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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
12
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).
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).
Barts Health NHS Trust Dental Hospital
London, United Kingdom
Centre for Oral Clinical Research
London, United Kingdom
Changes in the expression of inflammatory, angiogenesis and osseous biomarkers of PICF and saliva
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.
Time frame: 1,3, 7, 15 and 30 days after the placement of hydrophilic titanium or zirconia dental implants.
Blood flow changes
Blood flow changes immediately after, at 1, 3, 7, 15 and 30 days after implant placement (IP)
Time frame: immediately after, 1, 3, 7, 15 and 30 days after the placement of hydrophilic titanium or zirconia dental implants
Soft tissue volume changes
Soft tissue volume changes immediately after, at 1, 3, 7, 15, 30 days and 3 months after IP, at loading and 6 months after implant loading
Time frame: immediately after,1, 3, 7, 15, 30 days and 3 months after IP, at loading and 6 months after implant loading
Peri-implant bone level
Peri-implant bone level 6 months after loading, using CBCT images
Time frame: 6 months after implant loading
Full mouth plaque score (FMPS)
FMPS will be recorded as a percentage of total surfaces (6 sites per tooth/implant), which reveal the presence of plaque. A binary score will be assigned to each surface (1 for plaque present, 0 for absent).
Time frame: 6 months after implant loading
Full mouth bleeding score (FMBS)
FMBS will be recorded as percentage of total surfaces (6 aspects per tooth/implant), which reveal the presence of bleeding within 10 - 30 seconds following periodontal probing. A binary score will be assigned to each surface (1 for bleeding present, 0 for bleeding absent).
Time frame: 6 months after implant loading
Probing pocket depth (PPD)
PPD will be measured in mm using a University of North Carolina (UNC-15) periodontal probe at six sites per tooth/implant (i.e., mesiobuccal, buccal, distobuccal, mesiolingual, lingual, and distolingual)
Time frame: 6 months after implant loading
Gingival recession (REC)
REC will be measured in mm using a University of North Carolina (UNC-15) periodontal probe at six sites per tooth/implant (i.e., mesiobuccal, buccal, distobuccal, mesiolingual, lingual, and distolingual)
Time frame: 6 months after implant loading
Clinical attachment level (CAL)
CAL will be calculated considering the values for PPD and REC in mm
Time frame: 6 months after implant loading
Suppuration
Suppuration will be recorded as percentage of total surfaces (6 aspects per tooth/implant), which reveal the presence of suppuration following periodontal probing. A binary score will be assigned to each surface (1 for suppuration present, 0 for suppuration absent)
Time frame: 6 months after implant loading
Patient satisfaction at 6 months after loading
Patient satisfaction regarding the overall implant treatment using a subjective outcome questionnaire at 6 months post loading.
Time frame: 6 months after implant loading
Changes in the pink esthetic score (PES)
Changes in the pink esthetic score (PES) from loading to 6 months after loading
Time frame: 6 months after implant loading
Changes in the white esthetic score (WES)
Changes in the white esthetic score (WES) from loading to 6 months after loading
Time frame: 6 months after implant loading
Changes in the papilla fill index (PFI)
Changes in the papilla fill index (PFI) from loading to 6 months after loading
Time frame: 6 months after implant loading
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