Bone LossNCT04789759
Biomaterial Clinical Performance in a Socket Preservation Model
A study testing Socket Preservation - Bond Apatite synthetic bone substitute and Socket healing - No Filler in people with Bone Loss and Alveolar Bone Resorption, run by International Advanced Dentistry, Lisbon.
Trial summary
When a dental extraction is performed, sequential cascade of events happens that lead to a modeling and remodeling of the area. This phenomenon leads to bone resorption and consequential volume loss atrophy. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bone Loss, Alveolar Bone Resorption
- What is being tested?
- Socket Preservation - Bond Apatite synthetic bone substitute and Socket healing - No Filler
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2021to 1 Aug 2022
- 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
- Aged 18 or over
- requiring extraction of teeth in the premolar region and anterior maxilla (15-25), presence of intact 2/3 or less, buccal bone plate
- ASA (Physical Status Classification System, American Society of Anesthesiologist) I or II.
Who cannot join
- patients with uncompensated systemic diseases, metabolic and healing disorders, i.e. diabetes mellitus, hyperparathyroidism, cancer, HIV,
- heavy smokers (>5 cigarettes/ day),
- bone metabolic diseases,
- severe renal dysfunction or liver disease,
- had received systemic corticosteroids or other immunosuppressive agents, radiation therapy and/or chemotherapy for the past 2 months,
- active infections in the surgical site
- patients with periodontal or/and endodontic disease
Trial locations and contacts
No sites are listed yet.
Joana Borges contact
About this study
Official title: Comparative Clinical Performance of Biphasic Calcium Sulfate Cement Matrix With Hydroxyapatite Granules in a Socket Preservation Model: a Pilot Clinical Trial Parallel Group Assignment
When a dental extraction is performed, sequential cascade of events happens that lead to a modeling and remodeling of the area.
This phenomenon leads to bone resorption and consequential volume loss atrophy. In literature several biomaterials (Autogenous, alloplastic, allografts and xenografts) were tested as alveolar fillers with the aim of controlling this physiologic event.
Read more
Socket preservation is today a very widely spread dental technic to preserve the alveolar dimensions, that uses a wide range of biomaterials.
Alloplastic materials have a fair evidence to work in several regenerative procedures in the oral and maxillofacial region.
This pilot trial aims to characterize Histologic bone healing pattern in a human socket preservation model of 2/3 biphasic calcium sulfate cement matrix's and Hydroxyapatite (HA granules).
Alterations in Volumetric alveolar socket changes in a socket preservation clinical model will also be studied.
Read the detailed description
Aim : To evaluate histologic performance and volumetric outcome of a bone substitute used in dentistry for guided bone regeneration procedures.
Model : Human Socket preservation surgery with a control group of spontaneous alveolar healing.
Inclusion criteria includes a class 2 or 3 (loss of at least 1/3 of the buccal bone of the alveolar socket) post-extraction sockets.
Clinical Experimental Methodology :
Atraumatic extraction of the hopeless tooth without flap retraction, after socket mechanical debridement , fill with 2/3 biphasic calcium sulfate cement matrix's with Hydroxyapatite (HA granules) and covered with a resorbable membrane.
3 Month after a CBCT is performed for implant planning.
At implant placement a 2 mm trephine will be used for core extraction.
Measurements (Stl File) on the day of surgery (Baseline T0) and at implant placement (3 month after tooth extraction) (T1) and after delivery final crown (T2).
Discrepancy (Trueness) Between STL Files in Teeth Adjacent to Implant will be used at T0, T1 and T2.
Histologic measure comprise percentage of vital bone formation, fibrous/connective tissue, and material remnant, in a socket preservation model
To Measure Volumetric changes reverse engineering software (Geomagic Control X, 3D Systems) will be used.
Other evaluation parameters involve radiographic Cone Beam Computer Tomography evaluation, primary stability, implant survival and implant success rate
Clinical Control Methodology :
Atraumatic extraction of the hopeless tooth without flap retraction, after socket mechanical debridement Measurements (Stl File) on the day of surgery (Baseline T0) and at 3 month after tooth extraction) (T1) Discrepancy (Trueness) Between Standard Tessellation Language Files in Teeth Adjacent to Implant will be used at T0 and T1
- Conditions
- Bone Loss, Alveolar Bone Resorption
- Being tested
- Socket Preservation - Bond Apatite synthetic bone substitute, Socket healing - No Filler
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Socket Preservation - Bond Apatite synthetic bone substituteDevice
Also called alveolar regeneration, bone regeneration
Pre-op CBCT scanner for evaluating bone conditions around hopeless tooth. If 1/3 of the buccal plate is missing, considered a class 2 alveolar socket.
Extraction of tooth and place 2/3 biphasic calcium sulfate cement matrix's with Hydroxyapatite (HA granules) , condensed , and covered with a resorbable membrane suture to the adjacent tissue.
At implant placement ,take bone for histological preparation and histomorphometric analysis of the healing pattern.
At T0, T1 and T2 measure adjacent teeth periodontal status , Probing Depth , bleeding on probing.
Volumetric measurements, will use fixed landmarks (ex. adjacent teeth) to calibrate the STL measurements. Calculate the difference between pre-extraction socket and the post treatment with the alloplastic material.
Primary and secondary stability will be measured by ISQ units with a RFA machine, that will include the machine to measure and the magnetic tip to be screwed in the implant platform.
Socket healing - No FillerProcedure or surgery
Also called Alveolar Socket spontaneous healing
Pre-op CBCT scanner for evaluating bone conditions around hopeless tooth, at extraction day, no flap opening , atraumatic extraction, no biomaterial filler, At T0, T2 measure adjacent teeth periodontal status , Probing Depth , bleeding on probing.
Volumetric measurements will include an intramural scanner from all the stages , we will use fixed landmarks (ex. adjacent teeth) to calibrate the STL measurements. Calculate the difference between pre-extraction socket and the post treatment with the alloplastic material.
| Study group | Role | What they receive |
|---|---|---|
| Socket Preservation Alloplastic Material | Experimental | 10 Consecutive Patients with hopeless teeth and 1/3 or more buccal bone resorption will be placed in a therapy go bone regeneration called socket preservation technique.
The surgery will include placement of 2/3 biphasic calcium sulfate cement matrix's with hydroxyapatite (HA granules) to fill the alveolar defects, and place a resorbable membrane sutured to adjacent tissue, to avoid material leakage.
No flap retraction. 3 Month later an implant will be placed, and a bone biopsy of the healed socket harvested. 2 Month later a final Zirconia ceramic crown screw retained to the osseointegrated implant.
Primary (T0) and Secondary (T1) stability measured with ISQ values.
Intraoral Scanner and an STL File will be taken at T0 , T1 and T2 for volumetric alteration evaluation. Receives: Device: Socket Preservation - Bond Apatite synthetic bone substitute |
| Extraction Socket Spontaneous Healing | Active comparator | 10 Consecutive patients with a tooth extraction without the aim of placing a future implant and without Biomaterial filler placed in the socket. Spontaneous healing Receives: Procedure: Socket healing - No Filler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histologic Examination Histomorphometric Analysis
Histologic measure, percentage of Vital Bone formation, Fibrous/connective tissue, and material remnant present in the sample.
Measured: 3 month after tooth extraction
Secondary outcomes (7)
Volumetric Changes Clinical
Measure Linear changes reverse engineering software (Geomagic Control X, 3D Systems) in mm.
Measured: at pre-extraction and at final crown insertion up to 1 year
Radiographic CBCT - Bone evaluation
Measure Linear changes in bone from T0 baseline to Implant Placement T1 in mm
Measured: at pre-extraction and at final crown insertion up to 1 year
Primary and Secondary stability
Measure the Resonance Frequency Analysis at implants placed in regenerated bone
Measured: at implant placement and at dental crown insertion up to 1 year
Incidence of Implant Success rate
Measure implant status peri-implant parameters , bleeding on probing in percentage of sites
Measured: at final treatment (crown insertion) up to 1 year
Implant probing depth
Measure the attachment loss in mm
Measured: At implant insertion and At final treatment (crown insertion) up to 1 year
Implant marginal bone loss.
Measure bone position regarding Implant Platform
Measured: at implant placement and at final crown insertion (up to 1 year)
Incidence of Survival rate
if the implant is osseointegrated
Measured: at dental crown placement (final treatment) up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start1 May 2021 (estimated)
- Primary completion1 May 2022 (estimated)
- Study completion1 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone LossStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Case Series of 10 consecutive cases , with one extraction (at least ) with a type 2 socket, Control group, 10 consecutive dental extractions.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Advanced Dentistry, Lisbon
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Andre Chen, Phd, Principal investigator, International Advanced DentistryJoão Borges, Msc, Study director, International Advanced DentistryElena Cervino, Msc, Study chair, International Advanced DentistryAmos Yahav, DMD, Study chair, Augma BioOfir Yahav, DMD, Study chair, Augma Bio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04789759
- Sponsor's protocol ID
- 001
- Status last verified
- Mar 2021
- First submitted
- 13 Feb 2021
- Last updated
- 10 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Clinical Performance of Biphasic Calcium Sulfate Cement Matrix With Hydroxyapatite Granules in a Socket Preservation Model: a Pilot Clinical Trial Parallel Group Assignment
- ClinicalTrials.gov ID
- NCT04789759
- Acronym / sponsor ID
- 001
- Conditions
- Bone Loss, Alveolar Bone Resorption
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- International Advanced Dentistry, LisbonResearch network
- Study start
- 1 May 2021 (estimated)
- Primary completion
- 1 May 2022 (estimated)
- Study completion
- 1 Aug 2022 (estimated)
- First posted
- 10 Mar 2021 (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.
When a dental extraction is performed, sequential cascade of events happens that lead to a modeling and remodeling of the area.
This phenomenon leads to bone resorption and consequential volume loss atrophy. In literature several biomaterials (Autogenous, alloplastic, allografts and xenografts) were tested as alveolar fillers with the aim of controlling this physiologic event.
Socket preservation is today a very widely spread dental technic to preserve the alveolar dimensions, that uses a wide range of biomaterials.
Alloplastic materials have a fair evidence to work in several regenerative procedures in the oral and maxillofacial region.
This pilot trial aims to characterize Histologic bone healing pattern in a human socket preservation model of 2/3 biphasic calcium sulfate cement matrix's and Hydroxyapatite (HA granules).
Alterations in Volumetric alveolar socket changes in a socket preservation clinical model will also be studied.
Detailed description
Aim : To evaluate histologic performance and volumetric outcome of a bone substitute used in dentistry for guided bone regeneration procedures.
Model : Human Socket preservation surgery with a control group of spontaneous alveolar healing.
Inclusion criteria includes a class 2 or 3 (loss of at least 1/3 of the buccal bone of the alveolar socket) post-extraction sockets.
Clinical Experimental Methodology :
Atraumatic extraction of the hopeless tooth without flap retraction, after socket mechanical debridement , fill with 2/3 biphasic calcium sulfate cement matrix's with Hydroxyapatite (HA granules) and covered with a resorbable membrane.
3 Month after a CBCT is performed for implant planning.
At implant placement a 2 mm trephine will be used for core extraction.
Measurements (Stl File) on the day of surgery (Baseline T0) and at implant placement (3 month after tooth extraction) (T1) and after delivery final crown (T2).
Discrepancy (Trueness) Between STL Files in Teeth Adjacent to Implant will be used at T0, T1 and T2.
Histologic measure comprise percentage of vital bone formation, fibrous/connective tissue, and material remnant, in a socket preservation model
To Measure Volumetric changes reverse engineering software (Geomagic Control X, 3D Systems) will be used.
Other evaluation parameters involve radiographic Cone Beam Computer Tomography evaluation, primary stability, implant survival and implant success rate
Clinical Control Methodology :
Atraumatic extraction of the hopeless tooth without flap retraction, after socket mechanical debridement Measurements (Stl File) on the day of surgery (Baseline T0) and at 3 month after tooth extraction) (T1) Discrepancy (Trueness) Between Standard Tessellation Language Files in Teeth Adjacent to Implant will be used at T0 and T1
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Case Series of 10 consecutive cases , with one extraction (at least ) with a type 2 socket, Control group, 10 consecutive dental extractions.
| Arm | Type | Receives |
|---|---|---|
| Socket Preservation Alloplastic Material | Experimental | Device: Socket Preservation - Bond Apatite synthetic bone substitute10 Consecutive Patients with hopeless teeth and 1/3 or more buccal bone resorption will be placed in a therapy go bone regeneration called socket preservation technique. The surgery will include placement of 2/3 biphasic calcium sulfate cement matrix's with hydroxyapatite (HA granules) to fill the alveolar defects, and place a resorbable membrane sutured to adjacent tissue, to avoid material leakage. No flap retraction. 3 Month later an implant will be placed, and a bone biopsy of the healed socket harvested. 2 Month later a final Zirconia ceramic crown screw retained to the osseointegrated implant. Primary (T0) and Secondary (T1) stability measured with ISQ values. Intraoral Scanner and an STL File will be taken at T0 , T1 and T2 for volumetric alteration evaluation. |
| Extraction Socket Spontaneous Healing | Active comparator | Procedure: Socket healing - No Filler10 Consecutive patients with a tooth extraction without the aim of placing a future implant and without Biomaterial filler placed in the socket. Spontaneous healing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 18 or over
- requiring extraction of teeth in the premolar region and anterior maxilla (15-25), presence of intact 2/3 or less, buccal bone plate
- ASA (Physical Status Classification System, American Society of Anesthesiologist) I or II.
Key exclusion criteria (7 listed)
- patients with uncompensated systemic diseases, metabolic and healing disorders, i.e. diabetes mellitus, hyperparathyroidism, cancer, HIV,
- heavy smokers (>5 cigarettes/ day),
- bone metabolic diseases,
- severe renal dysfunction or liver disease,
- had received systemic corticosteroids or other immunosuppressive agents, radiation therapy and/or chemotherapy for the past 2 months,
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 |
|---|---|---|
| Socket Preservation - Bond Apatite synthetic bone substituteAlso: alveolar regeneration, bone regenerationPre-op CBCT scanner for evaluating bone conditions around hopeless tooth. If 1/3 of the buccal plate is missing, considered a class 2 alveolar socket. Extraction of tooth and place 2/3 biphasic calcium sulfate cement matrix's with Hydroxyapatite (HA granules) , condensed , and covered with a resorbable membrane suture to the adjacent tissue. At implant placement ,take bone for histological preparation and histomorphometric analysis of the healing pattern. At T0, T1 and T2 measure adjacent teeth periodontal status , Probing Depth , bleeding on probing. Volumetric measurements, will use fixed landmarks (ex. adjacent teeth) to calibrate the STL measurements. Calculate the difference between pre-extraction socket and the post treatment with the alloplastic material. Primary and secondary stability will be measured by ISQ units with a RFA machine, that will include the machine to measure and the magnetic tip to be screwed in the implant platform. | Device | Socket Preservation Alloplastic Material |
| Socket healing - No FillerAlso: Alveolar Socket spontaneous healingPre-op CBCT scanner for evaluating bone conditions around hopeless tooth, at extraction day, no flap opening , atraumatic extraction, no biomaterial filler, At T0, T2 measure adjacent teeth periodontal status , Probing Depth , bleeding on probing. Volumetric measurements will include an intramural scanner from all the stages , we will use fixed landmarks (ex. adjacent teeth) to calibrate the STL measurements. Calculate the difference between pre-extraction socket and the post treatment with the alloplastic material. | Procedure or surgery | Extraction Socket Spontaneous Healing |
Primary outcome
Histologic Examination Histomorphometric Analysis
Time frame: 3 month after tooth extraction
Histologic measure, percentage of Vital Bone formation, Fibrous/connective tissue, and material remnant present in the sample.
7 secondary outcomes
Volumetric Changes Clinical
Time frame: at pre-extraction and at final crown insertion up to 1 year
Radiographic CBCT - Bone evaluation
Time frame: at pre-extraction and at final crown insertion up to 1 year
Primary and Secondary stability
Time frame: at implant placement and at dental crown insertion up to 1 year
Incidence of Implant Success rate
Time frame: at final treatment (crown insertion) up to 1 year
Implant probing depth
Time frame: At implant insertion and At final treatment (crown insertion) up to 1 year
Implant marginal bone loss.
Time frame: at implant placement and at final crown insertion (up to 1 year)
Incidence of Survival rate
Time frame: at dental crown placement (final treatment) up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2021.
Related trials for Bone Loss
Recruiting
Hemocoll, Avitene, or Bone Wax for Cancellous Bone Bleeding After Single-Ray Amputation
Hemostasis, Surgical Blood Loss
Enrolling by invitation
Investigation of the Effect of Horizontal Platelet Rich Fibrin Placed in Tooth Extraction Sockets on Bone Formation
Tooth Loss, Dental Implant Failed
RecruitingPhase 2/3
Lactoferrin Nanohydrogel for Soft And Hard Tissue Healing and Implant Stability in Immediate Implant Placement
Dental Implant, Wound Healing
Not yet recruiting
Exercise and Fall Prevention
Osteopenia, Osteoporosis
RecruitingPhase 1
Veverimer to Decrease Net Acid Excretion and Bone Resorption in Adults With Osteopenia
Osteopenia
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.
Joana Borges contact
Andre Chen, Phd principal investigator
International Advanced Dentistry
João Borges, Msc study director
International Advanced Dentistry
Elena Cervino, Msc study chair
International Advanced Dentistry
Questions about this trial
What is this clinical trial studying?
A study testing Socket Preservation - Bond Apatite synthetic bone substitute and Socket healing - No Filler in people with Bone Loss and Alveolar Bone Resorption, run by International Advanced Dentistry, Lisbon.
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 3 inclusion and 7 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 10 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
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 Andre Chen, Phd (00351919774343, ac@iadlisbon.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Histologic Examination Histomorphometric Analysis (time frame: 3 month after tooth extraction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Mar 2021.