Bone LossNCT06629961
Impact of Transepithelial Abutment Connection and Disconnection in Dental Implants
A study testing abutment placement and Ti-base placement in people with Bone Loss and Bacterium; Agent, run by University of Valencia at 2 sites in Spain.
Trial summary
Over the past decade, implant research has focused on maintaining the health and stability of peri-implant tissues. A key factor is platform switching at the bone level, where a narrower abutment than the implant is used. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bone Loss, Bacterium; Agent, Satisfaction, Patient
- What is being tested?
- abutment placement and Ti-base placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesSpain
- Study dates
- 1 Nov 2024to 1 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy partially edentulous adult patients needing at least two implants for the placement of single or consecutive crowns in the posterior mandible or maxilla will be recruited.
- These patients should exhibit a plaque index and gingival bleeding index of less than 25%, and have sufficient bone height and width for the placement of dental implants measuring 8 or 10 mm in length and 3.5 or 4 mm in diameter.
- Additionally, they must have at least 2 mm of keratinized vestibular gingiva, stable occlusion, and a periodontium in good health
Who cannot join
- Edentulous areas requiring bone grafts will be excluded.
- Patients with medical conditions contraindicating implant surgery, such as severe bruxism or inadequate oral hygiene.
- Pregnant or lactating women, patients undergoing bisphosphonate therapy, those receiving chemotherapy or radiotherapy in the head and neck area, non-compliant patients with incomplete data records, and those who do not attend regular follow-up appointments will also be excluded.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Clínica Odontológica de la Universitat de Valencia, Fundación Lluis Alcanyis
Valencia, 46010
Facultad de Medicina y Odontología de la Universitat de València
Valencia, 46010
About this study
Official title: Impact of Connection and Disconnection of the Transepithelial Abutment in Dental Implants
Over the past decade, implant research has focused on maintaining the health and stability of peri-implant tissues. A key factor is platform switching at the bone level, where a narrower abutment than the implant is used. This technique increases the implant's horizontal surface area for biological width establishment and reduces stress on the crestal bone.
Studies showed that repeated disconnection and reconnection of prosthetic components could compromise the mucosal barrier around implants, leading to an apical shift in the connective tissue junction and vertical tissue loss. This led to the "one abutment, one time" protocol, advocating the placement of the definitive abutment during initial implant surgery to avoid its removal during healing.
Read more
A recent meta-analysis indicated bone loss at the marginal level due to abutment connection and disconnection, despite different treatment protocols. Thus, a standardized abutment between the fixed prosthesis and the implant has been recommended to preserve marginal bone levels. This approach moves the biological width apically, protecting the bone from irritation and improving marginal bone isolation.
However, comparative evidence between direct implant-connected prostheses and trans-epithelial abutments is lacking. This study aims to evaluate the "one abutment, one time" protocol's effect on bone loss 12 months after prosthesis placement.
Secondary objectives include assessing patient satisfaction using Patient-Reported Outcome Measures (PROM) during prosthesis fabrication and placement, and obtaining information on the diversity and function of microorganisms on the implant using metagenomic techniques 12 months post-prosthesis placement.
Throughout the prosthesis fabrication and the first 12 months, various evaluations will be conducted in both abutment and Ti-base groups:
- Bleeding: Recorded during various prosthetic stages.
- Pain: Assessed using a visual analog scale after each stage.
- Anesthesia: Recorded if used at each stage.
- Radiographs: Number taken to check the fit.
- Time: Measured for each prosthetic phase.
- Repetitions: Number of repeated procedures quantified.
- Metagenomic tests: Samples collected following the Human Microbiome Project protocol to analyze microbial diversity and function.
- Conditions
- Bone Loss, Bacterium; Agent, Satisfaction, Patient
- Being tested
- abutment placement, Ti-base placement
- Keywords
- bone loss, bacteria, dental implant, satisfaction
- Medical subject headings
- Bone Diseases, Metabolic, Patient Satisfaction, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
abutment placementProcedure or surgery
Placement of a subcrestal implant at more than 35 N and placement of a trans-epithelial abutment at 30 N
Ti-base placementProcedure or surgery
Placement of a subcrestal implant at more than 35 N and placement of a Tibase placement at 30 N
| Study group | Role | What they receive |
|---|---|---|
| Abutment Group | Experimental | The patients in this group will undergo implant placement surgery using the conventional technique, which will include a full-thickness flap, biological drilling, and sub-crestal implant placement at 2 mm below the crest level. Since this is the Pilar group (Galimplant aesthetic straight abutment, NUEVAGALIMPANT), a 3 mm abutment will be placed during the same procedure, secured with a torque of 30 N. A healing cap will be applied and maintained until the osseointegration process is completed after three months.
After three months, this group will receive a cement-retained and screw-retained zirconia prosthesis, which will be placed over the previously installed abutment. The crown screw will be torqued to 25 N. Receives: Procedure: abutment placement |
| ti-base Group | Experimental | The patients in this group will undergo implant placement surgery using the conventional technique, which will include a full-thickness flap, biological drilling, and sub-crestal implant placement at 2 mm below the crest level. Since this is the Tibase group (3 mm Tibase from Galimplant, NUEVAGALIMPANT), submerged healing will be performed with a healing cap connected to the implant, which will remain in place until the osseointegration process is completed after three months.
After three months of osseointegration, a prosthesis will be placed directly connected to the implant platform via the 3 mm Tibase. The screw will be tightened to 30 N. Receives: Procedure: Ti-base placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
periimplant marginal bone loss
The peri-implant marginal bone level was measured using Image J software from the National Institutes of Health with an accuracy of 0.1 mm. A straight line was drawn at the implant platform level (representing zero height), and perpendicular lines were drawn from the mesial and distal sides of the platform to measure the distance to the bone level on each side
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start1 Nov 2024
- Primary completion1 Nov 2025
- Study completion1 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone LossStudies 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Peñarrocha Oltra, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06629961
- Sponsor's protocol ID
- 3395885
- Status last verified
- Jul 2026
- First submitted
- 31 Jul 2024
- Last updated
- 13 Jul 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 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Connection and Disconnection of the Transepithelial Abutment in Dental Implants
- ClinicalTrials.gov ID
- NCT06629961
- Acronym / sponsor ID
- 3395885
- Conditions
- Bone Loss, Bacterium; Agent, Satisfaction, Patient
- Keywords
- bone loss, bacteria, dental implant, satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 1 Nov 2025 (actual)
- First posted
- 8 Oct 2024 (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.
Over the past decade, implant research has focused on maintaining the health and stability of peri-implant tissues. A key factor is platform switching at the bone level, where a narrower abutment than the implant is used. This technique increases the implant's horizontal surface area for biological width establishment and reduces stress on the crestal bone.
Studies showed that repeated disconnection and reconnection of prosthetic components could compromise the mucosal barrier around implants, leading to an apical shift in the connective tissue junction and vertical tissue loss. This led to the "one abutment, one time" protocol, advocating the placement of the definitive abutment during initial implant surgery to avoid its removal during healing.
A recent meta-analysis indicated bone loss at the marginal level due to abutment connection and disconnection, despite different treatment protocols. Thus, a standardized abutment between the fixed prosthesis and the implant has been recommended to preserve marginal bone levels. This approach moves the biological width apically, protecting the bone from irritation and improving marginal bone isolation.
However, comparative evidence between direct implant-connected prostheses and trans-epithelial abutments is lacking. This study aims to evaluate the "one abutment, one time" protocol's effect on bone loss 12 months after prosthesis placement.
Secondary objectives include assessing patient satisfaction using Patient-Reported Outcome Measures (PROM) during prosthesis fabrication and placement, and obtaining information on the diversity and function of microorganisms on the implant using metagenomic techniques 12 months post-prosthesis placement.
Throughout the prosthesis fabrication and the first 12 months, various evaluations will be conducted in both abutment and Ti-base groups:
- Bleeding: Recorded during various prosthetic stages.
- Pain: Assessed using a visual analog scale after each stage.
- Anesthesia: Recorded if used at each stage.
- Radiographs: Number taken to check the fit.
- Time: Measured for each prosthetic phase.
- Repetitions: Number of repeated procedures quantified.
- Metagenomic tests: Samples collected following the Human Microbiome Project protocol to analyze microbial diversity and function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Abutment Group | Experimental | Procedure: abutment placementThe patients in this group will undergo implant placement surgery using the conventional technique, which will include a full-thickness flap, biological drilling, and sub-crestal implant placement at 2 mm below the crest level. Since this is the Pilar group (Galimplant aesthetic straight abutment, NUEVAGALIMPANT), a 3 mm abutment will be placed during the same procedure, secured with a torque of 30 N. A healing cap will be applied and maintained until the osseointegration process is completed after three months. After three months, this group will receive a cement-retained and screw-retained zirconia prosthesis, which will be placed over the previously installed abutment. The crown screw will be torqued to 25 N. |
| ti-base Group | Experimental | Procedure: Ti-base placementThe patients in this group will undergo implant placement surgery using the conventional technique, which will include a full-thickness flap, biological drilling, and sub-crestal implant placement at 2 mm below the crest level. Since this is the Tibase group (3 mm Tibase from Galimplant, NUEVAGALIMPANT), submerged healing will be performed with a healing cap connected to the implant, which will remain in place until the osseointegration process is completed after three months. After three months of osseointegration, a prosthesis will be placed directly connected to the implant platform via the 3 mm Tibase. The screw will be tightened to 30 N. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy partially edentulous adult patients needing at least two implants for the placement of single or consecutive crowns in the posterior mandible or maxilla will be recruited.
- These patients should exhibit a plaque index and gingival bleeding index of less than 25%, and have sufficient bone height and width for the placement of dental implants measuring 8 or 10 mm in length and 3.5 or 4 mm in diameter.
- Additionally, they must have at least 2 mm of keratinized vestibular gingiva, stable occlusion, and a periodontium in good health
Key exclusion criteria (3 listed)
- Edentulous areas requiring bone grafts will be excluded.
- Patients with medical conditions contraindicating implant surgery, such as severe bruxism or inadequate oral hygiene.
- Pregnant or lactating women, patients undergoing bisphosphonate therapy, those receiving chemotherapy or radiotherapy in the head and neck area, non-compliant patients with incomplete data records, and those who do not attend regular follow-up appointments will also be excluded.
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 |
|---|---|---|
| abutment placementPlacement of a subcrestal implant at more than 35 N and placement of a trans-epithelial abutment at 30 N | Procedure or surgery | Abutment Group |
| Ti-base placementPlacement of a subcrestal implant at more than 35 N and placement of a Tibase placement at 30 N | Procedure or surgery | ti-base Group |
Primary outcome
periimplant marginal bone loss
Time frame: 12 months
The peri-implant marginal bone level was measured using Image J software from the National Institutes of Health with an accuracy of 0.1 mm. A straight line was drawn at the implant platform level (representing zero height), and perpendicular lines were drawn from the mesial and distal sides of the platform to measure the distance to the bone level on each side
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing abutment placement and Ti-base placement in people with Bone Loss and Bacterium; Agent, run by University of Valencia at 2 sites 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 3 inclusion and 3 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: finished, 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 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
periimplant marginal bone loss (time frame: 12 months). 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.