Comparison of the Use of Natural and Synthetic Bone Substitutes in Dental Implants
NCT ID: NCT05938114
Last Updated: 2023-11-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
34 participants
INTERVENTIONAL
2024-01-31
2024-07-31
Brief Summary
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The main question it aims to answer:
Is there a difference between natural (Bio-Oss®) and synthetic (Bonalive®) bone substitutes in preserving the alveolar ridge dimensions based on changes in the width of the alveolar ridge (expressed in millimetres) from augmentation (baseline) to 24-week follow-up (post augmentation)?
Participants will have a tooth extraction and a bone substitute will be inserted into their socket immediately after. Participants will be divided into two equal groups and those in group A will receive Bio-Oss® while those in group B will receive Bonalive®. In both groups measurements of the alveolar bone will be taken when the bone substitute is inserted and 24 weeks after the insertion of the bone substitute. These measurements will be used to compare the effectiveness of Bio-Oss® and Bonalive in preserving the alveolar bone of a tooth after an extraction.
Detailed Description
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The University of Central Lancashire will lead the study in collaboration with Imperial College London and dental clinics in Midlands, Southeast and Northwest England. We will recruit 34 patients who require tooth extractions and divide them into two equal groups. Patients in group A will receive Bio-Oss® , while those in group B will receive Bonalive® For both groups, the bone substitute will be inserted immediately after an extraction, and the socket will be sealed with a membrane sutured in place. Patients in both groups will be reviewed after 2 weeks to remove the suture. Patients will have another review at 24 weeks, during which the researcher will take a scan or mould, a photograph, and a small biopsy sample of the area where the bone substitute was placed. Measurements obtained at the 24-week follow-up will be used to evaluate the effectiveness and differences between natural and synthetic bone substitutes in preserving the bone supporting a tooth after an extraction.
The results of this pilot study will inform the design and implementation of a full-scale randomised controlled trial to investigate the effectiveness of bioactive glass-derived bone compared with bovine-derived bone in preserving the alveolar bone of a tooth after an extraction
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Group A (Bonalive®)
The test bone substitute is Bonalive®, bioactive glass S53P4, which contains SiO2, Na2O, CaO, and P2O5 (granule size 0.5-0.8mm). Bonalive® is osteoconductive, meaning that it has the ability of promoting bone growth across the granules and the grafting area and slowly replace it with new bone over time. Bonalive® is osteostimulative and has antibacterial properties
Bonalive
Bonalive® is a bioactive glass synthetic bone substitute material that has been shown to have a low substitution rate and antibacterial properties. It has been used successfully in the orthopaedics, craniofacial and ear nose and throat (ENT) specialities for the treatment of osteomyelitis, sinusitis and bony cyst cavities. There have also been a few maxillofacial surgery case reports on its usage in the jaws.
Group B ( Bio-Oss®)
The comparator is Bio-Oss®, deproteinized bovine bone granules (granule size 0.25- 1mm). Bio-Oss® is osteoconductive, which means it acts as a scaffold only for new bone to grow.
Bio-Oss®
Bio-Oss® is a bovine xenogeneic bone graft substitute that is widely used in regenerative dentistry. Bio-Oss® is very similar to human bone in its structure and chemical make-up. The material's porosity allows for vascularisation and new bone formation.
Interventions
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Bonalive
Bonalive® is a bioactive glass synthetic bone substitute material that has been shown to have a low substitution rate and antibacterial properties. It has been used successfully in the orthopaedics, craniofacial and ear nose and throat (ENT) specialities for the treatment of osteomyelitis, sinusitis and bony cyst cavities. There have also been a few maxillofacial surgery case reports on its usage in the jaws.
Bio-Oss®
Bio-Oss® is a bovine xenogeneic bone graft substitute that is widely used in regenerative dentistry. Bio-Oss® is very similar to human bone in its structure and chemical make-up. The material's porosity allows for vascularisation and new bone formation.
Eligibility Criteria
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Inclusion Criteria
* Single units in a dentate patient
* Non-surgical extraction - no flap raised, and no bone removed Intact socket walls post-extraction
* Bleeding sockets
* Stable periodontal health
Exclusion Criteria
* Presence of active periodontal disease
* Socket walls not intact - \>50% bone loss in any of the four walls
* Sclerotic sockets post-extraction - the socket does not fill up with blood post-extraction
* Denture wearer - the extraction socket site under the load of a denture
* Patients on medication that can affect bone healing e.g., bisphosphonates (oral or intravenous), selective serotonin reuptake inhibitors (SSRI), methotrexate, proton pump inhibitors (PPI)
* Uncontrolled diabetes Smokers Immunosuppressed Patients
* Patients with a history of myocardial Infarction in the last year ASA Class \> II patients
18 Years
ALL
Yes
Sponsors
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Imperial College London
OTHER
University of Central Lancashire
OTHER
Responsible Party
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Fadi Barrak
Course Lead and Senior Lecturer, University of Central Lancashire, School of Dentistry
Principal Investigators
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Ihtesham Rehman, PhD
Role: STUDY_CHAIR
University of Central Lancashire
Locations
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University of Central Lanchashire
Preston, Lancashire, United Kingdom
Devonshire House Dental Practice
Cambridge, , United Kingdom
St Faith's Dental Clinic,
East Grinstead, , United Kingdom
Halesowen Dental
Halesowen, , United Kingdom
Imperical College,London
London, , United Kingdom
UCLan community Dentists
Preston, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Ihtesham Rehman, PhD MSc BSc
Role: primary
FADI BARRAK, MBBS BDS
Role: backup
Wail Girgis
Role: primary
Gerry Van Deventer
Role: primary
Manoj Bhatia
Role: primary
JULIAN JONES, PhD MEng
Role: primary
Siwei Li, PhD MSc MEng
Role: backup
Fadi Barrak, MBBS; BDS
Role: primary
References
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Solakoglu O, Gotz W, Heydecke G, Schwarzenbach H. Histological and immunohistochemical comparison of two different allogeneic bone grafting materials for alveolar ridge reconstruction: A prospective randomized trial in humans. Clin Implant Dent Relat Res. 2019 Oct;21(5):1002-1016. doi: 10.1111/cid.12824. Epub 2019 Aug 19.
Rignon-Bret C, Hadida A, Aidan A, Nguyen TH, Pasquet G, Fron-Chabouis H, Wulfman C. Efficacy of bone substitute material in preserving volume when placing a maxillary immediate complete denture: study protocol for the PANORAMIX randomized controlled trial. Trials. 2016 May 20;17(1):255. doi: 10.1186/s13063-016-1380-7.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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IRAS ID: 316275
Identifier Type: OTHER
Identifier Source: secondary_id
HEALTH 01032
Identifier Type: -
Identifier Source: org_study_id