Jaw, Edentulous, PartiallyNCT05859113
Evaluation of Marginal Bone Loss and Associated Factors Around Ziacom Dental Implants With Different Prosthetic Connection
A study testing Ziacom Galaxy dental implant with internal connical prosthetic connection and Ziacom Zinic dental implant with internal hexagonal prosthetic connection in people with Jaw, Edentulous, Partially, run by Universidad de Granada at 1 site in Spain.
Trial summary
Dental implants may suffer from bone loss around them, particularly at the upper portion where the prosthesis starts. The connection between both parts of the tooth restoration is key for avoiding micromovement during chewing, bacterial contamination and initiation of bone loss. 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?
- Ziacom Galaxy dental implant with internal connical prosthetic connection and Ziacom Zinic dental implant with internal hexagonal prosthetic connection
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteSpain
- Study dates
- 10 Jul 2023to Dec 2026
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- One missing tooth in the premolar or molar area with both opposing and adjacent teeth (mesial and distal).
Who cannot join
- One-stage bone augmentation.
- Uncontrolled type 1 or 2 diabetes (HgA1c>8).
- Known auto-immune or inflammatory disease.
- Severe hematologic disorders, such as hemophilia or leukemia.
- Local or systemic infection that may compromise normal healing (e.g., extensive periapical pathology).
- Liver or kidney dysfunction/failure.
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- 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
Dental implants may suffer from bone loss around them, particularly at the upper portion where the prosthesis starts. The connection between both parts of the tooth restoration is key for avoiding micromovement during chewing, bacterial contamination and initiation of bone loss. Thus, investigating factors related to this bone loss in different types of implant-prosthetic connections is key for promoting better use of available therapeutics devices. In this study, we will study marginal bone levels over time as well as bacterial contamination and inflammatory markers in the peri-implant sulcus around implants with connical connection and compare them with those obtained when using implants with internal hexagonal connection. The hypothesis is that bone loss will be higher in implants with hexagonal connection associated with a pathological microbiome in the sulcus that induces a higher inflammatory response.
- Conditions
- Jaw, Edentulous, Partially
- Being tested
- Ziacom Galaxy dental implant with internal connical prosthetic connection, Ziacom Zinic dental implant with internal hexagonal prosthetic connection
- 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.
Ziacom Galaxy dental implant with internal connical prosthetic connectionDevice
Placement and restoration of a single Ziacom Galaxy dental implant with internal connical prosthetic connection
Ziacom Zinic dental implant with internal hexagonal prosthetic connectionDevice
Placement and restoration of a single Ziacom Zinic dental implant with internal hexagonal prosthetic connection
| Study group | Role | What they receive |
|---|---|---|
| Ziacom Galaxy dental implant with internal connical prosthetic connection | Experimental | Placement and restoration of a single Ziacom Galaxy dental implant with internal connical prosthetic connection Receives: Device: Ziacom Galaxy dental implant with internal connical prosthetic connection |
| Ziacom Zinic dental implant with internal hexagonal prosthetic connection | Active comparator | Placement and restoration of a single Ziacom Zinic dental implant with internal hexagonal prosthetic connection Receives: Device: Ziacom Zinic dental implant with internal hexagonal prosthetic connection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal bone level
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 posted15 May 2023
- Study start10 Jul 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- 42 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
- NCT05859113
- Sponsor's protocol ID
- 2978/CEIH/2022
- Status last verified
- May 2026
- First submitted
- 2 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, Concha-Jeronimo A, Lopez-Chaichio L, Rodriguez-Alvarez R, Sanchez-Fernandez E, Padial-Molina M. Marginal Bone Loss around Implants with Internal Hexagonal and Internal Conical Connections: A 12-Month Randomized Pilot Study. J Clin Med. 2021 Nov 20;10(22):5427. doi: 10.3390/jcm10225427.
PubMed 34830709
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
- Evaluation of Marginal Bone Loss and Associated Factors Around Ziacom Dental Implants With Different Prosthetic Connection
- ClinicalTrials.gov ID
- NCT05859113
- Acronym / sponsor ID
- 2978/CEIH/2022
- Conditions
- Jaw, Edentulous, Partially
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- 10 Jul 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 15 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.
Dental implants may suffer from bone loss around them, particularly at the upper portion where the prosthesis starts. The connection between both parts of the tooth restoration is key for avoiding micromovement during chewing, bacterial contamination and initiation of bone loss. Thus, investigating factors related to this bone loss in different types of implant-prosthetic connections is key for promoting better use of available therapeutics devices. In this study, we will study marginal bone levels over time as well as bacterial contamination and inflammatory markers in the peri-implant sulcus around implants with connical connection and compare them with those obtained when using implants with internal hexagonal connection. The hypothesis is that bone loss will be higher in implants with hexagonal connection associated with a pathological microbiome in the sulcus that induces a higher inflammatory response.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ziacom Galaxy dental implant with internal connical prosthetic connection | Experimental | Device: Ziacom Galaxy dental implant with internal connical prosthetic connectionPlacement and restoration of a single Ziacom Galaxy dental implant with internal connical prosthetic connection |
| Ziacom Zinic dental implant with internal hexagonal prosthetic connection | Active comparator | Device: Ziacom Zinic dental implant with internal hexagonal prosthetic connectionPlacement and restoration of a single Ziacom Zinic dental implant with internal hexagonal prosthetic connection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- One missing tooth in the premolar or molar area with both opposing and adjacent teeth (mesial and distal).
Key exclusion criteria (13 listed)
- One-stage bone augmentation.
- Uncontrolled type 1 or 2 diabetes (HgA1c>8).
- Known auto-immune or inflammatory disease.
- Severe hematologic disorders, such as hemophilia or leukemia.
- Local or systemic infection that may compromise normal healing (e.g., extensive periapical pathology).
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 |
|---|---|---|
| Ziacom Galaxy dental implant with internal connical prosthetic connectionPlacement and restoration of a single Ziacom Galaxy dental implant with internal connical prosthetic connection | Device | Ziacom Galaxy dental implant with internal connical prosthetic connection |
| Ziacom Zinic dental implant with internal hexagonal prosthetic connectionPlacement and restoration of a single Ziacom Zinic dental implant with internal hexagonal prosthetic connection | Device | Ziacom Zinic dental implant with internal hexagonal prosthetic connection |
Primary outcome
Marginal bone level
Time frame: 1 year
2 secondary outcomes
Peri-implant microbiome
Time frame: 1 year
Peri-implant inflammation
Time frame: 1 year
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 12 May 2026.
- Background: PubMed 34830709Galindo-Moreno P, Concha-Jeronimo A, Lopez-Chaichio L, Rodriguez-Alvarez R, Sanchez-Fernandez E, Padial-Molina M. Marginal Bone Loss around Implants with Internal Hexagonal and Internal Conical Connections: A 12-Month Randomized Pilot Study. J Clin Med. 2021 Nov 20;10(22):5427. doi: 10.3390/jcm10225427.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ziacom Galaxy dental implant with internal connical prosthetic connection and Ziacom Zinic dental implant with internal hexagonal prosthetic connection 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 1 inclusion and 13 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 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?
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?
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 NCT05859113, which also lists 1 linked publication.
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.