Comparison of Implants With Different Implant Surfaces.

University Ghent

Status: Completed

Conditions: the Effect of Surface Roughness on Crestal Bone Remodelling; The Effect of Surface Roughness on Peri-implant Health; Oral Health Quality of Life (OHQoL) Was Assessed

Treatments: Device: Split-Mouth Placement of an implant with a hybrid surface (MSC).; Device: Split-Mouth Placement of an implant with a moderately rough surface (DCC).

Study type: Interventional

Funder types: Other

Identifiers

NCT07087717

EC/2014/1231/AM01 BC-8296

Details and patient eligibility

About

This study looks at how the surface texture of dental implants affects the surrounding bone and the overall gum health over time. It compares two types of implant surfaces: one partially smooth and one slightly rough. The researchers also check how these implant treatments impact patients' quality of life related to oral health after 1 year and again after 8 years.

Full description

This split-mouth randomized controlled trial aimed to assess the effect of surface roughness on long-term crestal bone remodelling and peri-implant health, comparing hybrid and moderately rough implants. As a secondary aim, Oral Health Quality of Life (OHQoL) was assessed after 1 and 8 function years.

Enrollment: 24 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Totally edentulous for at least four months
• Sufficient residual bone volume to place two implants of 4 mm in diameter and 9-11 mm in length

Exclusion criteria

• <21 years old
• Smoking
• General contra-indications for oral surgery, e.g., full-dose head and neck radiation, intravenously administrated bisphosphonates and current chemotherapy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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24 participants in 2 patient groups

DCC-implant

Active Comparator group

Description:

Implant with a moderatley rough surface (DCC) was placed in one part of the mandible.

Treatment:

Device: Split-Mouth Placement of an implant with a moderately rough surface (DCC).

MSC-implant

Experimental group

Description:

Implant with a a hybrid surface (MSC) was placed in a second part of the mandible.

Treatment:

Device: Split-Mouth Placement of an implant with a hybrid surface (MSC).