Histological and Raman Spectroscopy Evaluation of Edentulous Alveolar Ridge Horizontal Bone Augmentations Using a Xenogeneic Bone Substitute and Autologous Platelet Concentrates: A Prospective Case Series
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Semmelweis University
- Enrollment
- 5
- Locations
- 2
- Primary Endpoint
- Amount of newly formed bone by means of histomorphometry
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •one or more missing teeth in the jaw's posterior area, where horizontal bone width is ≤5 mm.
- •no deficiency in the vertical dimension.
- •The tooth must have been removed ≥4 months before augmentation.
- •The patient should understand the nature of the research and be compliant in study-related activities
Exclusion Criteria
- •pregnancy
- •uncontrolled diabetes
- •systemic diseases or drug consumption affecting bone metabolism, and clinically relevant osteoporosis
Outcomes
Primary Outcomes
Amount of newly formed bone by means of histomorphometry
Time Frame: 5 months postoperatively
The percentage of newly formed bone of the augmented site within the biopsy
Amount of soft tissue by means of histomorphometry
Time Frame: 5 months postoperatively
The percentage of soft tissue of the augmented site within the biopsy
The quality of the newly formed tissues by means of histology
Time Frame: 5 months postoperatively
The descriptive analyses of the cells and tissue structure of the augmented site within the biopsy
Amount of graft material bone by means of histomorphometry
Time Frame: 5 months postoperatively
The percentage of graft material (THE Graft; Purgo Biologics Inc.) of the augmented site within the biopsy
Secondary Outcomes
- In vivo spectroscopy analyses of the augmented site with a Raman spectrometer device(5 months postoperatively)
- CBCT analysis(5 months postoperatively)
- The clinical descriptive bone assessment of the augmented bone site(5 months postoperatively)
Investigators
Pal Nagy
Assistant Professor
Semmelweis University