Study Results
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Basic Information
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COMPLETED
NA
18 participants
INTERVENTIONAL
2021-06-21
2025-02-24
Brief Summary
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Detailed Description
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An innovative and comprehensive geometric/thermal imaging analysis will be employed that is non-contact and non-invasive to patients and will allow to characterize the healing process in a 2D-3D dimensional and volumetric way.
This approach, combined with LSCI and clinical and radiographic outcomes, will provide new data on the biology and critical phases of soft tissue healing around implants, as well as on the stability and aesthetics of the peri-implant tissues with different grafts.
Patient-reported outcome measurements (PROMs) will also be used to assess the level of pain and discomfort associated with soft tissue augmentation procedures.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Conversely, outcome examiners will be blinded to treatment allocation throughout the whole study duration.
Study Groups
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No Soft tissue augmentation surgery
No soft tissue augmentation concomitant to implant placement. Negative control group.
No soft tissue augmentation
During implant placement surgery, no soft tissue augmentation will be performed
Soft tissue augmentation surgery with Fibro-Gide
Soft tissue augmentation concomitant to implant placement with a porcine, volume-stable cross-linked collagen matrix (Fibro-Gide, Geistlich Pharma AG, Wolhusen, Switzerland).
Test group.
Soft tissue augmentation surgery with Fibro-Gide
Fibro-Gide will be used to obtain buccal soft tissue augmentation. Fibro-Gide will be trimmed with a scalpel and adjusted in size and thickness to better adapt to the area buccal to the implant. In particular, the graft will be shaped in order to obtain a graft of approximately 2-3 mm of thickness and adequate length. Fibro-Gide will then be sutured to the inner side of the buccal flap, before repositioning the flap and suturing it in a tension-free way.
Soft tissue augmentation surgery with patient's CTG
Soft tissue augmentation concomitant to implant placement with a connective tissue graft (CTG) taken from the patient's palate or retromolar area.
Positive control group.
Soft tissue augmentation surgery with CTG
An epithelial-connective tissue graft of approximately 2-3 mm of thickness and adequate length will be taken from the palate or retromolar region of the patient and de-epithelialized with a scalpel (ideally a thickness of 1.5-2.0mm).
The connective tissue graft (CTG) obtained will then be positioned buccally to the dental implant and sutured to the internal side of the flap so to provide soft tissue bulk at the level of the neck of the implant and simulate a root prominence for the missing tooth.
Interventions
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Soft tissue augmentation surgery with CTG
An epithelial-connective tissue graft of approximately 2-3 mm of thickness and adequate length will be taken from the palate or retromolar region of the patient and de-epithelialized with a scalpel (ideally a thickness of 1.5-2.0mm).
The connective tissue graft (CTG) obtained will then be positioned buccally to the dental implant and sutured to the internal side of the flap so to provide soft tissue bulk at the level of the neck of the implant and simulate a root prominence for the missing tooth.
Soft tissue augmentation surgery with Fibro-Gide
Fibro-Gide will be used to obtain buccal soft tissue augmentation. Fibro-Gide will be trimmed with a scalpel and adjusted in size and thickness to better adapt to the area buccal to the implant. In particular, the graft will be shaped in order to obtain a graft of approximately 2-3 mm of thickness and adequate length. Fibro-Gide will then be sutured to the inner side of the buccal flap, before repositioning the flap and suturing it in a tension-free way.
No soft tissue augmentation
During implant placement surgery, no soft tissue augmentation will be performed
Eligibility Criteria
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Inclusion Criteria
* Good medical and psychological health.
* Absence of untreated caries lesions and untreated/uncontrolled periodontal disease. If patients require periodontal treatment (non-surgical and/or surgical), this has to be arranged outside the study protocol and completed at least 30 days prior to the enrolment.
* Need of a single-tooth replacement in the aesthetic (incisor, canine or premolar) region.
* Presence of adequate bone for implant placement without need for significant bone regeneration. In particular, the patients should have a bucco-palatal residual alveolar width of at least 6 mm at the central and crestal aspect of the single tooth gap to ensure complete embedding of an implant by bone (De Bruyckere et al., 2018).
* A residual alveolar height \>8 mm, enough inter-arch space for a crown and a minimum distance of 6 mm from the adjacent teeth.
* The width and height will be confirmed after x-ray examination in Visit 1 (or extra visit). Cases of small apical fenestration (≤ 25% of implant length) after implant placement will not be excluded, but will be treated according to the GBR principle (collagen membrane associated with a deproteinized bovine bone graft) to re-establish the bone contour and without over contouring.
* At least 8 weeks of post-extraction socket healing had occurred in the edentulous site.
* Willingness to sign the informed consent form.
Exclusion Criteria
* Any known systemic disease affecting bone metabolism (e.g. Cushing's syndrome, crohn's disease, rheumatoid arthritis, osteoporosis, diabetes type I and uncontrolled diabetes type II), systemic infections or recent surgical procedures within 30 days of study initiation.
* Chronic treatment (i.e., 2 weeks or more) with any medication known to affect oral status (e.g., phenytoin, dihydropyridine, calcium antagonists and cyclosporine) or bone metabolism (e.g. bisphosphonates, hormone replacement therapy, immunosuppressants) within 1 month before baseline visit.
* HIV or viral hepatitis.
* Physical handicaps that would interfere with the ability to perform adequate oral hygiene.
* Self-reported alcoholism or chronic drug abuse.
* Heavy smokers (\>10/cigarettes per day).
* 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 be obtained or simple instructions could be followed.
* Full-mouth bleeding (BOP) and plaque (PI) scores \>30% or sites with periodontal pocket depth \>5 mm at the completion of the pre-treatment phase.
* Very thin or very thick biotypes that according to the clinician's judgement would either risk to have complications or would not benefit from receiving a graft.
* \<2 mm KT buccally (from the mucogingival junction to the coronal aspect of the crestal soft tissue).
20 Years
80 Years
ALL
No
Sponsors
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Geistlich Pharma AG
INDUSTRY
Queen Mary University of London
OTHER
Responsible Party
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Principal Investigators
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Nikos Donos, PhD
Role: PRINCIPAL_INVESTIGATOR
Barts & The London School of Medicine & Dentistry, QMUL
Locations
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Barts and The London Dental Hospital
London, , United Kingdom
Centre for Oral Clinical Research (COCR)
London, , United Kingdom
Countries
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Other Identifiers
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IRAS 268553
Identifier Type: -
Identifier Source: org_study_id
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