Jaw, Edentulous, Partially213CEIH2016NCT02975674
Evaluation of MT-12 Implant Survival and Marginal Bone Loss
A study testing MT-12 dental implant and CON.INT dental implant in people with Jaw, Edentulous, Partially, run by Universidad de Granada at 1 site in Spain.
Trial summary
The trial is designed as a consecutive enrollment prospective one-center study. A minimum of 30 patients will be included in the study. At implant installation, the patient will be randomized to receive one of the two types of implants (Control: internal hexagon connection implants (CON.INT); Test: Morse taper… 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?
- MT-12 dental implant and CON.INT dental implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- Nov 2016to Feb 2021
- 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
- Patient >18 and ≤75 years old
- 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
Show all 13Show fewer
- 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
The trial is designed as a consecutive enrollment prospective one-center study. A minimum of 30 patients will be included in the study. At implant installation, the patient will be randomized to receive one of the two types of implants (Control: internal hexagon connection implants (CON.INT); Test: Morse taper connection implants (MT-12)). Samples of peri-implant crevicular fluid (PICF) and intrasulcular plaque will be collected at -21 (second-stage surgery), -14 (impressions), 0 (Baseline: prosthesis delivery), 7 days and 1, 3, 6, 12 months. Prosthesis will be fabricated and delivered as usual, i.e., approximately two weeks after the impressions are taken.
- Conditions
- Jaw, Edentulous, Partially
- Being tested
- MT-12 dental implant, CON.INT dental implant
- 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.
MT-12 dental implantDevice
Placement of the MT-12 dental implant with Morse taper implant-abutment connection
CON.INT dental implantDevice
Placement of the CON.INT dental implant with internal hexagon implant-abutment connection
| Study group | Role | What they receive |
|---|---|---|
| MT-12 dental implant | Experimental | MT-12 dental implant with Morse taper implant-abutment connection Receives: Device: MT-12 dental implant |
| CON.INT dental implant | Active comparator | CON.INT dental implant with internal hexagon implant-abutment connection Receives: Device: CON.INT dental implant |
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 inflammation
Measured: 1 year
Peri-implant microbial contamination
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 posted29 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionFeb 2021
- Study completionFeb 2021
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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pablo Galindo-Moreno, Universidad de Granada
- Investigators
- Pablo Galindo-Moreno, DDS, PhD, Principal investigator, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02975674
- Sponsor's protocol ID
- 213CEIH2016
- Acronym
- 213CEIH2016
- Status last verified
- May 2023
- First submitted
- 23 Nov 2016
- Last updated
- 23 May 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Galindo-Moreno P, Fernandez-Jimenez A, O'Valle F, Monje A, Silvestre FJ, Juodzbalys G, Sanchez-Fernandez E, Catena A. Influence of the crown-implant connection on the preservation of peri-implant bone: a retrospective multifactorial analysis. Int J Oral Maxillofac Implants. 2015 Mar-Apr;30(2):384-90. doi: 10.11607/jomi.3804.
PubMed 25830399Galindo-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 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of MT-12 Implant Survival and Marginal Bone Loss
- ClinicalTrials.gov ID
- NCT02975674
- Acronym / sponsor ID
- 213CEIH2016 / 213CEIH2016
- Conditions
- Jaw, Edentulous, Partially
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- Feb 2021 (actual)
- Study completion
- Feb 2021 (actual)
- First posted
- 29 Nov 2016 (estimated)
- 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 trial is designed as a consecutive enrollment prospective one-center study. A minimum of 30 patients will be included in the study. At implant installation, the patient will be randomized to receive one of the two types of implants (Control: internal hexagon connection implants (CON.INT); Test: Morse taper connection implants (MT-12)). Samples of peri-implant crevicular fluid (PICF) and intrasulcular plaque will be collected at -21 (second-stage surgery), -14 (impressions), 0 (Baseline: prosthesis delivery), 7 days and 1, 3, 6, 12 months. Prosthesis will be fabricated and delivered as usual, i.e., approximately two weeks after the impressions are taken.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MT-12 dental implant | Experimental | Device: MT-12 dental implantMT-12 dental implant with Morse taper implant-abutment connection |
| CON.INT dental implant | Active comparator | Device: CON.INT dental implantCON.INT dental implant with internal hexagon implant-abutment connection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient >18 and ≤75 years old
- 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 |
|---|---|---|
| MT-12 dental implantPlacement of the MT-12 dental implant with Morse taper implant-abutment connection | Device | MT-12 dental implant |
| CON.INT dental implantPlacement of the CON.INT dental implant with internal hexagon implant-abutment connection | Device | CON.INT dental implant |
Primary outcome
Marginal bone level
Time frame: 1 year
2 secondary outcomes
Peri-implant inflammation
Time frame: 1 year
Peri-implant microbial contamination
Time frame: 1 year
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 23 May 2023.
- Background: PubMed 25830399Galindo-Moreno P, Fernandez-Jimenez A, O'Valle F, Monje A, Silvestre FJ, Juodzbalys G, Sanchez-Fernandez E, Catena A. Influence of the crown-implant connection on the preservation of peri-implant bone: a retrospective multifactorial analysis. Int J Oral Maxillofac Implants. 2015 Mar-Apr;30(2):384-90. doi: 10.11607/jomi.3804.
- Results publication: 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.
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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.
Pablo Galindo-Moreno, DDS, PhD principal investigator
Universidad de Granada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MT-12 dental implant and CON.INT dental implant 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 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: finished, as of the sponsor's last update on 23 May 2023. 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?
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?
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 NCT02975674, 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 23 May 2023.