Evaluation of a Novel Horizontal Ridge Augmentation Technique in Dentistry

NCT05612737 | Completed DMC

• 1 other identifier: HORAUG
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Bone Augmentation; Bone Loss, Alveolar

Keywords

platelet concentrate; horizontal bone augmentation; "sticky bone"; Histology; Raman spectroscopy

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• Amount of soft tissue by means of histomorphometry

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

  5 months postoperatively

• 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 Outcomes (4)

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

  5 months postoperatively

• CBCT analysis

  5 months postoperatively

• The clinical descriptive bone assessment of the augmented bone site

  5 months postoperatively

• The clinical descriptive bone assessment of the augmented bone site

  5 months postoperatively

Study Arms (1)

"Sticky bone" and tenting screw

EXPERIMENTAL

Procedure: Horizontal bone augmentation

Interventions

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.

"Sticky bone" and tenting screw

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Semmelweis University: lead
• Purgo Biologics Inc.: collaborator
• FORM-Lab: collaborator

Study Sites (1)

Semmelweis University Department of Periodontology

Budapest, 1088, Hungary

Location

Related Publications (6)

• 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.

  PMID: 23593623 BACKGROUND

• 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.

  PMID: 26009921 BACKGROUND

• 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.

  PMID: 22211303 BACKGROUND

• 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.

  PMID: 34328475 BACKGROUND

• 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.

  PMID: 35208017 BACKGROUND

• 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.

  PMID: 24945603 BACKGROUND

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: All subjects undergo the same type of horizontal bone augmentation using "sticky bone" (combination of xenograft and autologous platelet rich concentrate) and tenting screws.

Study Record Dates

• First Submitted: October 30, 2022
• First Posted: November 10, 2022
• Study Start: October 1, 2019
• Primary Completion: April 30, 2021
• Study Completion: October 31, 2021
• Last Updated: November 10, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)