Clinical trial NCT06821308: A Randomized Controlled Clinical Trial to Assess Crestal Bone Remodeling of Four Different Implant Designs
Official title: A Randomized Controlled Clinical Trial to Assess Crestal Bone Remodeling of Four Different Implant Designs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Implant Bone Loss
Keywords: Dental implant, crestal bone loss, microthreads, implant-abutment connection
Lead sponsor: University Ghent
Sponsor class: OTHER
First posted: 2025-02-11
Enrollment: 25
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Split-mouth study
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Crestal bone loss
timeFrame: The measurements were performed at 1 and 6 years
Secondary outcomes:
measure: Plaque
timeFrame: The measurements were performed at 1 and 6 years
measure: Probing pocket depth
timeFrame: The measurements were performed at 1 and 6 years
measure: Bleeding on probing
timeFrame: The measurements were performed at 1 and 6 years
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University
Study officials:
affiliation: University Ghent
name: Hugo De Bruyn
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.