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Completed

NCT Number: NCT07087717

Comparison of Implants With Different Implant Surfaces.

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.

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Key information

Conditions

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

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Ghent, 900, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

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

    Time frame: From enrollment until 8 years.

    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.

Secondary outcomes

  1. Oral Health Quality of Life (OHQoL)

    Time frame: Assessed after 1 and 8 function years.

    The patients were asked to complete an Oral Health Impact Profile-14 (OHIP-14) questionnaire. Score varies beween min.0 and max.56. Lower values indicate better conditions.

  2. Peri-implant Health: Probing pocket depth

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

    Probing pocket depth (mm) at 4 sites around the implant

  3. Peri-implant health: Bleeding on probing

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

    Bleeding on probing (yes/no) at 4 sites around the implant

  4. Peri-implant Health: Plaque

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

    Plaque (yes/no) at 4 sites around the implant

Sponsors and collaborators

Lead sponsor

University Ghent

Other

Registry information

Official study title

A Prospective Randomized Clinical Split-mouth Study on the Influence of Implant Surface Roughness on Peri-implant Bone Stability of Implants Supporting a Mandibular Overdenture.

Important dates

Study start
2015
Primary completion
2024
Study completion
2024
First posted
Jul 28, 2025
Registry last updated
Jul 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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