Abutment Macro Design and Peri-implant Tissues

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02546713

Enrollment

Registered

2015-09-11

Start date

2015-12-31

Completion date

2021-11-30

Last updated

2022-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Edentulous

Keywords

dental implants

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.

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.

Interventions

OTHERAbutment with concave subcritical contour

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

OTHERAbutment with convex subcritical contour

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Peri-implant mucosa margin position change	Day 7-10 to the Day 360	The primary outcome variable will be change on peri-implant mucosa margin position.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026