Alveolar Ridge AugmentationBSNSNCT05938114
Comparison of the Use of Natural and Synthetic Bone Substitutes in Dental Implants
A study testing Bonalive and Bio-Oss® in people with Alveolar Ridge Augmentation, run by University of Central Lancashire at 6 sites in United Kingdom.
Trial summary
The goal of this clinical trial is to compare the effectiveness of a natural and synthetic bone substitute in preserving the alveolar ridge (bone) of a single- rooted tooth after an extraction. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alveolar Ridge Augmentation
- What is being tested?
- Bonalive and Bio-Oss®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 6 sitesUnited Kingdom
- Study dates
- Jan 2024to Jul 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients (age >18) in need of extraction of a single-rooted tooth attending the clinics selected for the study
- 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
Who cannot join
- Multiple adjacent extractions
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United Kingdom6 sites
Devonshire House Dental Practice
Cambridge, CB1 7PN
Wail Girgis
St Faith's Dental Clinic,
East Grinstead, RH19 1PN
Gerry Van Deventer
Halesowen Dental
Halesowen, B63 3NQ
Manoj Bhatia
Imperical College,London
London, SW7 2AZ
JULIAN JONES, PhD MEng, julian.r.jones@imperial.ac.uk
Siwei Li, PhD MSc MEng, siwei.li@vssacademy.co.uk
University of Central Lanchashire
Preston, Lancashire, PR1 2HE
Ihtesham Rehman, PhD MSc BSc, +44 (0)7956441535, IURehman@uclan.ac.uk
FADI BARRAK, MBBS BDS, +44 (0) 7949017438, fnbarrak@uclan.ac.uk
UCLan community Dentists
Preston, PR1 2HE
Fadi Barrak, MBBS; BDS, +441772201201 ext. 5911, fnbarrak@uclan.ac.uk
About this study
Official title: Effectiveness of Two Bone Substitutes, Natural and Synthetic, in Preserving the Alveolar Ridge of Single-rooted Teeth: a Pilot Single-blind, Parallel Randomised Controlled Trial
The goal of this clinical trial is to compare the effectiveness of a natural and synthetic bone substitute in preserving the alveolar ridge (bone) of a single- rooted tooth after an extraction.
The main question it aims to answer:
Read more
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.
Read the detailed description
It is a pilot single-blind two-arm parallel randomised control trial that aims to assess the differences between two bone substitutes, natural versus synthetic. The study will mimic the routine practice, and patients will be randomly allocated to receive either natural (control) or synthetic (intervention) bone substitutes. The patient follow-up period will be 24 weeks from the baseline data collection point.
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
- Alveolar Ridge Augmentation
- Being tested
- Bonalive, Bio-Oss®
- Keywords
- Ridge Preservation, Bone Substitutes, Alveolar Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BonaliveOther
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®Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A (Bonalive®) | Experimental | 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 Receives: Other: Bonalive |
| Group B ( Bio-Oss®) | Active comparator | 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. Receives: Other: Bio-Oss® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome measure is the change in the width of the alveolar ridge
The change in the width of the alveolar ridge is expressed in millimetres and it will be obtained using intra-oral scanners (this does not involve radiographs) or impressions and clinical photographs.
Measured: Outcome data will be collected at baseline and week 24
Secondary outcomes (3)
Change in height of the alveolar bone.
The change in height of the alveolar bone expressed in millimetres. Assessment will be done using the periapical radiographs taken pre-extraction and at 24-week follow-up and intra-oral scanners (this does not involve radiographs) or impressions and clinical photographs.
Measured: This outcome data will be collected at baseline and at week 24
Changes in the vertical crestal bone level
The change in the vertical crestal bone level is expressed in millilitres and it will be assessed with periapical radiographs taken pre-extraction and 24-week post augmentation.
Measured: This outcome data will be collected at baseline and at week 24
Presence of bone around the alveolar ridge Concentration (in nanograms) of gene expression for bone markers
The presence of bone around the alveolar ridge will be assessed using histology (qualitative assessment of bone infiltration)
A Polymerase Chain Reaction (PCR) test will be done to determine the concentration (in nanograms) of gene expression for bone markers (including osteopontin, osteocalcin) at 24-week post augmentation.
Measured: Outcome data will be obtained at week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2023
- Study startJan 2024 (estimated)
- Primary completionJul 2024 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alveolar Ridge AugmentationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Central Lancashire
- Sponsor type
- University, hospital or other
- Collaborators
- Imperial College London
- Responsible party
- Principal investigator, Fadi Barrak, University of Central Lancashire
- Investigators
- Ihtesham Rehman, PhD, Study chair, University of Central Lancashire
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05938114
- Sponsor's protocol ID
- HEALTH 01032
- Other IDs
- IRAS ID: 316275
- Acronym
- BSNS
- Status last verified
- Nov 2023
- First submitted
- 30 Jun 2023
- Last updated
- 30 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data obtained from each participant will be anonymised at their last dental visit and any identifiable paper records, except consent forms, will be securely destroyed. The fully anonymised data set will be available in perpetuity to other researchers in the UCLanData OA repository under the open data policy.
Publications
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.
PubMed 31424173Rignon-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.
PubMed 27206923
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Two Bone Substitutes, Natural and Synthetic, in Preserving the Alveolar Ridge of Single-rooted Teeth: a Pilot Single-blind, Parallel Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05938114
- Acronym / sponsor ID
- BSNS / HEALTH 01032
- Conditions
- Alveolar Ridge Augmentation
- Keywords
- Ridge Preservation, Bone Substitutes, Alveolar Bone
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- University of Central LancashireUniversity, hospital or other
- Collaborators
- Imperial College London
- Study start
- Jan 2024 (estimated)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 10 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to compare the effectiveness of a natural and synthetic bone substitute in preserving the alveolar ridge (bone) of a single- rooted tooth after an extraction.
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
It is a pilot single-blind two-arm parallel randomised control trial that aims to assess the differences between two bone substitutes, natural versus synthetic. The study will mimic the routine practice, and patients will be randomly allocated to receive either natural (control) or synthetic (intervention) bone substitutes. The patient follow-up period will be 24 weeks from the baseline data collection point.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (Bonalive®) | Experimental | Other: BonaliveThe 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 |
| Group B ( Bio-Oss®) | Active comparator | Other: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patients (age >18) in need of extraction of a single-rooted tooth attending the clinics selected for the study
- 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
Key exclusion criteria (8 listed)
- Multiple adjacent extractions
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BonaliveBonalive® 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. | Other | Group A (Bonalive®) |
| 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. | Other | Group B ( Bio-Oss®) |
Primary outcome
Primary outcome measure is the change in the width of the alveolar ridge
Time frame: Outcome data will be collected at baseline and week 24
The change in the width of the alveolar ridge is expressed in millimetres and it will be obtained using intra-oral scanners (this does not involve radiographs) or impressions and clinical photographs.
3 secondary outcomes
Change in height of the alveolar bone.
Time frame: This outcome data will be collected at baseline and at week 24
Changes in the vertical crestal bone level
Time frame: This outcome data will be collected at baseline and at week 24
Presence of bone around the alveolar ridge Concentration (in nanograms) of gene expression for bone markers
Time frame: Outcome data will be obtained at week 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
- Background: PubMed 31424173Solakoglu 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.
- Background: PubMed 27206923Rignon-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.
- Individual participant dataSharing planned: Yes. All data obtained from each participant will be anonymised at their last dental visit and any identifiable paper records, except consent forms, will be securely destroyed. The fully anonymised data set will be available in perpetuity to other researchers in the UCLanData OA repository under the open data policy.
Related trials for Alveolar Ridge Augmentation
Active, not recruiting
Alveolar Ridge Reconstruction in Post-extraction Sites Using a Magnesium Resorbable Membrane. An Explorative Study
Bone Augmentation, Alveolar Ridge Augmentation
Active, not recruiting
L-PRF Block vs Composite Graft for Horizontal Ridge Augmentation
Alveolar Ridge Resorption After Extraction, Alveolar Bone Loss
Recruiting
Two Bovine Xenografts in Lateral Window Sinus Augmentation With or Without Bone Marrow Blood
Alveolar Bone Loss, Sinus Floor Augmentation
Not yet recruiting
Autogenous and Xenograft Bone Mix in Alveolar Ridge Reconstruction
Horizontal Alveolar Ridge Deficiency
Not yet recruiting
Comparison of Three Autogenous Bone and Xenograft Ratios for Horizontal Ridge Augmentation
Horizontal Alveolar Ridge Deficiency
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ihtesham Rehman, PhD study chair
University of Central Lancashire
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bonalive and Bio-Oss® in people with Alveolar Ridge Augmentation, run by University of Central Lancashire at 6 sites in United Kingdom.
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 5 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 30 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact FADI BARRAK, MBBS; BDS (+441772201201 ext. 5911, fnbarrak@uclan.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary outcome measure is the change in the width of the alveolar ridge (time frame: Outcome data will be collected at baseline and week 24). 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 NCT05938114, which also lists 2 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 30 Nov 2023.