Dental Implant-Abutment DesignsNCT07509281
Peri-implant Tissues Changes for Different Abutment Shapes and Heights
A study testing Bone-Level Implant Placement with Transmucosal Abutment and One Abutment-One Time Protocol in people with Dental Implant-Abutment Designs and Marginal Bone Loss in Different Abutment Designs, run by University of Valencia at 1 site in Spain.
Trial summary
The goal of this randomized clinical trial is to investigate the influence of supracrestal soft tissue on abutments of different heights (2-mm vs. 3-mm) and shapes (cylindrical abutment vs. 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-Abutment Designs, Marginal Bone Loss in Different Abutment Designs, Soft Tissue Management in Subcrestal Dental Implants
- What is being tested?
- Bone-Level 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
- 180 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2026to 30 Sep 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
- Adults aged 18 years or older.
- Posterior edentulism (premolars/molars).
- Good general and oral health, with controlled plaque and bleeding indices.
- Sufficient bone height and width for implant placement without the need for bone regeneration procedures. Patients who require indirect sinus lift procedure simultaneously with implant placement may be included in the study.
- Presence of at least 2 mm of keratinized mucosa around the dental implant.
- Stable occlusion and healthy periodontium.
- Insertion torque ≥ 35 Ncm at the time of implant placement.
- Willingness to comply with study protocol and attend scheduled follow-up visits.
Who cannot join
- Presence of medical conditions that contraindicate implant surgery, such as heavy smoking (>10 cigarettes per day), severe bruxism, pregnancy or breastfeeding, bisphosphonate therapy, and patients undergoing chemotherapy or radiotherapy in the head and/or neck area.
- Active periodontal disease or peri-implant infection.
- Uncooperative patients or patients unable to complete follow- up.
- Implant failures.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Universitat de València
Valencia, Valencia, 46010
Juan C Bernabeu Mira, DDS, MSc, PhD, +34 697348312, juan.c.bernabeu@uv.es
David Peñarrocha Oltra, DDS, MSc, PhD, david.penarrocha@uv.es
About this study
Official title: Influence of Supracrestal Soft Tissue on Peri-implant Bone Changes for Different Abutment Shapes and Heights: A Four-Arm Randomized Clinical Trial
The goal of this randomized clinical trial is to investigate the influence of supracrestal soft tissue on abutments of different heights (2-mm vs. 3-mm) and shapes (cylindrical abutment vs. concave abutment) on changes in the marginal bone level (bone loss and bone remodeling) in healthy, partially edentulous volunteer patients undergoing implant-supported rehabilitation.
The main questions it aims to answer are:
Read more
- Is there any difference in marginal bone loss for different abutment shapes and heights?
- Do the shape and height of the abutment affect implant success?
All participants will receive bone-level dental implants placed approximately 2-mm below the bone crest, each receiving a different type of abutment and researchers will see whether the shape and height of the abutment influence the success of the implant, periodontal probing depth (PPD), and bleeding on probing (BoP) comparing four groups of patients:
- 2-mm high abutments with cylindrical shape.
- 2-mm high abutments with concave shape.
- 3-mm high abutments with cylindrical shape.
- 3-mm high abutments with concave shape.
Clinical and radiographic assessments will be performed at abutment placement, at definitive prosthesis placement, and at 1, 3, 6, and 12 months after loading to measure marginal bone loss and peri-implant parameters.
- Conditions
- Dental Implant-Abutment Designs, Marginal Bone Loss in Different Abutment Designs, Soft Tissue Management in Subcrestal Dental Implants
- Being tested
- Bone-Level Implant Placement with Transmucosal Abutment and One Abutment-One Time Protocol
- Keywords
- dental implant, implant abutment, marginal bone loss, prostheses abutment width, prostheses abutment height
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone-Level Implant Placement with Transmucosal Abutment and One Abutment-One Time ProtocolProcedure or surgery
Participants will receive bone-level dental implants placed approximately 2 mm below the bone crest in a healed posterior site of the maxilla or mandible. The implants will be placed using biological drilling protocol and inserted with a final torque of at least 35 Ncm following the manufacturer's instructions . A transmucosal abutment according to the applicable randomization will be connected at the time of surgery with a final torque of at least 30 Ncm, following the "one abutment-one time" philosophy in order to avoid any changes in hard and soft peri-implant tissues.
| Study group | Role | What they receive |
|---|---|---|
| 2-mm high abutment with cylindrical shape | Experimental | Participants in this group will receive a 2-mm high abutment with cylindrical shape placed immediately after implant surgery. The abutment will remain in place throughout the healing period, following a one abutment-one time protocol. Receives: Procedure: Bone-Level Implant Placement with Transmucosal Abutment and One Abutment-One Time Protocol |
| 2-mm high abutment with concave shape | Experimental | Participants in this group will receive a 2-mm high abutment with concave shape placed immediately after implant surgery. The abutment will remain in place throughout the healing period, following a one abutment-one time protocol. Receives: Procedure: Bone-Level Implant Placement with Transmucosal Abutment and One Abutment-One Time Protocol |
| 3-mm high abutment with cylindrical shape | Experimental | Participants in this group will receive a 3-mm high abutment with cylindrical shape placed immediately after implant surgery. The abutment will remain in place throughout the healing period, following a one abutment-one time protocol. Receives: Procedure: Bone-Level Implant Placement with Transmucosal Abutment and One Abutment-One Time Protocol |
| 3-mm high abutment with concave shape | Experimental | Participants in this group will receive a 3-mm high abutment with concave shape placed immediately after implant surgery. The abutment will remain in place throughout the healing period, following a one abutment-one time protocol. Receives: Procedure: Bone-Level 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]), 3 months post-op (prosthetic loading) (T0), and at months 1 (T1), 3 (T3), 6 (T6), and 12 (T12) 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: 3 months post-op (prosthetic loading) (T0), and at months 1 (T1), 3 (T3), 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: 3 months post-op (prosthetic loading) (T0), and at months 1 (T1), 3 (T3), 6 (T6), and 12 (T12) after definitive prosthesis placement.
Implant success
Assessment of the implants will follow the criteria outlined by Misch et al. (2008) 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 posted3 Apr 2026
- Study start1 Jun 2026
- Primary completion31 Jul 2027 (estimated)
- Study completion30 Sep 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-Abutment DesignsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 180 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
- María I Suárez Antoima, DDS, Principal investigator, Universitat de València
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07509281
- Sponsor's protocol ID
- UV-INV-ETICA-3792382
- Status last verified
- Jun 2026
- First submitted
- 24 Mar 2026
- Last updated
- 5 Jun 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 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Supracrestal Soft Tissue on Peri-implant Bone Changes for Different Abutment Shapes and Heights: A Four-Arm Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07509281
- Acronym / sponsor ID
- UV-INV-ETICA-3792382
- Conditions
- Dental Implant-Abutment Designs, Marginal Bone Loss in Different Abutment Designs, Soft Tissue Management in Subcrestal Dental Implants
- Keywords
- dental implant, implant abutment, marginal bone loss, prostheses abutment width, prostheses abutment height
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 3 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 goal of this randomized clinical trial is to investigate the influence of supracrestal soft tissue on abutments of different heights (2-mm vs. 3-mm) and shapes (cylindrical abutment vs. concave abutment) on changes in the marginal bone level (bone loss and bone remodeling) in healthy, partially edentulous volunteer patients undergoing implant-supported rehabilitation.
The main questions it aims to answer are:
- Is there any difference in marginal bone loss for different abutment shapes and heights?
- Do the shape and height of the abutment affect implant success?
All participants will receive bone-level dental implants placed approximately 2-mm below the bone crest, each receiving a different type of abutment and researchers will see whether the shape and height of the abutment influence the success of the implant, periodontal probing depth (PPD), and bleeding on probing (BoP) comparing four groups of patients:
- 2-mm high abutments with cylindrical shape.
- 2-mm high abutments with concave shape.
- 3-mm high abutments with cylindrical shape.
- 3-mm high abutments with concave shape.
Clinical and radiographic assessments will be performed at abutment placement, at definitive prosthesis placement, and at 1, 3, 6, and 12 months after loading to measure marginal bone loss and peri-implant parameters.
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 high abutment with cylindrical shape | Experimental | Procedure: Bone-Level Implant Placement with Transmucosal Abutment and One Abutment-One Time ProtocolParticipants in this group will receive a 2-mm high abutment with cylindrical shape placed immediately after implant surgery. The abutment will remain in place throughout the healing period, following a one abutment-one time protocol. |
| 2-mm high abutment with concave shape | Experimental | Procedure: Bone-Level Implant Placement with Transmucosal Abutment and One Abutment-One Time ProtocolParticipants in this group will receive a 2-mm high abutment with concave shape placed immediately after implant surgery. The abutment will remain in place throughout the healing period, following a one abutment-one time protocol. |
| 3-mm high abutment with cylindrical shape | Experimental | Procedure: Bone-Level Implant Placement with Transmucosal Abutment and One Abutment-One Time ProtocolParticipants in this group will receive a 3-mm high abutment with cylindrical shape placed immediately after implant surgery. The abutment will remain in place throughout the healing period, following a one abutment-one time protocol. |
| 3-mm high abutment with concave shape | Experimental | Procedure: Bone-Level Implant Placement with Transmucosal Abutment and One Abutment-One Time ProtocolParticipants in this group will receive a 3-mm high abutment with concave shape placed immediately after implant surgery. The abutment will remain in place throughout the healing period, following a one abutment-one time protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adults aged 18 years or older.
- Posterior edentulism (premolars/molars).
- Good general and oral health, with controlled plaque and bleeding indices.
- Sufficient bone height and width for implant placement without the need for bone regeneration procedures. Patients who require indirect sinus lift procedure simultaneously with implant placement may be included in the study.
- Presence of at least 2 mm of keratinized mucosa around the dental implant.
Key exclusion criteria (4 listed)
- Presence of medical conditions that contraindicate implant surgery, such as heavy smoking (>10 cigarettes per day), severe bruxism, pregnancy or breastfeeding, bisphosphonate therapy, and patients undergoing chemotherapy or radiotherapy in the head and/or neck area.
- Active periodontal disease or peri-implant infection.
- Uncooperative patients or patients unable to complete follow- up.
- Implant failures.
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 |
|---|---|---|
| Bone-Level Implant Placement with Transmucosal Abutment and One Abutment-One Time ProtocolParticipants will receive bone-level dental implants placed approximately 2 mm below the bone crest in a healed posterior site of the maxilla or mandible. The implants will be placed using biological drilling protocol and inserted with a final torque of at least 35 Ncm following the manufacturer's instructions . A transmucosal abutment according to the applicable randomization will be connected at the time of surgery with a final torque of at least 30 Ncm, following the "one abutment-one time" philosophy in order to avoid any changes in hard and soft peri-implant tissues. | Procedure or surgery | 2-mm high abutment with concave shape, 2-mm high abutment with cylindrical shape, 3-mm high abutment with concave shape, 3-mm high abutment with cylindrical shape |
Primary outcome
Changes in peri-implant marginal bone level (mm)
Time frame: From abutment placement (baseline time [TB]), 3 months post-op (prosthetic loading) (T0), and at months 1 (T1), 3 (T3), 6 (T6), and 12 (T12) 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: 3 months post-op (prosthetic loading) (T0), and at months 1 (T1), 3 (T3), 6 (T6), and 12 (T12) after definitive prosthesis placement.
Bleeding on probing (presence/absence)
Time frame: 3 months post-op (prosthetic loading) (T0), and at months 1 (T1), 3 (T3), 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 5 Jun 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.
María I Suárez Antoima, DDS principal investigator
Universitat de València
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bone-Level Implant Placement with Transmucosal Abutment and One Abutment-One Time Protocol in people with Dental Implant-Abutment Designs and Marginal Bone Loss in Different Abutment Designs, 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 8 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 5 Jun 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?
Contact Juan C Bernabeu Mira, DDS, MSc, PhD (+34 697348312, juan.c.bernabeu@uv.es), or a site near the patient. 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]), 3 months post-op (prosthetic loading) (T0), and at months 1 (T1), 3 (T3), 6 (T6), and 12 (T12) 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 5 Jun 2026.