VIC Klinika
Vilnius, Lithuania
NCT Number: NCT07295041
This study aimed to compare two different methods used to augment bone in the posterior lower jaw prior to implant placement in patients with insufficient bone width. Eligible patients were included in the study and received a horizontal bone augmentation with one of two methods, which differed in the materials used for the bone augmentation. The group allocation was randomised. After 6 months of healing following parameters were assessed: histological evaluation, survival of the bone graft, the need for further bone augmentation at the time of implant placement, changes in soft tissue characteristics, radiologically and clinically assessed changes in bone width.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Vilnius, Lithuania
Objective: The objective of this study is to compare the histological, clinical, and radiographic outcomes of particulate bone substitutes versus allogenic bone block grafts for primary bone augmentation in the posterior mandible.
Materials and Methods: This randomised controlled clinical trial included adult patients in need for a staged bone augmentation prior to implant placement in the posterior mandible. Patients were randomly assigned to one of two treatments groups. Patients allocated in the BBL group received allogenic bone blocks, whereas patients in the GBR group received allogenic bone granules for the primary bone augmentation. In both groups grafting materials were covered with a resorbable collagen membrane, which was fixated with non-resorbable fixation pins. The primary outcome of this study was defined as the composition of the histological samples at least 6 months after the primary bone augmentation. Secondary outcomes included graft survival rates, the need for further augementation procedures at time of implant placement, soft tissue measurements and radiographically and clinically analyzed changes in bone width and radiographically analyzed changes in bone volume. These outcomes were measured at baseline (prior to bone augmentation surgery) and at the follow-up (at least 6 months after bone augmentation).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
An allogenic bone blocks were used for the primary bone augmentation procedure.
allogenic cancellous bone granules were used for the primary bone augmentation procedure.
Time frame: 6 months
Histological samples were obtained at the time of reentry for implant placement at least 6 months after the primary bone augmentation procedure. Sample analysis included the measurement of the total sample area, the area of identified bone, biomaterial and soft tissue per sample. Furthermore, the percentage of bone, biomaterial and soft tissue per sample was calculated.
Time frame: 6 months
The need for further soft and hard tissue augmentation procedures at the time of implant placement was evaluated at the time of implant placement.
Time frame: Baseline and 6 months
keratinized tissue height measured with a periodontal probe at baseline and follow-up.
Time frame: Baseline and 6 months
the vertical soft tissue thickness measured with a periodontal probe at baseline and follow-up.
Time frame: Baseline and 6 months
the bucco-oral bone width measured with a periodontal probe at baseline and follow-up.
Time frame: Baseline and 6 months
Bucco-oral bone width in the augmented region was measured on baseline and follow-up CBCTs.
Time frame: Baseline and 6 months
CBCT images prior to bone augmentation and after the healing period were superimposed. The changes in bone volume in the augmented area were measured.
Algirdas Puisys, DDS, PhD
Network
Allogenic Bone Blocks and Particulate Graft for Horizontal Bone Augmentation in the Posterior Mandible: a Randomized Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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