NCT02546713

Brief 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 region.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 9, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 11, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2021

Completed
Last Updated

April 13, 2022

Status Verified

April 1, 2022

Enrollment Period

5 years

First QC Date

September 9, 2015

Last Update Submit

April 12, 2022

Conditions

Edentulous

Keywords

dental implants

Outcome Measures

Primary Outcomes (1)

  • Peri-implant mucosa margin position change

    The primary outcome variable will be change on peri-implant mucosa margin position.

    Day 7-10 to the Day 360

Study Arms (2)

Group 1

OTHER

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

Other: Abutment with concave subcritical contour

Group 2

OTHER

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

Other: Abutment with convex subcritical contour

Interventions

Abutment with concave subcritical contourOTHER

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

Group 1
Abutment with convex subcritical contourOTHER

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

Group 2

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- 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

You may not qualify if:

  • \- Pregnancy at the screening visit.
  • Smoking more than 10 cig/day
  • Adjacent implants
  • Presence of periapical radiolucency at the adjacent teeth
  • Missing adjacent teeth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nova Southeastern University

Fort Lauderdale, Florida, 33328, United States

Location

Related Publications (2)

  • 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.

    PMID: 25216143BACKGROUND

  • 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.

    PMID: 21542730BACKGROUND

MeSH Terms

Conditions

Mouth, Edentulous

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesTooth Diseases

Study Officials

  • Theofilos Koutouzis, DDS

    Nova Southeastern University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 9, 2015

First Posted

September 11, 2015

Study Start

December 1, 2015

Primary Completion

December 1, 2020

Study Completion

November 30, 2021

Last Updated

April 13, 2022

Record last verified: 2022-04

Locations

US(1)