Histological Analysis of Osteogenic Potential of Biphasic Calcium Phosphate
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ClinicalTrials.gov Identifier: NCT06020092 |
Recruitment Status :
Completed
First Posted : August 31, 2023
Last Update Posted : August 31, 2023
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Condition or disease | Intervention/treatment | Phase |
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Alveolar Ridge Enlargement Fenestration Dehiscence | Procedure: Bone augmentation with I-BCP Procedure: Bone augmentation with BX | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 36 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Histological Analysis of Osteogenic Potential of Biphasic Calcium Phosphate in Alveolar Ridge Augmentation |
Actual Study Start Date : | July 31, 2021 |
Actual Primary Completion Date : | July 31, 2023 |
Actual Study Completion Date : | July 31, 2023 |
Arm | Intervention/treatment |
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Experimental: Injectable biphasic calcium phosphate (maxresorb inject, botiss GmbH)
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).
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Procedure: Bone augmentation with I-BCP
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. |
Active Comparator: Bovine xenograft (cerabone, botiss GmbH)
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.
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Procedure: Bone augmentation with BX
The extraction socket will be filled after tooth extraction with BX, in order to achieve bone regeneration and prevent volume loss after tooth extraction. |
- Percentage of the newly formed bone, soft tissue and residual biomaterial in bone biopsies harvested 6 months after bone augmentation [ Time Frame: Up to 8 months ]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
- Qualitative histological assessment [ Time Frame: Up to 8 months ]Tissue response to implanted biomaterial is assessed by descriptive histologic evaluation, i.e., the presence of fibroblasts, blood vessels, neutrophils, monocytes/macrophages, and multinucleated giant cells (MGC).
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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06020092
Croatia | |
Faculty of Medicine Osijek | |
Osijek, Osijek Baranja, Croatia, 31000 |
Principal Investigator: | Marija Candrlic, PhD | Faculty of Medicine Osijek |
Responsible Party: | Marija Čandrlić, Postdoctoral researcher at Department of Dental Medicine, Josip Juraj Strossmayer University of Osijek |
ClinicalTrials.gov Identifier: | NCT06020092 |
Other Study ID Numbers: |
2158-61-46-22-109 |
First Posted: | August 31, 2023 Key Record Dates |
Last Update Posted: | August 31, 2023 |
Last Verified: | August 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | I do not plan to make IPD available to other researchers. IPDs will be administrated and stored by one person. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
bone regeneration alloplast bovine xenograft guided bone regeneration |
Hypertrophy Pathological Conditions, Anatomical |