Bone Loss, AlveolarNCT03524872
Implant/Abutment Module Stability of Original vs Compatible Connections
A study testing Original CAD/CAM prosthetic abutment, Compatible CAD/CAM abutment and Local anesthesia in people with Bone Loss, Alveolar and Dental Implant Failure Nos, run by University of Valencia at 1 site in Spain.
Trial summary
Together with materials and type of retention, the stability of the implant abutment connection represents one of the key factor for the success rate of an implant supported restoration. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bone Loss, Alveolar, Dental Implant Failure Nos
- What is being tested?
- Original CAD/CAM prosthetic abutment, Compatible CAD/CAM abutment and Local anesthesia
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 8 Jan 2018to Jul 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Any healthy patient scheduled for an implant-supported restoration will be considered for inclusion in this study, independently of the implant and prosthetic protocols used.
Who cannot join
- general medical contraindications to oral surgery (American Society of Anesthesiologist, ASA, class III or IV),
- patients <18 years of age,
- smoking habit (>10 cigarettes/day),
- sites with acute infection or requiring regenerative procedures,
- Full Mouth Plaque Score
- Full Mouth Bleeding Score >25 %,
- pregnant and lactating.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Clínica Odontológica de la Universitat de Valencia, Fundación Lluis Alcanyis
Valencia, 46010
David Peñarrocha Oltra, 649952560, david.penarrocha@uv.es
About this study
Official title: Implant/Abutment Module Stability: a RCT Comparing Original vs Compatible Connections (Estabilidad Del módulo Implante/Pilar: ECA Comparando Conexiones Originales vs Compatibles).
Together with materials and type of retention, the stability of the implant abutment connection represents one of the key factor for the success rate of an implant supported restoration. The recent diffusion of high quality and easy to use CAD/CAM systems has contributed to market launch of a number of competing companies that offer the so called "clonical" or "compatible" restorative components. Although they are claimed to be identical, the original abutments are supposed to present maximum accuracy and consequently lower microleakage.
The aim of the present randomized controlled trial will be to analyze the implant abutment junction stability comparing implant-supported crowns restored with original components and compatible non-original abutments.
The hypothesis is that original components will present significantly better stability than non-original abutments.
- Conditions
- Bone Loss, Alveolar, Dental Implant Failure Nos
- Being tested
- Original CAD/CAM prosthetic abutment, Compatible CAD/CAM abutment, Local anesthesia, Painkillers, Mouthwashes
- Medical subject headings
- Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Original CAD/CAM prosthetic abutmentDevice
Original (Sweden\&Martina) CAD/CAM abutments will be screwed to the implants at 32N/cm.
Compatible CAD/CAM abutmentDevice
Compatible (New Ancorvis) CAD/CAM abutments will be screwed to the implants at 32N/cm.
Local anesthesiaProcedure or surgery
Infiltration of 4% articaine with 1:100,000 adrenalin (Inibsa).
PainkillersDrug
Patients will be prescribed ibuprofen 600 mg three times per day for five days
MouthwashesDrug
Patients will be prescribed mouth-rinse with chlorhexidine 0.12% twice daily starting 3 days prior to surgery and for 2 weeks afterward
Implant placementDevice
Dental implants (Sweden \& Martina, Padua, Italy) will be placed at crestal level and according to the manufacturer's instructions.
| Study group | Role | What they receive |
|---|---|---|
| Original CAD/CAM abutment | Active comparator | Patients will be rehabilitated using Sweden\&Martina implants and original (Sweden\&Martina) CAD/CAM abutments. Receives: Device: Original CAD/CAM prosthetic abutment; Procedure: Local anesthesia; Drug: Painkillers; Drug: Mouthwashes; Device: Implant placement |
| Compatible CAD/CAM abutment | Experimental | Patients will be rehabilitated using Sweden\&Martina implants and compatible (New Ancorvis) CAD/CAM abutments. Receives: Device: Compatible CAD/CAM abutment; Procedure: Local anesthesia; Drug: Painkillers; Drug: Mouthwashes; Device: Implant placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biological complications
Proportion of cases with peri-implant disease.
Measured: 1 year
Biomechanical complications
Proportion of cases with fracture or loosening of screws
Measured: 1 year
Secondary outcomes (4)
Microbial loads
Quantitative analysis of microbial species will be studied using Illumina protocol for 6S ribosomal RNA
Measured: 1 year
Probing Pocket Depth
Measured from the mucosal margin to the bottom of the probable pocket.
Measured: 1 year
Modified Plaque Index
Presence/absence of plaque at the cervical part of the implant-supported crown scored by running a probe along the implant-supported crown surface.
Measured: 1 year
Bleeding on Probing
Presence/absence of bleeding after probing.
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 2018
- Study start8 Jan 2018
- Primary completionDec 2019 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone Loss, AlveolarStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Peñarrocha Oltra, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03524872
- Sponsor's protocol ID
- H1497611651778
- Status last verified
- Apr 2019
- First submitted
- 3 Mar 2018
- Last updated
- 30 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implant/Abutment Module Stability: a RCT Comparing Original vs Compatible Connections (Estabilidad Del módulo Implante/Pilar: ECA Comparando Conexiones Originales vs Compatibles).
- ClinicalTrials.gov ID
- NCT03524872
- Acronym / sponsor ID
- H1497611651778
- Conditions
- Bone Loss, Alveolar, Dental Implant Failure Nos
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 8 Jan 2018 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 15 May 2018 (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.
Together with materials and type of retention, the stability of the implant abutment connection represents one of the key factor for the success rate of an implant supported restoration. The recent diffusion of high quality and easy to use CAD/CAM systems has contributed to market launch of a number of competing companies that offer the so called "clonical" or "compatible" restorative components. Although they are claimed to be identical, the original abutments are supposed to present maximum accuracy and consequently lower microleakage.
The aim of the present randomized controlled trial will be to analyze the implant abutment junction stability comparing implant-supported crowns restored with original components and compatible non-original abutments.
The hypothesis is that original components will present significantly better stability than non-original abutments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Original CAD/CAM abutment | Active comparator | Device: Original CAD/CAM prosthetic abutment, Procedure: Local anesthesia, Drug: Painkillers, Drug: Mouthwashes, Device: Implant placementPatients will be rehabilitated using Sweden\&Martina implants and original (Sweden\&Martina) CAD/CAM abutments. |
| Compatible CAD/CAM abutment | Experimental | Device: Compatible CAD/CAM abutment, Procedure: Local anesthesia, Drug: Painkillers, Drug: Mouthwashes, Device: Implant placementPatients will be rehabilitated using Sweden\&Martina implants and compatible (New Ancorvis) CAD/CAM abutments. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any healthy patient scheduled for an implant-supported restoration will be considered for inclusion in this study, independently of the implant and prosthetic protocols used.
Key exclusion criteria (7 listed)
- general medical contraindications to oral surgery (American Society of Anesthesiologist, ASA, class III or IV),
- patients <18 years of age,
- smoking habit (>10 cigarettes/day),
- sites with acute infection or requiring regenerative procedures,
- Full Mouth Plaque Score
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 |
|---|---|---|
| Original CAD/CAM prosthetic abutmentOriginal (Sweden\&Martina) CAD/CAM abutments will be screwed to the implants at 32N/cm. | Device | Original CAD/CAM abutment |
| Compatible CAD/CAM abutmentCompatible (New Ancorvis) CAD/CAM abutments will be screwed to the implants at 32N/cm. | Device | Compatible CAD/CAM abutment |
| Local anesthesiaInfiltration of 4% articaine with 1:100,000 adrenalin (Inibsa). | Procedure or surgery | Compatible CAD/CAM abutment, Original CAD/CAM abutment |
| PainkillersPatients will be prescribed ibuprofen 600 mg three times per day for five days | Drug | Compatible CAD/CAM abutment, Original CAD/CAM abutment |
| MouthwashesPatients will be prescribed mouth-rinse with chlorhexidine 0.12% twice daily starting 3 days prior to surgery and for 2 weeks afterward | Drug | Compatible CAD/CAM abutment, Original CAD/CAM abutment |
| Implant placementDental implants (Sweden \& Martina, Padua, Italy) will be placed at crestal level and according to the manufacturer's instructions. | Device | Compatible CAD/CAM abutment, Original CAD/CAM abutment |
Primary outcome
Biological complications
Time frame: 1 year
Proportion of cases with peri-implant disease.
Biomechanical complications
Time frame: 1 year
Proportion of cases with fracture or loosening of screws
4 secondary outcomes
Microbial loads
Time frame: 1 year
Probing Pocket Depth
Time frame: 1 year
Modified Plaque Index
Time frame: 1 year
Bleeding on Probing
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Original CAD/CAM prosthetic abutment, Compatible CAD/CAM abutment and Local anesthesia in people with Bone Loss, Alveolar and Dental Implant Failure Nos, run by University of Valencia 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 7 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 30 Apr 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David Peñarrocha Oltra (0034649952560, david.penarrocha@uv.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biological complications (time frame: 1 year). 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 30 Apr 2019.