An interventional study of Horizontal bone augmentation in Bone Augmentation and Bone Loss, Alveolar, sponsored by Semmelweis University. Completed at 1 site in Hungary. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-10.
Sponsored by Semmelweis University · Not applicable, Interventional, and Treatment
This case series aimed to assess the efficacy of a novel horizontal ridge augmentation modality using histomorphometry and Raman spectroscopy. Combinations of "sticky bone" and tenting screws without autologous bone were used as augmentative materials.
This case series aimed to evaluate the efficacy of the horizontal augmentation technique using the tenting screw technique with "sticky bone." The main aim was to determine whether this method provides similar results to the gold standard GBR or autologous onlay block grafts. In addition, the validity of neglecting autologous graft and its possible substitution with growth factor concentrate were examined. The novelty of this study is that no human histological examination of the described procedure has been conducted previously. It is hypothesized that the "stick bone" containing autologous platelet concentrate can substitute the use of particulate autologous bone graft in these type of procedures. In this prospective case series study five patients were enrolled and treated with the same type of bone augmentation in order to increase the alveolar ridge in the horizontal dimension with the previously mentioned technique. After 5 months of healing a second reentry surgery was performed in order to harvest the bone core for biopsy, to asses the chemical compound composition by Raman spectroscopy in vivo and to place the dental implants at the same time. Newly formed tissues were evaluated clinically during reentry, radiologically by CBCT acquisition, qualitatively and quantitatively by histological processing and physicochemically by means of Raman spectroscopy.
297 studies on the registry are indexed under Alveolar Bone Loss; 76 are open to participants now.
This study's enrollment of 5 is below the median of 25 across 254 interventional studies indexed under Alveolar Bone Loss.
Browse Alveolar Bone Loss studies →Semmelweis University is the lead sponsor of 136 studies on the registry; 54 are open to participants now.
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Procedure: Horizontal bone augmentation
After taking six 9 mL tubes of blood from the patient, advanced (A-PRF) and liquid (S-PRF) PRFs were prepared. A-PRF was chopped, added to the xenogeneic bone substitute (THE Graft; Purgo Biologics Inc.), and then impregnated with the liquid S-PRF, which enabled the particulate bone substitute to become moldable and turned into a block ("sticky bone"). After local anesthesia, a midcrestal incision was made with one vertical releasing incision at the flap's mesial end. After full-thickness flap elevation, a periosteal releasing incision was made at the flap's apical portion. The alveolar bone was decorticalized on the buccal aspect with surgical burs. Next, the prepared "bonded" graft matrix was adapted to the ridge. Then, tenting screws (Pro-fix; Osteogenics) were placed to maintain the periosteum in an elevated and tension-free position The bone augmentation material was covered with A-PRF membranes. Finally, tension-free wound closure was performed.
Amount of newly formed bone by means of histomorphometry
The percentage of newly formed bone of the augmented site within the biopsy
Time frame: 5 months postoperatively
Amount of graft material bone by means of histomorphometry
The percentage of graft material (THE Graft; Purgo Biologics Inc.) of the augmented site within the biopsy
Time frame: 5 months postoperatively
Amount of soft tissue by means of histomorphometry
The percentage of soft tissue of the augmented site within the biopsy
Time frame: 5 months postoperatively
The quality of the newly formed tissues by means of histology
The descriptive analyses of the cells and tissue structure of the augmented site within the biopsy
Time frame: 5 months postoperatively
In vivo spectroscopy analyses of the augmented site with a Raman spectrometer device
Raman investigation (measuring wavelength in the range 300-1800 cm-1) highlights the peaks (Raman shift) for the main bone components (chemical groups and elements) in order to evaluate differences between bone tissue for the investigated patients. Differences in peaks intensity on raw spectra reflected the differences in the quantities of the chemical components for investigated specimens.
Time frame: 5 months postoperatively
CBCT analysis
Horizontal bone volume gain (measured in mm) evaluated on pre- and postoperative CBCT-s.
Time frame: 5 months postoperatively
The clinical descriptive bone assessment of the augmented bone site
The descriptive clinical assessment is a subjective evaluation of the augmented bone judged by the operator. The presence of possibly occuring non-integrated graft remnants can be assessed during reentry surgery.
Time frame: 5 months postoperatively
The clinical descriptive bone assessment of the augmented bone site
The descriptive clinical assessment is a subjective evaluation of the augmented bone judged by the operator. The bleeding property of the newly formed bone after drilling the osteotomy for the implant can be assessed during reentry.
Time frame: 5 months postoperatively
Plan to share: No
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Semmelweis University