Abutment Macro Design and Peri-implant Tissues

Edentulous Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02546713
• Other study ID #: I-AA-14-075
• Status: Completed
• Phase: N/A
• Start date: December 2015
• Est. completion date: November 30, 2021

Study information

• Verified date: April 2022
• Source: Nova Southeastern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: November 30, 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Edentulous
• Mouth, Edentulous

Intervention

Other:
• Abutment with concave subcritical contour
Implants will be restored with abutments with concave configuration of the subcritical contour
• Abutment with convex subcritical contour
Implants will be restored with abutments with convex configuration of the subcritical contour

Locations

Country	Name	City	State
United States	Nova Southeastern University	Fort Lauderdale	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Nova Southeastern University	Dentsply Sirona Implants

Country where clinical trial is conducted

United States, 

References & Publications (2)

Koutouzis T, Koutouzis G, Tomasi C, Lundgren T. Immediate loading of implants placed with the osteotome technique: one-year prospective case series. J Periodontol. 2011 Nov;82(11):1556-62. doi: 10.1902/jop.2011.100751. Epub 2011 May 4. — View Citation

Koutouzis T, Neiva R, Nair M, Nonhoff J, Lundgren T. Cone beam computed tomographic evaluation of implants with platform-switched Morse taper connection with the implant-abutment interface at different levels in relation to the alveolar crest. Int J Oral Maxillofac Implants. 2014 Sep-Oct;29(5):1157-63. doi: 10.11607/jomi.3411. — View Citation

Outcome

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