Evaluation of a Novel Horizontal Ridge Augmentation Technique in Dentistry

Not Applicable

Completed

• Conditions: Bone Augmentation; Bone Loss, Alveolar
• Interventions: Procedure: Horizontal bone augmentation

• Registration Number: NCT05612737
• Lead Sponsor: Semmelweis University

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 Timeline

• Study Start: 2019-10-01
• Primary Completion: 2021-04-30
• Study Completion: 2021-10-31
• Study First Submitted: 2022-10-30
• Status Verified: 2022-11
• Study First Submitted QC: 2022-11-04
• Last Update Submitted: 2022-11-04
• Study First Posted: 2022-11-10
• Last Update Posted: 2022-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
"Sticky bone" and tenting screw	Horizontal bone augmentation	-

Primary Outcome Measures

Name	Time	Method
Amount of newly formed bone by means of histomorphometry	5 months postoperatively	The percentage of newly formed bone of the augmented site within the biopsy
Amount of soft tissue by means of histomorphometry	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	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	5 months postoperatively	The percentage of graft material (THE Graft; Purgo Biologics Inc.) of the augmented site within the biopsy

Secondary Outcome Measures

Name	Time	Method
The clinical descriptive bone assessment of the augmented bone site	5 months postoperatively	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.
In vivo spectroscopy analyses of the augmented site with a Raman spectrometer device	5 months postoperatively	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	5 months postoperatively	Horizontal bone volume gain (measured in mm) evaluated on pre- and postoperative CBCT-s.

Trial Locations

Locations (1)

Semmelweis University Department of Periodontology; 🇭🇺 Budapest, Hungary