Comparison of Implants With Different Implant Surfaces.

NCT ID: NCT07087717

Last Updated: 2025-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-12
• Study Completion Date: 2024-12-12

Brief Summary

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.

Detailed 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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

DCC-implant

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DEVICE

Surgical placement of a dental implant in canine area (left or right, assigned by flipping a coin) of the mandibular bone of the patient.

MSC-implant

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

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

Surgical placement of a dental implant in canine area (left or right, assigned by flipping a coin) of the mandibular bone of the patient.

Interventions

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

Surgical placement of a dental implant in canine area (left or right, assigned by flipping a coin) of the mandibular bone of the patient.

Intervention Type: DEVICE

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

Surgical placement of a dental implant in canine area (left or right, assigned by flipping a coin) of the mandibular bone of the patient.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Ghent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maarten Glibert, DDS, MSc, PhD

Role: PRINCIPAL_INVESTIGATOR

University Ghent

Locations

Oral Health Sciences - Department of Periodontology and Oral Implantology - P8

Ghent, , Belgium

Countries

Belgium

References

Glibert M, Matthys C, Maat RJ, De Bruyn H, Vervaeke S. A randomized controlled clinical trial assessing initial crestal bone remodeling of implants with a different surface roughness. Clin Implant Dent Relat Res. 2018 Oct;20(5):824-828. doi: 10.1111/cid.12652. Epub 2018 Jul 26.

Reference Type: BACKGROUND

PMID: 30048048 (View on PubMed)

Other Identifiers

EC/2014/1231/AM01 BC-8296

Identifier Type: -

Identifier Source: org_study_id