Phase
Condition
Dental Filling
Treatment
Hydrophilic titanium surface implant and guided bone regeneration
Zirconia surface implant and guided bone regeneration
Clinical Study ID
Ages > 25 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Males and females, ≥ 25 years old
Good/controlled medical and psychological health
Good oral hygiene (full mouth plaque scores [FMPS< 30%])
Need of a single-tooth replacement in the aesthetic (incisor, canine or premolar)region
At least one neighbouring natural tooth present
A functional occlusion with a minimum of four occlusal units (i.e., pairs ofoccluding posterior teeth)
At least 3 months of post-extraction socket healing had occurred in the edentuloussite and no ridge preservation was performed
After implant placement, presence of buccal bone dehiscence/fenestration or thinbuccal bone plate (<2mm) requiring guided bone regeneration (GBR) (including contouraugmentation) [to be confirmed after implant placement]
Willingness to read and sign a copy of the Informed Consent Form (ICF) after readingthe Patient Information Sheet (PIS), and after the nature of the study has beenfully explained and potential questions fully answered
Exclusion
Exclusion Criteria:
Any known systemic disease severely affecting bone metabolism (e.g., Cushing'ssyndrome, Crohn's disease, rheumatoid arthritis, osteoporosis or diabetes type I anduncontrolled 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 changesrelated 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 oralstatus 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 baselineexam.
Untreated caries lesions and untreated/uncontrolled periodontal disease. If patientsrequire periodontal treatment (non-surgical and/or surgical), this will be arrangedoutside the study protocol and completed prior to enrolment
Inadequate keratinized tissue width (<2 mm) in the mid-buccal aspect of the area tobe treated in the study
Physical handicaps that would interfere with the ability to perform adequate oralhygiene 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 mentalcapacity 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 laboratoryabnormality that may increase the risk associated with trial participation or mayinterfere with the interpretation of trial results and, in the judgement of theinvestigator, would make the subject inappropriate for entry into this trial
Study Design
Study Description
Connect with a study center
Barts Health NHS Trust Dental Hospital
London, E1 1BB
United KingdomSite Not Available
Centre for Oral Clinical Research
London, E1 2AD
United KingdomSite Not Available
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