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Completed

NCT Number: NCT05612737

Evaluation of a Novel Horizontal Ridge Augmentation Technique in Dentistry

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Semmelweis University Department of Periodontology

Budapest, 1088, Hungary

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Horizontal bone augmentation

Procedure

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 outcomes

  1. Amount of newly formed bone by means of histomorphometry

    Time frame: 5 months postoperatively

    The percentage of newly formed bone of the augmented site within the biopsy

  2. Amount of graft material bone by means of histomorphometry

    Time frame: 5 months postoperatively

    The percentage of graft material (THE Graft; Purgo Biologics Inc.) of the augmented site within the biopsy

  3. Amount of soft tissue by means of histomorphometry

    Time frame: 5 months postoperatively

    The percentage of soft tissue of the augmented site within the biopsy

  4. The quality of the newly formed tissues by means of histology

    Time frame: 5 months postoperatively

    The descriptive analyses of the cells and tissue structure of the augmented site within the biopsy

Secondary outcomes

  1. In vivo spectroscopy analyses of the augmented site with a Raman spectrometer device

    Time frame: 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.

  2. CBCT analysis

    Time frame: 5 months postoperatively

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

  3. The clinical descriptive bone assessment of the augmented bone site

    Time frame: 5 months postoperatively

    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.

  4. The clinical descriptive bone assessment of the augmented bone site

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Semmelweis University

Other

Collaborators

  • FORM-Lab
  • Purgo Biologics Inc.

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Nov 10, 2022
Registry last updated
Nov 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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