NCT05890469

Effect of Implant Surface Material and Topography on Bone Regeneration.

Effect of Implant Surface Material and Topography on Bone Regeneration: A Two-centre, Parallel-group, Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Queen Mary University of London · Academic / Other
• Sex: All
• Age: 25 Years
• Healthy volunteers: Not accepted

Summary

Dental implants have been on the market for several years and they are routinely used to replace single/multiple missing teeth with a high success rate. However, there is still a limited number of studies comparing hydrophilic titanium and zirconia implants. In addition, there is no data available on the signalling pathways and the expression of healing biomarkers involved in the early stages of osseointegration around zirconia surface implants placed with guided bone regeneration (GBR). This study aims 1) to describe and compare the early wound healing molecular pathways, and the 2) vascularization patterns of mucosal tissues after the placement of hydrophilic titanium or zirconia implants with simultaneous guided bone regeneration (GBR). In this study, the investigators will assess the expression of inflammatory, angiogenesis and osseous biomarkers of PICF at 3, 7, 15 and 30 days after the placement of hydrophilic titanium or zirconia dental implants with simultaneous GBR and of saliva at day 1, 3, 7, 15 and 30.

Detailed description

This is a two-centre prospective, parallel-group pilot study which will consist of 10-11 visits over a minimum period of 14 months. The study will take place at the Centre for Oral Clinical Research (COCR), at the Institute of Dentistry, Barts and The London School of Medicine and Dentistry, Queen Mary University of London (main centre), United Kingdom and at Clinic of Reconstructive Dentistry, University of Zurich, Zurich in accordance with local guidelines and procedures/interventions detailed below.

Conditions

• Dental Implant
• Guided Bone Regeneration
• Biomarkers
• Saliva

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Zirconia surface implant and guided bone regeneration	The Straumann® PURE Ceramic Implant System is made from 100 % yttria-stabilized zirconia. Its surface features a topography characterized by macro- and micro-roughness to offer a structure for cell attachment and the osseointegration of this surface has been successfully proven. Owing to the increasing aesthetic standards in the field of implant dentistry and the concerns on sensitivity to titanium, there has been a growing interest towards metal-free implant rehabilitation. Guided bone regeneration (GBR) will be performed simultaneously with the implant placement with the aim to re-establish the bone contour. A bovine osteoconductive graft (Bio-Oss collagen®, Geistlich, Wolhusen, Switzerland) will be placed on the buccal aspect of the implant and covered with a collagen membrane (Bio-Gide®, Geistlich, Wolhusen, Switzerland).
COMBINATION_PRODUCT	Hydrophilic titanium surface implant and guided bone regeneration	The Straumann® Standard Plus (SP) Implant is a Soft Tissue Level Implant with a smooth neck section of 1.8 mm. It has a fundamentally improved hydrophilic surface chemistry (SLActive®) which accelerates the osseointegration process in the early healing phase. Guided bone regeneration (GBR) will be performed simultaneously with the implant placement with the aim to re-establish the bone contour. A bovine osteoconductive graft (Bio-Oss collagen®, Geistlich, Wolhusen, Switzerland) will be placed on the buccal aspect of the implant and covered with a collagen membrane (Bio-Gide®, Geistlich, Wolhusen, Switzerland).

Timeline

• Start date: 2023-12-01
• Primary completion: 2025-01-27
• Completion: 2025-01-27
• First posted: 2023-06-06
• Last updated: 2025-04-10

Locations

2 sites across 1 country: United Kingdom