Comparison of Implants With Different Implant Surfaces.

NCT07087717 | Completed

• 1 other identifier: EC/2014/1231/AM01 BC-8296
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

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

Keywords

implant surface; implant-supported overdenture; oral health quality of life; implant survival; hybrid implants; moderately rough implants

Outcome Measures

Primary Outcomes (1)

• The effect of surface roughness on long-term crestal bone remodelling.

  The effect of surface roughness on long-term crestal bone remodelling is evaluated by recording crestal bone loss (mm) on intra-oral periapical radiographs of the implants.

  From enrollment until 8 years.

Secondary Outcomes (4)

• Oral Health Quality of Life (OHQoL)

  Assessed after 1 and 8 function years.

• Peri-implant Health: Probing pocket depth

  At one year, 6 years, 8 years and 10 years of follow-up

• Peri-implant health: Bleeding on probing

  At one year, 6 years, 8 years and 10 years of follow-up.

• Peri-implant Health: Plaque

  at one year, 6 years, 8 years and 10 years of follow-up.

Study Arms (2)

DCC-implant

ACTIVE COMPARATOR

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

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

MSC-implant

EXPERIMENTAL

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

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

Interventions

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

DCC-implant

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

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Ghent: lead

Study Sites (1)

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

Ghent, 900, Belgium

Location

Related Publications (1)

• 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.

  PMID: 30048048 BACKGROUND

Study Officials

• Maarten Glibert, DDS, MSc, PhD

  University Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: In this split-mouth randomized controlled trial patients received a mandibular overdenture supported by 2 different implants. One implant had a moderately rough surface (DCC) and one implant had a hybrid surface (MSC).

Study Record Dates

• First Submitted: June 26, 2025
• First Posted: July 28, 2025
• Study Start: January 12, 2015
• Primary Completion: December 12, 2024
• Study Completion: December 12, 2024
• Last Updated: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)