PeriimplantitisPhase 4NCT01954485
Adhesion of Connective Tissue Around Laser-treated Abutments for Dental Implants - Clinical Trial in Humans
A Phase 4 study testing Dental implant placement with a final prosthetic abutment in people with Periimplantitis, run by University of Barcelona at 1 site in Spain.
Trial summary
This study aims to demonstrate the histological differences in the connective tissue surrounding laser-treated abutments and untreated abutments in humans. Working hypothesis: There are differences in the adhesion of collagen fibres around implant abutments with laser-produced microgrooves and standard abutments. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Periimplantitis
- What is being tested?
- Dental implant placement with a final prosthetic abutment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteSpain
- Study dates
- Jan 2013to Sep 2014
- Phase
- Phase 4
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patient must have partial edentulism of at least 2 teeth
- patients that have scheduled treatment for the placement of at least 2 implants
- patients with favourable attached gingiva
- patients without systemic diseases that would prevent the emplacement of implants
- patient must accept participation in the study by signing an informed consent form
Who cannot join
- smokers of 1 or more cigarettes per day
- patients who suffer from any known condition that could be an absolute or relative contraindication to dental implant placement
- patients requiring any additional surgical technique for bone or gum graft in order to insert the dental implant
- patients who refuse to be included in the study or do not sign the informed consent form
Trial locations and contacts
1 site in 1 country.
Raul Ayuso-Montero contact
Spain1 site, 1 recruiting
- Recruiting
Hospital Odontològic
L'Hospitalet de Llobregat, Barcelona, 89070
Raul Ayuso-Montero, Associate Professor, raulayuso@ub.edu
Monica Blazquez-Hinarejos, DDS
About this study
Official title: Histological Differences in the Adhesion of Connective Tissue Around Laser-treated Abutments and Standard Abutments for Dental Implants - Clinical Trial in Humans
This study aims to demonstrate the histological differences in the connective tissue surrounding laser-treated abutments and untreated abutments in humans.
Working hypothesis: There are differences in the adhesion of collagen fibres around implant abutments with laser-produced microgrooves and standard abutments.
Read the detailed description
All patients will receive both abutment systems. The assignment of the abutments to each of the implants will be made randomly using SPSS 15.0 (SPSS Inc., Chicago, Il, United States) software.
- Conditions
- Periimplantitis
- Being tested
- Dental implant placement with a final prosthetic abutment
- Keywords
- LaserLok, connective tissue, adhesion
- Medical subject headings
- Peri-Implantitis, Tissue Adhesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental implant placement with a final prosthetic abutmentProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| LaserLok abutment | Experimental | Laser microtexturing dental implant abutment Receives: Procedure: Dental implant placement with a final prosthetic abutment |
| 3inOne abutment | Active comparator | Standard dental implant abutment Receives: Procedure: Dental implant placement with a final prosthetic abutment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Connective tissue adhesion
At 90 days after the first operation, a second surgical procedure will be scheduled. A cilindrical scalpel of a diameter 2 mm greater than the abutment is used to make the incision and the abutment unscrewed together with the gingival insertion surrounding it for histological study.
The attachment of connective tissue to the abutments will be determined by microscopic observation. It will be a binary variable: attachment IS present (YES-A); attachment IS NOT present (NO-A).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2013 (estimated)
- Study startJan 2013
- Primary completionSep 2013
- Study completionSep 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriimplantitisStudies 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 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
Sponsor and investigators
- Lead sponsor
- University of Barcelona
- Sponsor type
- University, hospital or other
- Collaborators
- BioHorizons, Inc.
- Responsible party
- Principal investigator, Raul Ayuso Montero, D.D.S., University of Barcelona
- Investigators
- Monica Blazquez-Hinarejos, DDS, Principal investigator, Barcelona UniversityRaul Ayuso-Montero, DDS, PhD, Study director, Barcelona UniversityJose Lopez-Lopez, MD, PhD, Study chair, Barcelona UniversityCristina Manzanares-Cespedes, MD, PhD, Study director, Barcelona University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01954485
- Sponsor's protocol ID
- Laser-Lok® abutment
- Status last verified
- Sep 2013
- First submitted
- 19 Sep 2013
- Last updated
- 1 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Histological Differences in the Adhesion of Connective Tissue Around Laser-treated Abutments and Standard Abutments for Dental Implants - Clinical Trial in Humans
- ClinicalTrials.gov ID
- NCT01954485
- Acronym / sponsor ID
- Laser-Lok® abutment
- Conditions
- Periimplantitis
- Keywords
- LaserLok, connective tissue, adhesion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- University of BarcelonaUniversity, hospital or other
- Collaborators
- BioHorizons, Inc.
- Study start
- Jan 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2014 (estimated)
- First posted
- 1 Oct 2013 (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.
This study aims to demonstrate the histological differences in the connective tissue surrounding laser-treated abutments and untreated abutments in humans.
Working hypothesis: There are differences in the adhesion of collagen fibres around implant abutments with laser-produced microgrooves and standard abutments.
Detailed description
All patients will receive both abutment systems. The assignment of the abutments to each of the implants will be made randomly using SPSS 15.0 (SPSS Inc., Chicago, Il, United States) software.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LaserLok abutment | Experimental | Procedure: Dental implant placement with a final prosthetic abutmentLaser microtexturing dental implant abutment |
| 3inOne abutment | Active comparator | Procedure: Dental implant placement with a final prosthetic abutmentStandard dental implant abutment |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- patient must have partial edentulism of at least 2 teeth
- patients that have scheduled treatment for the placement of at least 2 implants
- patients with favourable attached gingiva
- patients without systemic diseases that would prevent the emplacement of implants
- patient must accept participation in the study by signing an informed consent form
Key exclusion criteria (4 listed)
- smokers of 1 or more cigarettes per day
- patients who suffer from any known condition that could be an absolute or relative contraindication to dental implant placement
- patients requiring any additional surgical technique for bone or gum graft in order to insert the dental implant
- patients who refuse to be included in the study or do not sign the informed consent form
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 placement with a final prosthetic abutment | Procedure or surgery | 3inOne abutment, LaserLok abutment |
Primary outcome
Connective tissue adhesion
Time frame: 3 months
At 90 days after the first operation, a second surgical procedure will be scheduled. A cilindrical scalpel of a diameter 2 mm greater than the abutment is used to make the incision and the abutment unscrewed together with the gingival insertion surrounding it for histological study. The attachment of connective tissue to the abutments will be determined by microscopic observation. It will be a binary variable: attachment IS present (YES-A); attachment IS NOT present (NO-A).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2013.
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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.
Raul Ayuso-Montero contact
Monica Blazquez-Hinarejos, DDS principal investigator
Barcelona University
Raul Ayuso-Montero, DDS, PhD study director
Barcelona University
Jose Lopez-Lopez, MD, PhD study chair
Barcelona University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dental implant placement with a final prosthetic abutment in people with Periimplantitis, run by University of Barcelona 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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 1 Oct 2013. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Raul Ayuso-Montero (raulayuso@ub.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Connective tissue adhesion (time frame: 3 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 1 Oct 2013.