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Bone AugmentationNCT05612737

Evaluation of a Novel Horizontal Ridge Augmentation Technique in Dentistry

A study testing Horizontal bone augmentation in people with Bone Augmentation and Bone Loss, Alveolar, run by Semmelweis University at 1 site in Hungary.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Bone Augmentation, Bone Loss, Alveolar
What is being tested?
Horizontal bone augmentation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
1 siteHungary
Study dates
1 Oct 2019to 31 Oct 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • pregnancy
  • smoking
  • uncontrolled diabetes
  • systemic diseases or drug consumption affecting bone metabolism, and clinically relevant osteoporosis

Trial locations and contacts

1 site in 1 country.

Hungary1 site

  • Semmelweis University Department of Periodontology

    Budapest, 1088

Other trials in Hungary

About this study

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

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.

Read the 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.

Being tested
Horizontal bone augmentation
Keywords
platelet concentrate, horizontal bone augmentation, "sticky bone", Histology, Raman spectroscopy
Medical subject headings
Alveolar Bone Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Horizontal bone augmentationProcedure or surgery

    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.

Study groups in NCT05612737
Study groupRoleWhat they receive
"Sticky bone" and tenting screwExperimentalNot described
Receives: Procedure: Horizontal bone augmentation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Amount of newly formed bone by means of histomorphometry

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

    Measured: 5 months postoperatively

  2. 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

    Measured: 5 months postoperatively

  3. Amount of soft tissue by means of histomorphometry

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

    Measured: 5 months postoperatively

  4. 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

    Measured: 5 months postoperatively

Secondary outcomes (4)

  1. 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.

    Measured: 5 months postoperatively

  2. CBCT analysis

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

    Measured: 5 months postoperatively

  3. 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.

    Measured: 5 months postoperatively

  4. 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.

    Measured: 5 months postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Nov 2022
  2. Study start1 Oct 2019
  3. Primary completion30 Apr 2021
  4. Study completion31 Oct 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
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)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05612737
Sponsor's protocol ID
HORAUG
Status last verified
Nov 2022
First submitted
30 Oct 2022
Last updated
10 Nov 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 23593623

  • 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.

    PubMed 26009921

  • 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.

    PubMed 22211303

  • 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.

    PubMed 34328475

  • 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.

    PubMed 35208017

  • 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.

    PubMed 24945603

Questions about this trial

What is this clinical trial studying?

A study testing Horizontal bone augmentation in people with Bone Augmentation and Bone Loss, Alveolar, run by Semmelweis University at 1 site in Hungary.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Amount of newly formed bone by means of histomorphometry (time frame: 5 months postoperatively). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05612737, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2022.

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