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 the influence of timing of implant placement on wound healing. In addition, there is no data available on the signaling pathways and the expression of healing biomarkers involved in the early stages of osseointegration after immediate implant placement (IP) or delayed implant placement (DP). The primary objective of this study is to describe changes in the expression of inflammatory, angiogenesis and osseous biomarkers of saliva at 1, 3, 7, 15 and 30 days and of PICF at 3, 7, 15 and 30 days after immediate implant placement (IP) compared with delayed placement (DP).
This is a two-centre prospective, parallel-group pilot study which will consist of 10 to 11 visits over a minimum period of 16 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 the Implant Research Centre, School of Dental Medicine, University of Belgrade, in accordance with local guidelines and procedures/ interventions detailed below.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
24
In this group, immediately after tooth extraction, a tapered bone level implant (Straumann BLX Implant System, Roxolid, Straumann AG, Basel, Switzerland) will be placed in an ideal prosthetically oriented position to achieve primary stability following the manufacture's guidelines. A prefabricated surgical template based on 3D pre-extraction planning will be used to place the implant. The jumping distance between the implant and the residual buccal bone will be measured and filled with slow resorption bone graft material (Bio-Oss®, Geistlich, Wolhusen, Switzerland) as per standard of practice.
A tapered bone level implant (Straumann BLX Implant System, Roxolid, Straumann AG, Basel, Switzerland) will be placed after complete bone healing (4 - 6 months after tooth extraction) in an ideal prosthetically oriented position to achieve primary stability following the manufacture's guidelines. Guided bone regeneration (GBR) will be performed simultaneously with the aim to re-establish the bone contour and treat any fenestration/dehiscence if needed. A bovine osteoconductive graft (Bio-Oss®, Geistlich, Wolhusen, Switzerland) will be loosely compacted on the buccal aspect of the implant and covered with a collagen membrane (Bio-Gide®, Geistlich, Wolhusen, Switzerland).
Centre for Oral Clinical Research
London, United Kingdom
RECRUITINGChanges 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 immediate implant placement (IP) or delayed placement (DP) and of saliva at day 1, 3, 7, 15 and 30
Time frame: 1, 3, 7, 15 and 30 days after immediate or delayed implant placement
Blood flow changes
Blood flow changes immediately after, at 1, 3, 7, 15 and 30 days after implant placement
Time frame: immediately after, 1, 3, 7, 15 and 30 days after immediate or delayed implant placement
Soft tissue volume changes
Soft tissue volume changes immediately after, at 1, 3, 7, 15, 30 days and 3 months after immediate or delayed implant placement, at loading and 6 months after implant loading
Time frame: immediately after,1, 3, 7, 15, 30 days and 3 months after immediate or delayed implant placement, 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
Implant survival
Implant functionally present in the mouth
Time frame: 6 months after implant loading
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