment placement (baseline time [TB]), 1 month post (T1), and at 3 (T3) (prosthetic loading) , 6 (T6), and 12 (T12) months after definitive prosthesis placement.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Peri-implant probing depth (mm)
Time Frame: 1 month post-op (T1), and at months 3 (T3) (prosthetic loading) , 6 (T6), and 12 (T12) after definitive prosthesis placement.
Peri-implant soft tissue condition will be assessed by recording PPD using a periodontal probe at six surfaces per implant (mesiobuccal, midbuccal, distobuccal, and the corresponding lingual/palatal sites) to calculate the mean of every implant. Unit of measure: Milimeters (mm)
1 month post-op (T1), and at months 3 (T3) (prosthetic loading) , 6 (T6), and 12 (T12) after definitive prosthesis placement.
Bleeding on probing (presence/absence)
Time Frame: 1 month post-op (T1), and at months 3 (T3) (prosthetic loading) , 6 (T6), and 12 (T12) after definitive prosthesis placement.
Bleeding on probing will be measured by gently passing a periodontal probe (using ~20-25g of force) to the base of the sulcus/pocket of the prosthesis at six surfaces per implant (mesiobuccal, midbuccal, distobuccal, and the corresponding lingual/palatal sites), then waiting 30 seconds to observe bleeding. It will be recorded as a dichotomous score (yes/no). Unit of measure: Percentage of sites showing bleeding per implant.
1 month post-op (T1), and at months 3 (T3) (prosthetic loading) , 6 (T6), and 12 (T12) after definitive prosthesis placement.
Implant success
Time Frame: From the time of surgery through the end of the 12-month follow-up period after definitive prosthesis placement.
Assessment of the implants will be performed by categorizing them into: success (optimal health), satisfactory survival, compromised survival, or failure.
From the time of surgery through the end of the 12-month follow-up period after definitive prosthesis placement.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Baseline characteristics
Time Frame: At enrollment time.
Baseline variables will be collected for descriptive purposes and will not be combined into a single outcome measure. These include: age (years); sex (male/female); smoking habit (non-smoker or ≤10 cigarettes/day); brushing frequency (0, 1-2, or 3 times/day); edentulism type (interdental or free end); periodontal phenotype (thin or thick); antagonist type (natural teeth, tooth-supported bridge, implant-supported prosthesis, or removable prosthesis); cause of tooth loss (caries, periodontitis, or fracture); implant location (arch and quadrant); and soft tissue thickness (mm).
At enrollment time.

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Valencia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ana Verónica Blanco Besteiro, DDS, MSc and PhD candidate, University of Valencia

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 (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 15, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 20, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 20, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 7, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 17, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UV-INV-ETICA-3792383

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The plan to share individual participant data (IPD) has not yet been determined.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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Conditions

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