Abutment Macro Design and Peri-implant Tissues

NCT ID: NCT02546713

Last Updated: 2022-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2021-11-30

Brief Summary

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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

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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

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Edentulous

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Group 1

Abutments with a concave configuration of the subcritical contour (emergence shape).

Group Type OTHER

Abutment with concave subcritical contour

Intervention Type OTHER

Implants will be restored with abutments with concave configuration of the subcritical contour

Group 2

Abutments with convex configuration of the subcritical contour (emergence shape)

Group Type OTHER

Abutment with convex subcritical contour

Intervention Type OTHER

Implants will be restored with abutments with convex configuration of the subcritical contour

Interventions

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Abutment with concave subcritical contour

Implants will be restored with abutments with concave configuration of the subcritical contour

Intervention Type OTHER

Abutment with convex subcritical contour

Implants will be restored with abutments with convex configuration of the subcritical contour

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* \- Age more than 21 years
* Absence of relevant medical conditions
* Availability for 12 month follow-up


* 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

Exclusion Criteria

* \- Pregnancy at the screening visit.
* Smoking more than 10 cig/day


* Adjacent implants
* Presence of periapical radiolucency at the adjacent teeth
* Missing adjacent teeth
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dentsply Sirona Implants and Consumables

INDUSTRY

Sponsor Role collaborator

Nova Southeastern University

OTHER

Sponsor Role lead

Responsible Party

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Theofilos Koutouzis

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Theofilos Koutouzis, DDS

Role: PRINCIPAL_INVESTIGATOR

Nova Southeastern University

Locations

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Nova Southeastern University

Fort Lauderdale, Florida, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 25216143 (View on PubMed)

Koutouzis 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.

Reference Type BACKGROUND
PMID: 21542730 (View on PubMed)

Other Identifiers

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I-AA-14-075

Identifier Type: -

Identifier Source: org_study_id

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