EdentulousNCT02546713
Abutment Macro Design and Peri-implant Tissues
A study testing Abutment with concave subcritical contour and Abutment with convex subcritical contour in people with Edentulous, run by Nova Southeastern University at 1 site in United States.
Trial summary
The aim of this study is to evaluate the effect of abutment macro-design on soft and hard tissue responses. This trial is designed as a randomized controlled clinical study in which two groups of fourteen partially edentulous patients will have as part of their treatment one implant placed in the maxillary premolar… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Edentulous
- What is being tested?
- Abutment with concave subcritical contour and Abutment with convex subcritical contour
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to 30 Nov 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
General Inclusion criteria:
- - Age more than 21 years
- Absence of relevant medical conditions
- Availability for 12 month follow-up
Specific Inclusion criteria:
- One missing tooth in the maxillary premolar region
- Presence of two adjacent teeth at the implant site
- Absence of periodontal disease
- Healed osseous architecture enough to receive an implant with a diameter of at least 3.5 mm and a sufficient amount of bone for placing implants with a length of at least 9 mm
General Exclusion Criteria:
- - Pregnancy at the screening visit.
- Smoking more than 10 cig/day
Specific Exclusion criteria:
- Adjacent implants
- Presence of periapical radiolucency at the adjacent teeth
- Missing adjacent teeth
Trial locations and contacts
1 site in 1 country.
United States1 site
Nova Southeastern University
Fort Lauderdale, Florida, 33328
About this study
Official title: The Influence of Abutment Macro-design on Peri-implant Tissue Dimensions for Guided Placed and Restored Implants
The aim of this study is to evaluate the effect of abutment macro-design on soft and hard tissue responses. This trial is designed as a randomized controlled clinical study in which two groups of fourteen partially edentulous patients will have as part of their treatment one implant placed in the maxillary premolar region.
Read the detailed description
Implant placement and abutment design will be planned with a computer software for guided implant treatment (SIMPLANT). The surgical implant placement will be performed under manufacturer's protocol by placing the implant platform 1mm below the buccal aspect of the osteotomy (Koutouzis et al 2013). Virtually designed, permanent CAD-CAM fabricated abutments (ATLANTIS, DENTSPLY) with different configuration of the subcritical contour (emergence shape) will be connected to the implants and temporary crowns will be delivered.
Implants of the Group 1 will have permanent abutments with a concave configuration of the subcritical contour (emergence shape).
Implants of the Group 2 will have permanent abutments with a convex configuration of the subcritical contour (emergence shape).
The patients will be restored with single crowns 3 months following implant installation.
A randomization protocol will be produced from a computer-generated list for the distribution of subjects in the two treatment groups.
- Conditions
- Edentulous
- Being tested
- Abutment with concave subcritical contour, Abutment with convex subcritical contour
- Keywords
- dental implants
- Medical subject headings
- Mouth, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abutment with concave subcritical contourOther
Implants will be restored with abutments with concave configuration of the subcritical contour
Abutment with convex subcritical contourOther
Implants will be restored with abutments with convex configuration of the subcritical contour
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Other | Abutments with a concave configuration of the subcritical contour (emergence shape). Receives: Other: Abutment with concave subcritical contour |
| Group 2 | Other | Abutments with convex configuration of the subcritical contour (emergence shape) Receives: Other: Abutment with convex subcritical contour |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peri-implant mucosa margin position change
The primary outcome variable will be change on peri-implant mucosa margin position.
Measured: Day 7-10 to the Day 360
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2015 (estimated)
- Study startDec 2015
- Primary completionDec 2020
- Study completion30 Nov 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 EdentulousStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Southeastern University
- Sponsor type
- University, hospital or other
- Collaborators
- Dentsply Sirona Implants and Consumables
- Responsible party
- Principal investigator, Theofilos Koutouzis, Nova Southeastern University
- Investigators
- Theofilos Koutouzis, DDS, Principal investigator, Nova Southeastern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02546713
- Sponsor's protocol ID
- I-AA-14-075
- Status last verified
- Apr 2022
- First submitted
- 9 Sep 2015
- Last updated
- 13 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Koutouzis T, Neiva R, Nair M, Nonhoff J, Lundgren T. Cone beam computed tomographic evaluation of implants with platform-switched Morse taper connection with the implant-abutment interface at different levels in relation to the alveolar crest. Int J Oral Maxillofac Implants. 2014 Sep-Oct;29(5):1157-63. doi: 10.11607/jomi.3411.
PubMed 25216143Koutouzis T, Koutouzis G, Tomasi C, Lundgren T. Immediate loading of implants placed with the osteotome technique: one-year prospective case series. J Periodontol. 2011 Nov;82(11):1556-62. doi: 10.1902/jop.2011.100751. Epub 2011 May 4.
PubMed 21542730
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Abutment Macro-design on Peri-implant Tissue Dimensions for Guided Placed and Restored Implants
- ClinicalTrials.gov ID
- NCT02546713
- Acronym / sponsor ID
- I-AA-14-075
- Conditions
- Edentulous
- Keywords
- dental implants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Nova Southeastern UniversityUniversity, hospital or other
- Collaborators
- Dentsply Sirona Implants and Consumables
- Study start
- Dec 2015 (actual)
- Primary completion
- Dec 2020 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 11 Sep 2015 (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 aim of this study is to evaluate the effect of abutment macro-design on soft and hard tissue responses. This trial is designed as a randomized controlled clinical study in which two groups of fourteen partially edentulous patients will have as part of their treatment one implant placed in the maxillary premolar region.
Detailed description
Implant placement and abutment design will be planned with a computer software for guided implant treatment (SIMPLANT). The surgical implant placement will be performed under manufacturer's protocol by placing the implant platform 1mm below the buccal aspect of the osteotomy (Koutouzis et al 2013). Virtually designed, permanent CAD-CAM fabricated abutments (ATLANTIS, DENTSPLY) with different configuration of the subcritical contour (emergence shape) will be connected to the implants and temporary crowns will be delivered.
Implants of the Group 1 will have permanent abutments with a concave configuration of the subcritical contour (emergence shape).
Implants of the Group 2 will have permanent abutments with a convex configuration of the subcritical contour (emergence shape).
The patients will be restored with single crowns 3 months following implant installation.
A randomization protocol will be produced from a computer-generated list for the distribution of subjects in the two treatment groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Other | Other: Abutment with concave subcritical contourAbutments with a concave configuration of the subcritical contour (emergence shape). |
| Group 2 | Other | Other: Abutment with convex subcritical contourAbutments with convex configuration of the subcritical contour (emergence shape) |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Abutment with concave subcritical contourImplants will be restored with abutments with concave configuration of the subcritical contour | Other | Group 1 |
| Abutment with convex subcritical contourImplants will be restored with abutments with convex configuration of the subcritical contour | Other | Group 2 |
Primary outcome
Peri-implant mucosa margin position change
Time frame: Day 7-10 to the Day 360
The primary outcome variable will be change on peri-implant mucosa margin position.
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 13 Apr 2022.
- Background: PubMed 25216143Koutouzis T, Neiva R, Nair M, Nonhoff J, Lundgren T. Cone beam computed tomographic evaluation of implants with platform-switched Morse taper connection with the implant-abutment interface at different levels in relation to the alveolar crest. Int J Oral Maxillofac Implants. 2014 Sep-Oct;29(5):1157-63. doi: 10.11607/jomi.3411.
- Background: PubMed 21542730Koutouzis T, Koutouzis G, Tomasi C, Lundgren T. Immediate loading of implants placed with the osteotome technique: one-year prospective case series. J Periodontol. 2011 Nov;82(11):1556-62. doi: 10.1902/jop.2011.100751. Epub 2011 May 4.
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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.
Theofilos Koutouzis, DDS principal investigator
Nova Southeastern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abutment with concave subcritical contour and Abutment with convex subcritical contour in people with Edentulous, run by Nova Southeastern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 13 Apr 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 United States. 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?
Peri-implant mucosa margin position change (time frame: Day 7-10 to the Day 360). 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 NCT02546713, 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 13 Apr 2022; AzTrials last refreshed its copy on 31 Oct 2026.