Evaluation of a Novel Horizontal Ridge Augmentation Technique in Dentistry

Bone Loss, Alveolar Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05612737
• Other study ID #: HORAUG
• Status: Completed
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: October 31, 2021

Study information

• Verified date: November 2022
• Source: Semmelweis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: October 31, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Alveolar Bone Loss
• Bone Augmentation
• Bone Loss, Alveolar

Intervention

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.

Locations

Country	Name	City	State
Hungary	Semmelweis University Department of Periodontology	Budapest

Sponsors (3)

Lead Sponsor	Collaborator
Semmelweis University	FORM-Lab, Purgo Biologics Inc.

Country where clinical trial is conducted

Hungary, 

References & Publications (6)

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. — View 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. — View Citation

Gheno E, Alves GG, Ghiretti R, Mello-Machado RC, Signore A, Lourenço ES, Leite PEC, Mourão 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). pii: 1474. doi: 10.3390/ma15041474. — View 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. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Amount of soft tissue by means of histomorphometry	The percentage of soft tissue of the augmented site within the biopsy	5 months postoperatively
Primary	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	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
Secondary	CBCT analysis	Horizontal bone volume gain (measured in mm) evaluated on pre- and postoperative CBCT-s.	5 months postoperatively
Secondary	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
Secondary	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