Comparison of Implants With Different Implant Surfaces.

Not Applicable

Completed

• 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

• Registration Number: NCT07087717
• Lead Sponsor: University Ghent

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.

Detailed Description

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.

Study Timeline

• Study Start: 2015-01-12
• Primary Completion: 2024-12-12
• Study Completion: 2024-12-12
• Study First Submitted: 2025-06-26
• Status Verified: 2025-07
• Study First Submitted QC: 2025-07-18
• Last Update Submitted: 2025-07-18
• Study First Posted: 2025-07-28
• Last Update Posted: 2025-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The effect of surface roughness on long-term crestal bone remodelling.	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 Outcome Measures

Name	Time	Method
Oral Health Quality of Life (OHQoL)	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.
Peri-implant Health: Probing pocket depth	At one year, 6 years, 8 years and 10 years of follow-up	Probing pocket depth (mm) at 4 sites around the implant
Peri-implant health: Bleeding on probing	At one year, 6 years, 8 years and 10 years of follow-up.	Bleeding on probing (yes/no) at 4 sites around the implant
Peri-implant Health: Plaque	at one year, 6 years, 8 years and 10 years of follow-up.	Plaque (yes/no) at 4 sites around the implant

Trial Locations

Locations (1)

Oral Health Sciences - Department of Periodontology and Oral Implantology - P8; 🇧🇪 Gent, Belgium