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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Ilona
Wojcik
i.wojcik@qmul.ac.uk
Miljana
Bacevic
m.bacevic@qmul.ac.uk
Prof
Nikolaos
Donos
n.donos@qmul.ac.uk
Diseases of oral cavity, salivary glands and jaws
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Although 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).
In this study we assess the differences in the expression of inflammatory, angiogenesis and osseous biomarkers of PICF and saliva at 1, 3, 7, 15 and 30 days after the placement of hydrophilic titanium or zirconia surface dental implants with simultaneous 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).
This is a two-center prospective observational study with two parallel study groups and will consist of 10-11 visits approximately around a 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, Royal London Dental Hospital - Barts Health NHS Trust (main centre), United Kingdom and at Clinic of Reconstructive Dentistry, University of Zurich, Zurich, Switzerland, in accordance with local guidelines and procedures/interventions detailed below.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Interventional type: Surgery;
You can take part if:
You may not be able to take part if:
Any known systemic disease severely affecting bone metabolism (e.g., Cushing’s syndrome, Crohn’s disease, rheumatoid arthritis, osteoporosis or diabetes type I and uncontrolled diabetes type II) Self-reported HIV or viral hepatitis Self-reported alcoholism or chronic drug abuse Smokers (including current smokers or former smokers who had quit for < 3 months); patients reporting use of vape/ e-cigarettes will also be excluded Self-reported pregnancy or lactation (this criterion is due to oral tissue changes related to pregnancy and nursing, which can affect interpretation of study results) Chronic treatment (i.e., 2 weeks or more) with any medication known to affect oral status or bone metabolism (e.g., bisphosphonates, hormone replacement therapy, immunosuppressants) within 1 month before baseline visit Chronic treatment with anticoagulants (including aspirin), corticosteroids, immunosuppressants or other medications that may influence blood coagulation/count Antibiotic or anti-inflammatory therapy during the month preceding the baseline exam. Untreated caries lesions and untreated/uncontrolled periodontal disease. If patients require periodontal treatment (non-surgical and/or surgical), this will be arranged outside the study protocol and completed prior to enrolment Inadequate keratinized tissue width (< 2 mm) in the mid-buccal aspect of the area to be treated in the study Physical handicaps that would interfere with the ability to perform adequate oral hygiene in the area of implant placement Patients requiring maxillary sinus lift surgery before implant placement Self-reported bruxism Patients not willing to receive animal-derived biomaterials for GBR Patients suffering from a known psychological disorder or with limited mental capacity or language skills such that study information could not be understood, informed consent could not be obtained, or simple instructions could not be followed Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or may interfere with the interpretation of trial results and, in the judgement of the investigator, would make the subject inappropriate for entry into this trial
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Ilona
Wojcik
i.wojcik@qmul.ac.uk
Prof
Nikolaos
Donos
n.donos@qmul.ac.uk
Miljana
Bacevic
m.bacevic@qmul.ac.uk
The study is sponsored by Queen Mary University of London and funded by Osteology Foundation (Osteology Stiftung) .
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Read full details
for Trial ID: CPMS 57029
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