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Evaluation of a Novel Horizontal Ridge Augmentation Technique in Dentistry

Primary Purpose

Bone Augmentation, Bone Loss, Alveolar

Status
Completed
Phase
Not Applicable
Locations
Hungary
Study Type
Interventional
Intervention
Horizontal bone augmentation
Sponsored by
Semmelweis University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bone Augmentation focused on measuring platelet concentrate, horizontal bone augmentation, "sticky bone", Histology, Raman spectroscopy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Semmelweis University Department of Periodontology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

"Sticky bone" and tenting screw

Arm Description

Outcomes

Primary Outcome Measures

Amount of newly formed bone by means of histomorphometry
The percentage of newly formed bone of the augmented site within the biopsy
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
Amount of soft tissue by means of histomorphometry
The percentage of soft tissue of the augmented site within the biopsy
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

Secondary Outcome Measures

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.
CBCT analysis
Horizontal bone volume gain (measured in mm) evaluated on pre- and postoperative CBCT-s.
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.
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.

Full Information

First Posted
October 30, 2022
Last Updated
November 4, 2022
Sponsor
Semmelweis University
Collaborators
Purgo Biologics Inc., FORM-Lab
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1. Study Identification

Unique Protocol Identification Number
NCT05612737
Brief Title
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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
April 30, 2021 (Actual)
Study Completion Date
October 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Semmelweis University
Collaborators
Purgo Biologics Inc., FORM-Lab

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Augmentation, Bone Loss, Alveolar
Keywords
platelet concentrate, horizontal bone augmentation, "sticky bone", Histology, Raman spectroscopy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
"Sticky bone" and tenting screw
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Horizontal bone augmentation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Amount of newly formed bone by means of histomorphometry
Description
The percentage of newly formed bone of the augmented site within the biopsy
Time Frame
5 months postoperatively
Title
Amount of graft material bone by means of histomorphometry
Description
The percentage of graft material (THE Graft; Purgo Biologics Inc.) of the augmented site within the biopsy
Time Frame
5 months postoperatively
Title
Amount of soft tissue by means of histomorphometry
Description
The percentage of soft tissue of the augmented site within the biopsy
Time Frame
5 months postoperatively
Title
The quality of the newly formed tissues by means of histology
Description
The descriptive analyses of the cells and tissue structure of the augmented site within the biopsy
Time Frame
5 months postoperatively
Secondary Outcome Measure Information:
Title
In vivo spectroscopy analyses of the augmented site with a Raman spectrometer device
Description
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
Title
CBCT analysis
Description
Horizontal bone volume gain (measured in mm) evaluated on pre- and postoperative CBCT-s.
Time Frame
5 months postoperatively
Title
The clinical descriptive bone assessment of the augmented bone site
Description
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
Title
The clinical descriptive bone assessment of the augmented bone site
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Semmelweis University Department of Periodontology
City
Budapest
ZIP/Postal Code
1088
Country
Hungary

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23593623
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.
Results Reference
background
PubMed Identifier
26009921
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.
Results Reference
background
PubMed Identifier
22211303
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.
Results Reference
background
PubMed Identifier
34328475
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.
Results Reference
background
PubMed Identifier
35208017
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.
Results Reference
background
PubMed Identifier
24945603
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.
Results Reference
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Evaluation of a Novel Horizontal Ridge Augmentation Technique in Dentistry

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