Dental Implant PlacementNCT07535528
Implant Placement Depth and Peri-Implant Tissue Outcomes
A study testing Subcrestal Implant Placement with Transmucosal Abutment and One Abutment-One Time Protocol in people with Dental Implant Placement and Soft Tissue Management in Subcrestal Dental Implants, run by University of Valencia at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Implant Placement, Soft Tissue Management in Subcrestal Dental Implants, Marginal Bone Loss
- What is being tested?
- Subcrestal Implant Placement with Transmucosal Abutment and One Abutment-One Time Protocol
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- 15 May 2026to 20 Jul 2027
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- Plaque index and bleeding on probing <20%.
- Probing depth ≤3 mm.
- Signed informed consent.
Who cannot join
- Systemic diseases contraindicating implant surgery.
- Treatment with intravenous bisphosphonates.
- Head and neck radiotherapy.
- Uncontrolled diabetes.
- Pregnancy or breastfeeding.
- Alcohol or drug use.
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- Psychiatric disorders.
- Need for bone regeneration procedures.
- Inability to complete follow-up.
- Implant failure during the study period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Dental Implant Placement, Soft Tissue Management in Subcrestal Dental Implants, Marginal Bone Loss
- Being tested
- Subcrestal Implant Placement with Transmucosal Abutment and One Abutment-One Time Protocol
- Keywords
- Dental implant, Subcrestal placement, Marginal bone loss, Insertion depth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subcrestal Implant Placement with Transmucosal Abutment and One Abutment-One Time ProtocolProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| -2 mm subcrestal implant placement with 2-mm slim transmucosal abutments | Experimental | 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 Receives: Procedure: Subcrestal Implant Placement with Transmucosal Abutment and One Abutment-One Time Protocol |
| -2 mm subcrestal implant placement with 3-mm slim transmucosal abutments | Experimental | 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. Receives: Procedure: Subcrestal Implant Placement with Transmucosal Abutment and One Abutment-One Time Protocol |
| -4 mm subcrestal implant placement with 4-mm slim transmucosal abutments | Experimental | 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. Receives: Procedure: Subcrestal Implant Placement with Transmucosal Abutment and One Abutment-One Time Protocol |
| -4 mm subcrestal implant placement with 5-mm slim transmucosal abutments | Experimental | 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. Receives: Procedure: Subcrestal Implant Placement with Transmucosal Abutment and One Abutment-One Time Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in peri-implant marginal bone level (mm)
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)
Measured: 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 outcomes (3)
Peri-implant probing depth (mm)
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)
Measured: 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)
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.
Measured: 1 month post-op (T1), and at months 3 (T3) (prosthetic loading) , 6 (T6), and 12 (T12) after definitive prosthesis placement.
Implant success
Assessment of the implants will be performed by categorizing them into: success (optimal health), satisfactory survival, compromised survival, or failure.
Measured: From the time of surgery through the end of the 12-month follow-up period after definitive prosthesis placement.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start15 May 2026
- Primary completion20 Nov 2026 (estimated)
- Study completion20 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Implant PlacementStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan Carlos Bernabeu Mira, University of Valencia
- Investigators
- Ana Verónica Blanco Besteiro, DDS, MSc and PhD candidate, Principal investigator, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07535528
- Sponsor's protocol ID
- UV-INV-ETICA-3792383
- Status last verified
- Jul 2026
- First submitted
- 7 Apr 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The plan to share individual participant data (IPD) has not yet been determined.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Implant Placement Depth (-2 mm vs -4 mm Subcrestal) on Peri-implant Tissue Conditions: a Randomized Clinical Trial Protocol
- ClinicalTrials.gov ID
- NCT07535528
- Acronym / sponsor ID
- UV-INV-ETICA-3792383
- Conditions
- Dental Implant Placement, Soft Tissue Management in Subcrestal Dental Implants, Marginal Bone Loss
- Keywords
- Dental implant, Subcrestal placement, Marginal bone loss, Insertion depth
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 15 May 2026 (actual)
- Primary completion
- 20 Nov 2026 (estimated)
- Study completion
- 20 Jul 2027 (estimated)
- First posted
- 17 Apr 2026 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| -2 mm subcrestal implant placement with 2-mm slim transmucosal abutments | Experimental | Procedure: Subcrestal Implant Placement with Transmucosal Abutment and One Abutment-One Time ProtocolParticipants 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 |
| -2 mm subcrestal implant placement with 3-mm slim transmucosal abutments | Experimental | Procedure: Subcrestal Implant Placement with Transmucosal Abutment and One Abutment-One Time ProtocolParticipants 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. |
| -4 mm subcrestal implant placement with 4-mm slim transmucosal abutments | Experimental | Procedure: Subcrestal Implant Placement with Transmucosal Abutment and One Abutment-One Time ProtocolParticipants 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. |
| -4 mm subcrestal implant placement with 5-mm slim transmucosal abutments | Experimental | Procedure: Subcrestal Implant Placement with Transmucosal Abutment and One Abutment-One Time ProtocolParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (10 listed)
- Systemic diseases contraindicating implant surgery.
- Treatment with intravenous bisphosphonates.
- Head and neck radiotherapy.
- Uncontrolled diabetes.
- Pregnancy or breastfeeding.
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 |
|---|---|---|
| Subcrestal Implant Placement with Transmucosal Abutment and One Abutment-One Time ProtocolParticipants 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. | Procedure or surgery | -2 mm subcrestal implant placement with 2-mm slim transmucosal abutments, -2 mm subcrestal implant placement with 3-mm slim transmucosal abutments, -4 mm subcrestal implant placement with 4-mm slim transmucosal abutments, -4 mm subcrestal implant placement with 5-mm slim transmucosal abutments |
Primary outcome
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)
3 secondary outcomes
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.
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.
Implant success
Time frame: From the time of surgery through the end of the 12-month follow-up period after definitive prosthesis placement.
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 13 Jul 2026.
- Individual participant dataSharing planned: Undecided. The plan to share individual participant data (IPD) has not yet been determined.
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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.
Ana Verónica Blanco Besteiro, DDS, MSc and PhD candidate principal investigator
University of Valencia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Subcrestal Implant Placement with Transmucosal Abutment and One Abutment-One Time Protocol in people with Dental Implant Placement and Soft Tissue Management in Subcrestal Dental Implants, run by University of Valencia 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 9 inclusion and 10 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 13 Jul 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?
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.). 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 13 Jul 2026.