A Randomized Controlled Clinical Trial to Assess Crestal Bone Remodeling of Four Different Implant Designs

NCT ID: NCT06821308

Last Updated: 2025-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-18
• Study Completion Date: 2024-02-20

Brief Summary

This randomized controlled trial aimed to assess the effect of the implant neck design (microthreaded vs. non-microthreaded) as well as the type of abutment connection (internal conical vs. external flat-to-flat) on long-term crestal bone remodelling and peri-implant health. Four implants used for a bar-retained maxillary overdenture, were followed over a period of at least 6 years.

Twenty-five patients were treated with a bar-retained maxillary overdenture. Four different implants were placed, with respectively: internal connection and microthreads on the implant neck (I MT); internal connection, without microthreads (I NMT); external connection, with microthreads (E MT); and external connection, without microthreads (E NMT). Other design features, s.a. diameter, surface topography, extent of platform switch as well as the surgical and prosthetic treatment protocol were identical. Radiographic crestal bone loss (CBL), plaque score (PS), bleeding on probing (Bop) and probing pocket depth (PPD) were determined at 1 and 6 years after implant placement.

Conditions

Dental Implant Bone Loss

Study Design

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

Study Groups

Internal Microthread implant

Each participant received 4 implants, one of each type

Group Type: ACTIVE_COMPARATOR

Implant placement

Intervention Type: DEVICE

Each patient received 4 implants to support a bar supported overdenture. One implant is commercially available, 3 implants were experimentally made by the manufacturer for this study. The implants were similar in macro-desing, surface and platform shift but differ in microthread design and implant-abutment connection.

Internal Non Microthread implant

Group Type: EXPERIMENTAL

Implant placement

Intervention Type: DEVICE

Each patient received 4 implants to support a bar supported overdenture. One implant is commercially available, 3 implants were experimentally made by the manufacturer for this study. The implants were similar in macro-desing, surface and platform shift but differ in microthread design and implant-abutment connection.

External microthread implant

Group Type: EXPERIMENTAL

Implant placement

Intervention Type: DEVICE

Each patient received 4 implants to support a bar supported overdenture. One implant is commercially available, 3 implants were experimentally made by the manufacturer for this study. The implants were similar in macro-desing, surface and platform shift but differ in microthread design and implant-abutment connection.

External Non-Microthread implant

Group Type: EXPERIMENTAL

Implant placement

Intervention Type: DEVICE

Each patient received 4 implants to support a bar supported overdenture. One implant is commercially available, 3 implants were experimentally made by the manufacturer for this study. The implants were similar in macro-desing, surface and platform shift but differ in microthread design and implant-abutment connection.

Interventions

Implant placement

Each patient received 4 implants to support a bar supported overdenture. One implant is commercially available, 3 implants were experimentally made by the manufacturer for this study. The implants were similar in macro-desing, surface and platform shift but differ in microthread design and implant-abutment connection.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Edentulous in the maxilla and sufficient bone to harvest four 4 x 9 mm implant

Exclusion Criteria

• Head -and neck radiation
• Bisphosphonate intake
• Limited prosthetic height

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Ghent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hugo De Bruyn

Role: PRINCIPAL_INVESTIGATOR

University Ghent

Locations

Ghent University

Ghent, , Belgium

Countries

Belgium

References

Doornewaard R, Sakani S, Matthys C, Glibert M, Bronkhorst E, Vandeweghe S, Vervaeke S, De Bruyn H. Four-implant-supported overdenture treatment in the maxilla. Part I: A randomized controlled split mouth trial assessing the effect of microthreads and abutment connection type on 4 years peri-implant health. Clin Implant Dent Relat Res. 2021 Oct;23(5):671-679. doi: 10.1111/cid.13037. Epub 2021 Aug 11.

Reference Type: BACKGROUND

PMID: 34378860 (View on PubMed)

Glibert M, Vervaeke S, Jacquet W, Vermeersch K, Ostman PO, De Bruyn H. A randomized controlled clinical trial to assess crestal bone remodeling of four different implant designs. Clin Implant Dent Relat Res. 2018 Aug;20(4):455-462. doi: 10.1111/cid.12604. Epub 2018 Mar 25.

Reference Type: BACKGROUND

PMID: 29575488 (View on PubMed)

Matthijs S, Christiaens V, Matthys C, De Bruyn H, Glibert M. A 6-Year Randomized Controlled Trial on Different Implant Designs in Maxillary Overdenture Patients. Clin Implant Dent Relat Res. 2025 Jun;27(3):e70069. doi: 10.1111/cid.70069.

Reference Type: DERIVED

PMID: 40552788 (View on PubMed)

Other Identifiers

EC/2015/0338/AM02

Identifier Type: -

Identifier Source: org_study_id