Edentulous; Alveolar Process, AtrophyNCT05284461
Effect of Shape and Surface Treatment of the Transmucosal Abutments on Peri-implant Health.
A study testing dental implant with transepithelial abutments manufactured by Galimplant Dental System (Spain) in people with Edentulous; Alveolar Process, Atrophy, run by University of Salamanca at 1 site in Spain.
Trial summary
The sample was comprised by 10 patients in which 40 dental implants are placed in an atrophic maxilla. All the implants were connected to 4 types of transepithelial abutment: i.e: parallel anodized abutment(n=10); parallel mechanized abutmen(n=10)t, convergent anodized abutment(n=10); and convergent mechanized… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Edentulous; Alveolar Process, Atrophy
- What is being tested?
- dental implant with transepithelial abutments manufactured by Galimplant Dental System (Spain)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteSpain
- Study dates
- 1 May 2020to 1 Sep 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- totally edentulous patients in the upper arch and carriers of conventional complete dentures for more than ten years, without temporomandibular disorders
Who cannot join
- evidence of systemic or psychic pathology that contraindicates implant treatment.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Clinica Odontológica de la Universidad de Salamanca
Salamanca, 37007
About this study
Official title: Effect of Shape and Surface Treatment of the Transmucosal Abutments on the Bone-implant-contact and the Peri-implant Health, .
The sample was comprised by 10 patients in which 40 dental implants are placed in an atrophic maxilla. All the implants were connected to 4 types of transepithelial abutment: i.e: parallel anodized abutment(n=10); parallel mechanized abutmen(n=10)t, convergent anodized abutment(n=10); and convergent mechanized abutment (n=10) three months after insertion implants were extracted with the surrounding hard and soft tissues for the histological evaluation of the clinical performance.
- Conditions
- Edentulous; Alveolar Process, Atrophy
- Being tested
- dental implant with transepithelial abutments manufactured by Galimplant Dental System (Spain)
- Medical subject headings
- Mouth, Edentulous, Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dental implant with transepithelial abutments manufactured by Galimplant Dental System (Spain)Device
Dental implants with transepithelial abutments with distinct morphology
| Study group | Role | What they receive |
|---|---|---|
| Mechanized parallel abutments | Placebo comparator | Implants were immediately covered with this type of abutments after insertion. This is the most common procedure. It would be the gold standard Receives: Device: dental implant with transepithelial abutments manufactured by Galimplant Dental System (Spain) |
| Anodized parallel abutments | Experimental | Implants were immediately covered with this kind of abutments after insertion. Only the surface treatment varies to the gold standard Receives: Device: dental implant with transepithelial abutments manufactured by Galimplant Dental System (Spain) |
| Mechanized convergent abutments | Experimental | Implants were immediately covered with this kind of abutments after insertion. Only the geometry of the emergence profile varies with regards to the gold standard Receives: Device: dental implant with transepithelial abutments manufactured by Galimplant Dental System (Spain) |
| Anodized convergent abutments | Experimental | Implants were immediately covered with this kind of abutments after insertion. Both the surface treatment and the geometry vary with regards to the gold standard Receives: Device: dental implant with transepithelial abutments manufactured by Galimplant Dental System (Spain) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone to implant contact
It is a Percentage estimation of native bone in direct contact to implant determined by histological assessments (optical microscopy)
Measured: 3 months after healing
Peri-implant inflammation of the soft tissues
Histological assessments as ordinal variables of the grade of inflammatory infiltrate (none, minor, major)according to standard guidelines.
Measured: 3 months after healing
Density of the peri-implant soft tissues
Histological assessments as ordinal variables of the density of the collagen fibers (low, medium, high) according to standard guidelines.
Measured: 3 months after healing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start1 May 2020
- Primary completion1 Jan 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edentulous; Alveolar Process, AtrophyStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Salamanca
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JAVIER MONTERO, University of Salamanca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05284461
- Sponsor's protocol ID
- USAL_2021_JMONT
- Status last verified
- Feb 2022
- First submitted
- 2 Feb 2022
- Last updated
- 17 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Shape and Surface Treatment of the Transmucosal Abutments on the Bone-implant-contact and the Peri-implant Health, .
- ClinicalTrials.gov ID
- NCT05284461
- Acronym / sponsor ID
- USAL_2021_JMONT
- Conditions
- Edentulous; Alveolar Process, Atrophy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of SalamancaUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 17 Mar 2022 (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 sample was comprised by 10 patients in which 40 dental implants are placed in an atrophic maxilla. All the implants were connected to 4 types of transepithelial abutment: i.e: parallel anodized abutment(n=10); parallel mechanized abutmen(n=10)t, convergent anodized abutment(n=10); and convergent mechanized abutment (n=10) three months after insertion implants were extracted with the surrounding hard and soft tissues for the histological evaluation of the clinical performance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Mechanized parallel abutments | Placebo comparator | Device: dental implant with transepithelial abutments manufactured by Galimplant Dental System (Spain)Implants were immediately covered with this type of abutments after insertion. This is the most common procedure. It would be the gold standard |
| Anodized parallel abutments | Experimental | Device: dental implant with transepithelial abutments manufactured by Galimplant Dental System (Spain)Implants were immediately covered with this kind of abutments after insertion. Only the surface treatment varies to the gold standard |
| Mechanized convergent abutments | Experimental | Device: dental implant with transepithelial abutments manufactured by Galimplant Dental System (Spain)Implants were immediately covered with this kind of abutments after insertion. Only the geometry of the emergence profile varies with regards to the gold standard |
| Anodized convergent abutments | Experimental | Device: dental implant with transepithelial abutments manufactured by Galimplant Dental System (Spain)Implants were immediately covered with this kind of abutments after insertion. Both the surface treatment and the geometry vary with regards to the gold standard |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- totally edentulous patients in the upper arch and carriers of conventional complete dentures for more than ten years, without temporomandibular disorders
Key exclusion criteria (1 listed)
- evidence of systemic or psychic pathology that contraindicates implant treatment.
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 |
|---|---|---|
| dental implant with transepithelial abutments manufactured by Galimplant Dental System (Spain)Dental implants with transepithelial abutments with distinct morphology | Device | Anodized convergent abutments, Anodized parallel abutments, Mechanized convergent abutments, Mechanized parallel abutments |
Primary outcome
Bone to implant contact
Time frame: 3 months after healing
It is a Percentage estimation of native bone in direct contact to implant determined by histological assessments (optical microscopy)
Peri-implant inflammation of the soft tissues
Time frame: 3 months after healing
Histological assessments as ordinal variables of the grade of inflammatory infiltrate (none, minor, major)according to standard guidelines.
Density of the peri-implant soft tissues
Time frame: 3 months after healing
Histological assessments as ordinal variables of the density of the collagen fibers (low, medium, high) according to standard guidelines.
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 17 Mar 2022.
- 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 dental implant with transepithelial abutments manufactured by Galimplant Dental System (Spain) in people with Edentulous; Alveolar Process, Atrophy, run by University of Salamanca 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 1 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 17 Mar 2022. 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. Some participants in this study may receive a placebo. 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?
Bone to implant contact (time frame: 3 months after healing). The study lists 3 primary outcomes in all. 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 17 Mar 2022.