Dental Implant-Abutment DesignNCT05051839
Validation Use of Implants and Abutments With Biologically Oriented Preparation Technique
A study testing Implant surgery and restoration in people with Dental Implant-Abutment Design, run by Universidad Complutense de Madrid at 1 site in Spain.
Trial summary
This randomized clinical trial aims to validate and to establish indications for using implants with biological oriented preparation technique (I.B.O.P.T.) for implant supported prosthetic treatment as an option looking for better stability and control of associated soft and hard tissues compared with conventional… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dental Implant-Abutment Design
- What is being tested?
- Implant surgery and restoration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 15 Jun 2017to 15 Dec 2020
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female ≥18 years old.
- Need for implant-supported fixed prosthesis in the posterior area of the upper or lower jaw (up to 2 implants and three units bridge);
- Adequate bone quality and quantity at the implant site to allow the insertion of Sweden and Martina Premium or Prama (Due Carrare, Padova, Italy), of diameters 3.8, 4.25 or 5 mm and lengths between 10 and 13 mm.
- Healthy ASA type I and II patients.
- Full-mouth plaque index <20.
Who cannot join
- Smokers ≥10 cigarettes/day.
- Presence of implant-supported restorations adjacent to the study site.
- Active periodontitis defined as the presence of pockets with probing depth (PD) ≥5 mm and bleeding on probing (BoP).
- Systemic medication that contraindicates surgery (bisphosphonates or steroid therapy).
- Uncontrolled diabetes.
- Severe bruxism.
- Pregnancy.
- Previous history of radiotherapy.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Faculty of Dentistry, Unviersidad Complutense de Madrid
Madrid, 28040
About this study
Official title: Randomized Clinical Trial to Validate Use of Implants and Abutments With Biologically Oriented Preparation Technique (I.B.O.P.T.)
This randomized clinical trial aims to validate and to establish indications for using implants with biological oriented preparation technique (I.B.O.P.T.) for implant supported prosthetic treatment as an option looking for better stability and control of associated soft and hard tissues compared with conventional implants and conventional abutments with finishing lines preparation technique.
- Conditions
- Dental Implant-Abutment Design
- Being tested
- Implant surgery and restoration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implant surgery and restorationProcedure or surgery
Implants with two different transmucosal neck configuration are placed.
| Study group | Role | What they receive |
|---|---|---|
| Radiographic bone level | Experimental | Not described Receives: Procedure: Implant surgery and restoration |
| Peri implant soft tissue volume | Experimental | Not described Receives: Procedure: Implant surgery and restoration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal bone level
Changes in interproximal marginal bone level with standardization of the radiograph
Measured: Baseline to 12-months follow-up
Soft tissue volumetric analysis
Soft tissue volumetric analysis with digital impressiones taken at baseline and at 12-month follow-up visit
Measured: Baseline to 12-motnhs follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2021
- Study start15 Jun 2017
- Primary completion15 Jun 2019
- Study completion15 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Implant-Abutment DesignStudies of the same condition, open and under way.
- More trials run by Universidad Complutense de MadridThe sponsor's other registered studies.
- 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, Care provider
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05051839
- Sponsor's protocol ID
- 14/532
- Status last verified
- Sep 2021
- First submitted
- 15 Sep 2021
- Last updated
- 21 Sep 2021
- Results posted
- 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 21 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial to Validate Use of Implants and Abutments With Biologically Oriented Preparation Technique (I.B.O.P.T.)
- ClinicalTrials.gov ID
- NCT05051839
- Acronym / sponsor ID
- 14/532
- Conditions
- Dental Implant-Abutment Design
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Study start
- 15 Jun 2017 (actual)
- Primary completion
- 15 Jun 2019 (actual)
- Study completion
- 15 Dec 2020 (actual)
- First posted
- 21 Sep 2021 (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.
This randomized clinical trial aims to validate and to establish indications for using implants with biological oriented preparation technique (I.B.O.P.T.) for implant supported prosthetic treatment as an option looking for better stability and control of associated soft and hard tissues compared with conventional implants and conventional abutments with finishing lines preparation technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiographic bone level | Experimental | Procedure: Implant surgery and restoration |
| Peri implant soft tissue volume | Experimental | Procedure: Implant surgery and restoration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female ≥18 years old.
- Need for implant-supported fixed prosthesis in the posterior area of the upper or lower jaw (up to 2 implants and three units bridge);
- Adequate bone quality and quantity at the implant site to allow the insertion of Sweden and Martina Premium or Prama (Due Carrare, Padova, Italy), of diameters 3.8, 4.25 or 5 mm and lengths between 10 and 13 mm.
- Healthy ASA type I and II patients.
- Full-mouth plaque index <20.
Key exclusion criteria (8 listed)
- Smokers ≥10 cigarettes/day.
- Presence of implant-supported restorations adjacent to the study site.
- Active periodontitis defined as the presence of pockets with probing depth (PD) ≥5 mm and bleeding on probing (BoP).
- Systemic medication that contraindicates surgery (bisphosphonates or steroid therapy).
- Uncontrolled diabetes.
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 |
|---|---|---|
| Implant surgery and restorationImplants with two different transmucosal neck configuration are placed. | Procedure or surgery | Peri implant soft tissue volume, Radiographic bone level |
Primary outcome
Marginal bone level
Time frame: Baseline to 12-months follow-up
Changes in interproximal marginal bone level with standardization of the radiograph
Soft tissue volumetric analysis
Time frame: Baseline to 12-motnhs follow-up
Soft tissue volumetric analysis with digital impressiones taken at baseline and at 12-month follow-up visit
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 21 Sep 2021.
- 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 Implant surgery and restoration in people with Dental Implant-Abutment Design, run by Universidad Complutense de Madrid 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 8 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 21 Sep 2021. 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: Baseline to 12-months follow-up). The study lists 2 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 21 Sep 2021.