Abutment Macro Design and Peri-implant Tissues

April 12, 2022 updated by: Theofilos Koutouzis, Nova Southeastern University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Fort Lauderdale, Florida, United States, 33328
        • Nova Southeastern University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Group 1
Abutments with a concave configuration of the subcritical contour (emergence shape).
Other: Abutment with concave subcritical contour
Implants will be restored with abutments with concave configuration of the subcritical contour
Other: Group 2
Abutments with convex configuration of the subcritical contour (emergence shape)
Other: Abutment with convex subcritical contour
Implants will be restored with abutments with convex configuration of the subcritical contour

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 7-10 to the Day 360

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nova Southeastern University

Collaborators

Dentsply Sirona Implants and Consumables

Investigators

  • Principal Investigator: Theofilos Koutouzis, DDS, Nova Southeastern University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2015

Primary Completion (Actual)

December 1, 2020

Study Completion (Actual)

November 30, 2021

Study Registration Dates

First Submitted

September 9, 2015

First Submitted That Met QC Criteria

September 9, 2015

First Posted (Estimate)

September 11, 2015

Study Record Updates

Last Update Posted (Actual)

April 13, 2022

Last Update Submitted That Met QC Criteria

April 12, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • I-AA-14-075

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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