Abutment Macro Design and Peri-implant Tissues

Nova Southeastern University (NSU)

Status: Completed

Conditions: Edentulous

Treatments: Other: Abutment with concave subcritical contour; Other: Abutment with convex subcritical contour

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02546713

I-AA-14-075

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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 Exclusion criteria:

• Adjacent implants
• Presence of periapical radiolucency at the adjacent teeth
• Missing adjacent teeth

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

28 participants in 2 patient groups

Group 1

Other group

Description:

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

Treatment:

Other: Abutment with concave subcritical contour

Group 2

Other group

Description:

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

Treatment:

Other: Abutment with convex subcritical contour