Histological Analysis of Osteogenic Potential of Biphasic Calcium Phosphate

NCT06020092 | Completed Phase 4 DMC

• 1 other identifier: 2158-61-46-22-109
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Bone healing after tooth extraction may be affected by defects in the buccal wall of the alveolus, such as fenestrations and dehiscences. Therefore, it is advisable to perform a surgical procedure such as guided bone regeneration after tooth extractions. Different biomaterials are used for this purpose. The aim of this study is to investigate the qualitative and quantitative histological changes in human biopsies taken after 6 months of healing of extraction sockets with buccal wall defects. For this purpose, the defects of 36 patients (18 per group) will be augmented with injectable biphasic calcium phosphate (I-BCP) or bovine xenograft (BX) after extraction. After six months of healing, bone biopsies will be taken and processed to the qualitative and quantitative histological analysis.

Conditions

Alveolar Ridge Enlargement; Fenestration; Dehiscence

Keywords

bone regeneration; alloplast; bovine xenograft; guided bone regeneration

Outcome Measures

Primary Outcomes (1)

• Percentage of the newly formed bone, soft tissue and residual biomaterial in bone biopsies harvested 6 months after bone augmentation

  Histomorphometric processing of the specimens will be performed using the free ImageJ software (https://imagej.nih.gov/ij/download.html). The surface of the new bone, the surface of the biomaterial, and the surface of the soft tissue will be marked on the specimens. Marked surfaces of the specimen will be then measured, and the following will be calculated from the data obtained: percentage of new bone formed, percentage of biomaterial remaining, and percentage of soft tissue

  Up to 8 months

Other Outcomes (1)

• Qualitative histological assessment

  Up to 8 months

Study Arms (2)

Injectable biphasic calcium phosphate (maxresorb inject, botiss GmbH)

EXPERIMENTAL

This biomaterial is an alloplastic bone substitute material in the form of a paste that is placed into the defect with a plastic syringe. The material consists of an aqueous gel containing granules of biphasic calcium phosphate in the composition of 60% HA and 40% β-TCP (particle size between 15-50 nm).

Procedure: Bone augmentation with I-BCP

Bovine xenograft (cerabone, botiss GmbH)

ACTIVE COMPARATOR

The material is completely anorganic and consists of 100% HA. For this study, the material will be used in granular form (the size of the granules is between 0.5 and 1 mm), mixed with physiological solution prior to placement into the defect.

Procedure: Bone augmentation with BX

Interventions

Bone augmentation with I-BCP PROCEDURE

The extraction socket will be filled after tooth extraction with I-BCP, in order to achieve bone regeneration and prevent volume loss after tooth extraction.

Injectable biphasic calcium phosphate (maxresorb inject, botiss GmbH)

Bone augmentation with BX PROCEDURE

The extraction socket will be filled after tooth extraction with BX, in order to achieve bone regeneration and prevent volume loss after tooth extraction.

Bovine xenograft (cerabone, botiss GmbH)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• age between 18 and 60 years
• patients requires to have at least one tooth predisposed to extraction
• intact physical and mental health
• patient must understand the study protocol
• patient must sign an informed consent.
• the presence of a buccal bone defect such as fenestration or dehiscence.

You may not qualify if:

• patients will be excluded from the study if they had at least one of the absolute contraindications to implant prosthetic therapy
• following systemic diseases: uncontrolled diabetes, osteoporosis and osteopenia, and vitamin D deficiency
• bisphosphonate therapy
• glucocorticoid therapy
• hypothyroidism
• uncontrolled cardiovascular disease (hypertension, coronary artery disease, congestive heart failure)
• pregnant or lactating women
• following local factors: use of tobacco products (up to 10 cigarettes per day) and poor oral hygiene

Sponsors & Collaborators

• Josip Juraj Strossmayer University of Osijek: lead

Study Sites (1)

Faculty of Medicine Osijek

Osijek, County of Osijek-Baranja, 31000, Croatia

Location

Related Publications (2)

• Candrlic M, Peric Kacarevic Z, Ivanisevic Z, Tomas M, Vcev A, Faj D, Matijevic M. Histological and Radiological Features of a Four-Phase Injectable Synthetic Bone Graft in Guided Bone Regeneration: A Case Report. Int J Environ Res Public Health. 2020 Dec 29;18(1):206. doi: 10.3390/ijerph18010206.

  PMID: 33383971 BACKGROUND

• Tomas M, Candrlic M, Juzbasic M, Ivanisevic Z, Matijevic N, Vcev A, Cvijanovic Peloza O, Matijevic M, Peric Kacarevic Z. Synthetic Injectable Biomaterials for Alveolar Bone Regeneration in Animal and Human Studies. Materials (Basel). 2021 May 26;14(11):2858. doi: 10.3390/ma14112858.

  PMID: 34073551 BACKGROUND

MeSH Terms

Interventions

benzo(c)phenanthrene-5,6-imine

Study Officials

• Marija Candrlic, PhD

  Faculty of Medicine Osijek

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral researcher at Department of Dental Medicine

Study Record Dates

• First Submitted: August 10, 2023
• First Posted: August 31, 2023
• Study Start: July 31, 2021
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: August 31, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)