Clinical trial NCT05612737: Evaluation of a Novel Horizontal Ridge Augmentation Technique in Dentistry
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bone Augmentation
Bone Loss, Alveolar
Keywords: platelet concentrate
horizontal bone augmentation
"sticky bone"
Histology
Raman spectroscopy
Lead sponsor: Semmelweis University
Sponsor class: OTHER
Collaborators: name: Purgo Biologics Inc.
name: FORM-Lab
First posted: 2022-11-10
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Amount of newly formed bone by means of histomorphometry
timeFrame: 5 months postoperatively
measure: Amount of graft material bone by means of histomorphometry
timeFrame: 5 months postoperatively
measure: Amount of soft tissue by means of histomorphometry
timeFrame: 5 months postoperatively
measure: The quality of the newly formed tissues by means of histology
timeFrame: 5 months postoperatively
Secondary outcomes:
measure: In vivo spectroscopy analyses of the augmented site with a Raman spectrometer device
timeFrame: 5 months postoperatively
measure: CBCT analysis
timeFrame: 5 months postoperatively
measure: The clinical descriptive bone assessment of the augmented bone site
timeFrame: 5 months postoperatively
measure: The clinical descriptive bone assessment of the augmented bone site
timeFrame: 5 months postoperatively
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Semmelweis University Department of Periodontology
Study officials:
References:
citation: Urban IA, Nagursky H, Lozada JL, Nagy K. Horizontal ridge augmentation with a collagen membrane and a combination of particulated autogenous bone and anorganic bovine bone-derived mineral: a prospective case series in 25 patients. Int J Periodontics Restorative Dent. 2013 May-Jun;33(3):299-307. doi: 10.11607/prd.1407.
citation: Khoury F, Hanser T. Mandibular bone block harvesting from the retromolar region: a 10-year prospective clinical study. Int J Oral Maxillofac Implants. 2015 May-Jun;30(3):688-97. doi: 10.11607/jomi.4117.
citation: Tan WL, Wong TL, Wong MC, Lang NP. A systematic review of post-extractional alveolar hard and soft tissue dimensional changes in humans. Clin Oral Implants Res. 2012 Feb;23 Suppl 5:1-21. doi: 10.1111/j.1600-0501.2011.02375.x.
citation: Farias D, Caceres F, Sanz A, Olate S. Horizontal Bone Augmentation in the Posterior Atrophic Mandible and Dental Implant Stability Using the Tenting Screw Technique. Int J Periodontics Restorative Dent. 2021 Jul-Aug;41(4):e147-e155. doi: 10.11607/prd.5137.
citation: Gheno E, Alves GG, Ghiretti R, Mello-Machado RC, Signore A, Lourenco ES, Leite PEC, Mourao CFAB, Sohn DS, Calasans-Maia MD. "Sticky Bone" Preparation Device: A Pilot Study on the Release of Cytokines and Growth Factors. Materials (Basel). 2022 Feb 16;15(4):1474. doi: 10.3390/ma15041474.
citation: Ghanaati S, Booms P, Orlowska A, Kubesch A, Lorenz J, Rutkowski J, Landes C, Sader R, Kirkpatrick C, Choukroun J. Advanced platelet-rich fibrin: a new concept for cell-based tissue engineering by means of inflammatory cells. J Oral Implantol. 2014 Dec;40(6):679-89. doi: 10.1563/aaid-joi-D-14-00138.