Completed

Implant Surface Roughness Impact on Peri-implant Bone Stability for Mandibular Overdenture

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Study Aim

This study looks at how different implant surface roughness affects the long-term stability of the bone around mandibular overdentures.

What is being tested

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

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

Device
Who is being recruted

Over 21 Years
+5 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: January 2015
See protocol details

Summary

Principal SponsorUniversity Ghent
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 12, 2015

Actual date on which the first participant was enrolled.

This clinical study is designed to explore how the texture of dental implants affects the stability of the jawbone over time. It specifically compares two types of implants, one with a hybrid surface and the other with a moderately rough surface, to see which better supports a dental device called a mandibular overdenture. The focus is on patients who need these implants and are looking to improve their dental health and comfort. Understanding the impact of implant surface texture is important because it could lead to better long-term outcomes for those requiring dental prosthetics, potentially enhancing their overall oral health quality of life. Participants in the study will receive both types of implants, with one type placed on one side of the mouth and the other type on the opposite side. This approach allows researchers to directly compare the two surfaces in the same individual. Over the course of one to eight years, the researchers will monitor changes in the bone around the implants and assess the participants' oral health quality of life. This involves routine check-ups to evaluate the bone stability and the health of the surrounding tissues, ensuring a comprehensive understanding of how the implant surface affects long-term dental health.

Official TitleA Prospective Randomized Clinical Split-mouth Study on the Influence of Implant Surface Roughness on Peri-implant Bone Stability of Implants Supporting a Mandibular Overdenture.
NCT07087717
Principal SponsorUniversity Ghent
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

24 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 21 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

2 inclusion criteria required to participate
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

3 exclusion criteria prevent from participating
21 years old

Smoking

General contra-indications for oral surgery, e.g., full-dose head and neck radiation, intravenously administrated bisphosphonates and current chemotherapy.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Group II

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

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

Ghent, BelgiumOpen Oral Health Sciences - Department of Periodontology and Oral Implantology - P8 in Google Maps
CompletedOne Study Center