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Completed

NCT Number: NCT02546713

Abutment Macro Design and Peri-implant Tissues

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.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nova Southeastern University

Fort Lauderdale, Florida, 33328, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Abutment with concave subcritical contour

Other

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

Abutment with convex subcritical contour

Other

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

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Nova Southeastern University

Other

Collaborators

  • Dentsply Sirona Implants and Consumables

Registry information

Official study title

The Influence of Abutment Macro-design on Peri-implant Tissue Dimensions for Guided Placed and Restored Implants

Important dates

Study start
2015
Primary completion
2020
Study completion
2021
First posted
Sep 11, 2015
Registry last updated
Apr 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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