Abutment Macro Design and Peri-implant Tissues

Not Applicable

Completed

• Conditions: Edentulous
• Interventions: Other: Abutment with convex subcritical contour; Other: Abutment with concave subcritical contour

• Registration Number: NCT02546713
• Lead Sponsor: Nova Southeastern University

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.

Study Timeline

• Study First Submitted: 2015-09-09
• Study First Submitted QC: 2015-09-09
• Study First Posted: 2015-09-11
• Study Start: 2015-12
• Primary Completion: 2020-12
• Study Completion: 2021-11-30
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-12
• Last Update Posted: 2022-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

Not provided

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2	Abutment with convex subcritical contour	Abutments with convex configuration of the subcritical contour (emergence shape)
Group 1	Abutment with concave subcritical contour	Abutments with a concave configuration of the subcritical contour (emergence shape).

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Nova Southeastern University; 🇺🇸 Fort Lauderdale, Florida, United States