Jaw, Edentulous, PartiallyNCT05883202
Effect of the Abutment-Prosthesis Connection on Marginal Bone Loss and Gingival Sealing Around Dental Implants
A study testing Connect® and Multi-unit in people with Jaw, Edentulous, Partially, run by Universidad de Granada at 1 site in Spain.
Trial summary
In dental implant restoration, available literature demonstrates the advantage of using tall abutments, with a change of diameter with respect to the implant and a conical internal connection in the abutment-implant gap. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Jaw, Edentulous, Partially
- What is being tested?
- Connect® and Multi-unit
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 10 Jul 2023to Jul 2026
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Kennedy class I or II (unilateral or bilateral free end) or III (posterior intermediate edentulous section) mandibular requiring 2 implants to restore at least 2 molars, 2 molars and 1 premolar, or 2 premolars and 1 molar.
- Possibility of placing a transgingival abutment at least 2 mm high.
Who cannot join
- Need for simultaneous bone augmentation.
- Heavy smokers (>10 cigarettes/day).
- Uncontrolled type 1 or 2 diabetes (HgA1c>8).
- Known autoimmune or inflammatory disease.
- Serious blood disorders, such as hemophilia or leukemia.
- Local or systemic infection that may compromise normal healing (e.g., extensive periapical pathology).
Show all 14Show fewer
- Liver or kidney dysfunction/failure.
- Currently receiving cancer treatment or within 18 months from completion of radio- or chemotherapy.
- Long-term history of oral bisphosphonates use (i.e., 10 years or more).
- History of intravenous bisphosphonates.
- Long-term (>3 months) history of antibiotics or drugs known to alter the inflammation and/or immunological system 3 months before inclusion.
- Severe osseous diseases (e.g., Paget disease of bone).
- Pregnant women or nursing mothers.
- Not able or not willing to follow instructions related to the study procedures.
Trial locations and contacts
1 site in 1 country.
About this study
In dental implant restoration, available literature demonstrates the advantage of using tall abutments, with a change of diameter with respect to the implant and a conical internal connection in the abutment-implant gap. However, for multiple restorations, the abutment-prosthesis connection has not been studied in detail. The "multi-unit" systems, both standard and brand specific, have either a flat or butt joint or an cone. In any case, both are external connection systems. Recently, an internal-type abutment-prosthesis connection system has been developed. Although it is proving its usefulness in single restorations, its use in multiple restorations compared to traditional systems has not been studied.
Therefore, taking into account all of the above, the present study has the overall objective of analyzing marginal bone loss (MBL) and adaptation of soft tissues by comparing a multiple prosthesis system of the "external, flat" type versus an external system of the "internal, conical" type.
- Conditions
- Jaw, Edentulous, Partially
- Being tested
- Connect®, Multi-unit
- Medical subject headings
- Jaw, Edentulous, Partially
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Connect®Device
Restoration of multiple implants with a Connect® abutment between the implant and the prosthesis.
Multi-unitDevice
Restoration of multiple implants with a conventional multi-unit abutment between the implant and the prosthesis.
| Study group | Role | What they receive |
|---|---|---|
| Connect® | Experimental | Restoration of multiple implants with a Connect® abutment between the implant and the prosthesis. Receives: Device: Connect® |
| Multi-unit | Active comparator | Restoration of multiple implants with a conventional multi-unit abutment between the implant and the prosthesis. Receives: Device: Multi-unit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal bone level
Peri-implant marginal bone level measured by standardized periapical radiography
Measured: 1 year
Secondary outcomes (2)
Peri-implant microbiome
Relative abundance of microbial species in the peri-implant sulcus evaluated by next-generation sequencing methods
Measured: 1 year
Peri-implant inflammation
Concentration of pro-inflammatory markers in the peri-implant sulcus evaluated by multiplex techniques methods
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study start10 Jul 2023
- Primary completionMay 2026 (estimated)
- Study completionJul 2026 (estimated)
Why it stopped: No researcher available to conduct the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Jaw, Edentulous, PartiallyStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miguel Padial-Molina, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05883202
- Sponsor's protocol ID
- 2622CEIH2022
- Status last verified
- May 2026
- First submitted
- 20 May 2023
- Last updated
- 12 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Galindo-Moreno P, Leon-Cano A, Ortega-Oller I, Monje A, Suarez F, OValle F, Spinato S, Catena A. Prosthetic Abutment Height is a Key Factor in Peri-implant Marginal Bone Loss. J Dent Res. 2014 Jul;93(7 Suppl):80S-85S. doi: 10.1177/0022034513519800. Epub 2014 Mar 12.
PubMed 24621670Couso-Queiruga E, Tattan M, Ahmad U, Barwacz C, Gonzalez-Martin O, Avila-Ortiz G. Assessment of gingival thickness using digital file superimposition versus direct clinical measurements. Clin Oral Investig. 2021 Apr;25(4):2353-2361. doi: 10.1007/s00784-020-03558-0. Epub 2020 Aug 31.
PubMed 32865627
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Abutment-Prosthesis Connection on Marginal Bone Loss and Gingival Sealing Around Dental Implants
- ClinicalTrials.gov ID
- NCT05883202
- Acronym / sponsor ID
- 2622CEIH2022
- Conditions
- Jaw, Edentulous, Partially
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: No researcher available to conduct the study.
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- 10 Jul 2023 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 31 May 2023 (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.
In dental implant restoration, available literature demonstrates the advantage of using tall abutments, with a change of diameter with respect to the implant and a conical internal connection in the abutment-implant gap. However, for multiple restorations, the abutment-prosthesis connection has not been studied in detail. The "multi-unit" systems, both standard and brand specific, have either a flat or butt joint or an cone. In any case, both are external connection systems. Recently, an internal-type abutment-prosthesis connection system has been developed. Although it is proving its usefulness in single restorations, its use in multiple restorations compared to traditional systems has not been studied.
Therefore, taking into account all of the above, the present study has the overall objective of analyzing marginal bone loss (MBL) and adaptation of soft tissues by comparing a multiple prosthesis system of the "external, flat" type versus an external system of the "internal, conical" type.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Connect® | Experimental | Device: Connect®Restoration of multiple implants with a Connect® abutment between the implant and the prosthesis. |
| Multi-unit | Active comparator | Device: Multi-unitRestoration of multiple implants with a conventional multi-unit abutment between the implant and the prosthesis. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Kennedy class I or II (unilateral or bilateral free end) or III (posterior intermediate edentulous section) mandibular requiring 2 implants to restore at least 2 molars, 2 molars and 1 premolar, or 2 premolars and 1 molar.
- Possibility of placing a transgingival abutment at least 2 mm high.
Key exclusion criteria (14 listed)
- Need for simultaneous bone augmentation.
- Heavy smokers (>10 cigarettes/day).
- Uncontrolled type 1 or 2 diabetes (HgA1c>8).
- Known autoimmune or inflammatory disease.
- Serious blood disorders, such as hemophilia or leukemia.
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 |
|---|---|---|
| Connect®Restoration of multiple implants with a Connect® abutment between the implant and the prosthesis. | Device | Connect® |
| Multi-unitRestoration of multiple implants with a conventional multi-unit abutment between the implant and the prosthesis. | Device | Multi-unit |
Primary outcome
Marginal bone level
Time frame: 1 year
Peri-implant marginal bone level measured by standardized periapical radiography
2 secondary outcomes
Peri-implant microbiome
Time frame: 1 year
Peri-implant inflammation
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Background: PubMed 24621670Galindo-Moreno P, Leon-Cano A, Ortega-Oller I, Monje A, Suarez F, OValle F, Spinato S, Catena A. Prosthetic Abutment Height is a Key Factor in Peri-implant Marginal Bone Loss. J Dent Res. 2014 Jul;93(7 Suppl):80S-85S. doi: 10.1177/0022034513519800. Epub 2014 Mar 12.
- Background: PubMed 32865627Couso-Queiruga E, Tattan M, Ahmad U, Barwacz C, Gonzalez-Martin O, Avila-Ortiz G. Assessment of gingival thickness using digital file superimposition versus direct clinical measurements. Clin Oral Investig. 2021 Apr;25(4):2353-2361. doi: 10.1007/s00784-020-03558-0. Epub 2020 Aug 31.
- Individual participant dataSharing planned: No
Related trials for Jaw, Edentulous, Partially
Active, not recruiting
L-PRF Block vs Composite Graft for Horizontal Ridge Augmentation
Alveolar Ridge Resorption After Extraction, Alveolar Bone Loss
Not yet recruitingObservational study
Digital and Conventional Clasp-retained Partial Dentures (DIGICLASP)
Partial Edentulism
Active, not recruiting
Multicenter Study to Evaluate the Clinical Outcome of PrimeTaper EV Implant in Single Tooth Restorations
Jaw, Edentulous, Partially
Recruiting
Clinical and Radiographic Evaluation of UV-Treated Dental Implants With or Without Melatonin in the Upper Posterior Jaw
Jaw, Edentulous, Partially, Bone Resorption
Active, not recruiting
A Clinical Study on Acuris™ - Conometric Concept for Single Tooth Restoration
Jaw, Edentulous, Partially
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Connect® and Multi-unit in people with Jaw, Edentulous, Partially, run by Universidad de Granada 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 2 inclusion and 14 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: paused, as of the sponsor's last update on 12 May 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?
Results are not available in the source record.
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?
Marginal bone level (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05883202, which also lists 2 linked publications.
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 12 May 2026.