Evaluation of a Novel Horizontal Ridge Augmentation Technique in Dentistry

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Bone Augmentation, Bone Loss, Alveolar

Intervention / Treatment
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* Procedure: Horizontal bone augmentation


Participation Criteria
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Eligibility Criteria
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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 smoking uncontrolled diabetes systemic diseases or drug consumption affecting bone metabolism, and clinically relevant osteoporosis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: All subjects undergo the same type of horizontal bone augmentation using sticky bone (combination of xenograft and autologous platelet rich concentrate) and tenting screws.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sticky bone and tenting screw<br> | Procedure: Horizontal bone augmentation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of newly formed bone by means of histomorphometry | The percentage of newly formed bone of the augmented site within the biopsy | 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 | 5 months postoperatively | 
| Amount of soft tissue by means of histomorphometry | The percentage of soft tissue of the augmented site within the biopsy | 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 | 5 months postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 5 months postoperatively | 
| CBCT analysis | Horizontal bone volume gain (measured in mm) evaluated on pre- and postoperative CBCT-s. | 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. | 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. | 5 months postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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platelet concentrate, horizontal bone augmentation, sticky bone, Histology, Raman spectroscopy