Alveolar Bone LossSO-GHINCT03357705
Effectiveness in Limiting the Need to Elevate the Maxillary Sinus
A study testing alveolar ridge preservation with synthetic bone and alveolar ridge preservation with bovine collagen in people with Alveolar Bone Loss, run by International Piezosurgery Academy at 1 site in Italy.
Trial summary
The aim of the present study is to evaluate the effectiveness of different alveolar preservation procedures performed at the time of extraction of the first or second upper molar in avoiding a maxillary sinus elevation or at least limiting the size, to allow the insertion of dental implants. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alveolar Bone Loss
- What is being tested?
- alveolar ridge preservation with synthetic bone and alveolar ridge preservation with bovine collagen
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 31 Oct 2017to 28 Dec 2018
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- indication for extraction of the first or second upper molar, based on a thorough diagnosis and treatment plan;
- "three-rooted" anatomy of the first or second upper molar to be extracted so that it can have an inter-radicular septum that allows a precise measurement of the height of the bone ridge from the septum itself and from the walls of the 3 alveoli to the floor of the maxillary sinus;
- Extraction of intercalate molar or last arch element;
Who cannot join
- Anatomy of the molar with unique root or fused roots
- contextual extraction of the molar and one or more contiguous elements
- apical lesions with a diameter of> 3 mm or cystic lesions with respect to the element to be extracted
- root fracture which has produced resorption or bone fenestration
- 1) acute myocardial infarction in the last six months; 2) uncontrolled clotting disorders; 3) uncontrolled diabetes (HBA1c> 7.5%); 4) radiotherapy in the head / neck district for the last 24 months; 5) immunocompromise (eg HIV infection or chemotherapy over the last 3 years); 6) treatment in progress or with bisphosphonates via e.v .; 7) autoimmune diseases in chronic therapy with methotrexate or other immunosuppressive drugs; 8) allergy to bovine collagen; 9) psychological or psychiatric problems; 10) abuse of alcohol or drug use; 11) uncontrolled periodontal disease;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Different Alveolar Preservation Procedures in the Upper Molar Zone in Limiting the Need to Elevate the Maxillary Sinus to Allow the Placement of Dental Implants: a Prospective Cohort Multicentre Clinical Study.
The aim of the present study is to evaluate the effectiveness of different alveolar preservation procedures performed at the time of extraction of the first or second upper molar in avoiding a maxillary sinus elevation or at least limiting the size, to allow the insertion of dental implants. The residual bone height will be radiographically evaluated on the sinus sinus floor at the time of extraction and after 6 months by comparing the cases where alveolar preservation is performed using a nanocrystalline synthetic hydroxyapatite graft (group A) with cases where the procedure of alveolar preservation is performed using bovine collagen sponge (group B).
Read the detailed description
Bone resorption and contraction of bone volumes are physiologically occurring after the extraction of any dental element. This reabsorption of the alveolar process results in a reduction in the size of the alveolar crest both in width and in height. Numerous studies have attempted to quantify the size and timing of contraction of bone volumes after a dental flotation. The data reported in the literature show an average horizontal reduction of about 2.5 mm, which appears more marked by the vestibular side than the palatal one. The vertical contraction of the crest is estimated at 25-30%, with bone loss of 1-2 mm and a soft contraction of soft tissues of about 2 mm. In the area of the first and second upper molars, however, the total contraction of the alveoli is greater because the residual crest at the insertion of the implant would have undergone a double reduction, namely from the coronal side with the mechanisms just indicated, but also from the apex , for maxillary sinus pneumonia due to the absence of dental element6. For this reason, insertion of an implant in this area may be difficult due to an inadequate height of the remaining bone, which necessitates a bone regeneration procedure, ie a maxillary sinus elevation. This procedure allows you to regain the abdominal apex lost and the insertion of adequate lengths. In the presence of satisfactory residual bone height, maxillary sinus breast can be performed crestally, while in more markedly atrophic cases, especially in the presence of anatomically wide breasts, a side-by-side approach is preferable.
Various grafting materials have been used to perform alveolar retention with the aim of limiting the contraction of bone volumes and improving bone formation: autologous bone, homologous bone and bone substitutes of heterologous origin or alloplastic.
The use of autologous bone in alveolar preservation was soon abandoned for bone marrow morbidity, especially when deciding to use a donor site other than the extraction area. The homologous bone, although showing excellent results, is still to date problematic use in Italy. The heterologous grafts have been widely used for alveolar preservation; however, especially if bovine bone is used, significant percentages of graft (up to 25%) are histologically observable at 9 months from graft.
For these reasons, in this study it was decided to use as a graft in Group A a synthetic material (nanocrystalline synthetic hydroxyapatite) and in group B a collagen of bovine origin.
Bovine collagen, while having reduced dimensional stability over time, has the advantage of contributing to stabilizing the clot, an essential basis for bone healing, and is completely replaced by newly formed tissue in a short time. Synthetic hydroxyapatite, used as a biomaterial, has shown ability to stimulate osteoconduction and is slowly but completely replaced over time by newly formed bone, thus providing a great capacity for maintaining volumes.
Moreover, nanostructured porous hydroxyapatite appear to favor adhesion of bone matrix proteins and promote differentiation of osteogenetic cells. Although the nanocrystalline hydroxyapatite in a silica gel matrix has already been successfully tested as a clotting material in the maxillary sinus, the behavior of pure sintered nano-hydroxyapatite granules has not yet been evaluated in terms of osteoconductive potential and dimensional stability in time at post-mining sites.
- Conditions
- Alveolar Bone Loss
- Being tested
- alveolar ridge preservation with synthetic bone, alveolar ridge preservation with bovine collagen
- Keywords
- alveolar ridge preservation
- Medical subject headings
- Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alveolar ridge preservation with synthetic boneProcedure or surgery
Also called Ghimas
after tooth extraction
alveolar ridge preservation with bovine collagenProcedure or surgery
Also called Septodont
after tooth extraction
| Study group | Role | What they receive |
|---|---|---|
| synthetic | Experimental | alveolar ridge preservation with synthetic bone Receives: Procedure: alveolar ridge preservation with synthetic bone |
| collagen | Active comparator | alveolar ridge preservation with bovine collagen Receives: Procedure: alveolar ridge preservation with bovine collagen |
What is being measured
The primary outcome is the main question the study is designed to answer.
radiographic distance between crestal bone and implant platform
necessity of sinus floor regeneration
Measured: 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2017
- Study start31 Oct 2017
- Primary completion31 Oct 2018
- Study completion28 Dec 2018
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 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
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Piezosurgery Academy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mr. Claudio Stacchi, DDS, MSc, International Piezosurgery Academy
- Investigators
- Claudio Stacchi, Dr, Study director, Piezosurgery Academy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03357705
- Sponsor's protocol ID
- SO-GHI
- Acronym
- SO-GHI
- Status last verified
- Mar 2019
- First submitted
- 24 Nov 2017
- Last updated
- 20 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Carlsson GE, Bergman B, Hedegard B. Changes in contour of the maxillary alveolar process under immediate dentures. A longitudinal clinical and x-ray cephalometric study covering 5 years. Acta Odontol Scand. 1967 Jun;25(1):45-75. doi: 10.3109/00016356709072522. No abstract available.
PubMed 5233859Sharan A, Madjar D. Maxillary sinus pneumatization following extractions: a radiographic study. Int J Oral Maxillofac Implants. 2008 Jan-Feb;23(1):48-56.
PubMed 18416412
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Different Alveolar Preservation Procedures in the Upper Molar Zone in Limiting the Need to Elevate the Maxillary Sinus to Allow the Placement of Dental Implants: a Prospective Cohort Multicentre Clinical Study.
- ClinicalTrials.gov ID
- NCT03357705
- Acronym / sponsor ID
- SO-GHI / SO-GHI
- Conditions
- Alveolar Bone Loss
- Keywords
- alveolar ridge preservation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- International Piezosurgery AcademyUniversity, hospital or other
- Study start
- 31 Oct 2017 (actual)
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 28 Dec 2018 (actual)
- First posted
- 30 Nov 2017 (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 aim of the present study is to evaluate the effectiveness of different alveolar preservation procedures performed at the time of extraction of the first or second upper molar in avoiding a maxillary sinus elevation or at least limiting the size, to allow the insertion of dental implants. The residual bone height will be radiographically evaluated on the sinus sinus floor at the time of extraction and after 6 months by comparing the cases where alveolar preservation is performed using a nanocrystalline synthetic hydroxyapatite graft (group A) with cases where the procedure of alveolar preservation is performed using bovine collagen sponge (group B).
Detailed description
Bone resorption and contraction of bone volumes are physiologically occurring after the extraction of any dental element. This reabsorption of the alveolar process results in a reduction in the size of the alveolar crest both in width and in height. Numerous studies have attempted to quantify the size and timing of contraction of bone volumes after a dental flotation. The data reported in the literature show an average horizontal reduction of about 2.5 mm, which appears more marked by the vestibular side than the palatal one. The vertical contraction of the crest is estimated at 25-30%, with bone loss of 1-2 mm and a soft contraction of soft tissues of about 2 mm. In the area of the first and second upper molars, however, the total contraction of the alveoli is greater because the residual crest at the insertion of the implant would have undergone a double reduction, namely from the coronal side with the mechanisms just indicated, but also from the apex , for maxillary sinus pneumonia due to the absence of dental element6. For this reason, insertion of an implant in this area may be difficult due to an inadequate height of the remaining bone, which necessitates a bone regeneration procedure, ie a maxillary sinus elevation. This procedure allows you to regain the abdominal apex lost and the insertion of adequate lengths. In the presence of satisfactory residual bone height, maxillary sinus breast can be performed crestally, while in more markedly atrophic cases, especially in the presence of anatomically wide breasts, a side-by-side approach is preferable.
Various grafting materials have been used to perform alveolar retention with the aim of limiting the contraction of bone volumes and improving bone formation: autologous bone, homologous bone and bone substitutes of heterologous origin or alloplastic.
The use of autologous bone in alveolar preservation was soon abandoned for bone marrow morbidity, especially when deciding to use a donor site other than the extraction area. The homologous bone, although showing excellent results, is still to date problematic use in Italy. The heterologous grafts have been widely used for alveolar preservation; however, especially if bovine bone is used, significant percentages of graft (up to 25%) are histologically observable at 9 months from graft.
For these reasons, in this study it was decided to use as a graft in Group A a synthetic material (nanocrystalline synthetic hydroxyapatite) and in group B a collagen of bovine origin.
Bovine collagen, while having reduced dimensional stability over time, has the advantage of contributing to stabilizing the clot, an essential basis for bone healing, and is completely replaced by newly formed tissue in a short time. Synthetic hydroxyapatite, used as a biomaterial, has shown ability to stimulate osteoconduction and is slowly but completely replaced over time by newly formed bone, thus providing a great capacity for maintaining volumes.
Moreover, nanostructured porous hydroxyapatite appear to favor adhesion of bone matrix proteins and promote differentiation of osteogenetic cells. Although the nanocrystalline hydroxyapatite in a silica gel matrix has already been successfully tested as a clotting material in the maxillary sinus, the behavior of pure sintered nano-hydroxyapatite granules has not yet been evaluated in terms of osteoconductive potential and dimensional stability in time at post-mining sites.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| synthetic | Experimental | Procedure: alveolar ridge preservation with synthetic bonealveolar ridge preservation with synthetic bone |
| collagen | Active comparator | Procedure: alveolar ridge preservation with bovine collagenalveolar ridge preservation with bovine collagen |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- indication for extraction of the first or second upper molar, based on a thorough diagnosis and treatment plan;
- "three-rooted" anatomy of the first or second upper molar to be extracted so that it can have an inter-radicular septum that allows a precise measurement of the height of the bone ridge from the septum itself and from the walls of the 3 alveoli to the floor of the maxillary sinus;
- Extraction of intercalate molar or last arch element;
Key exclusion criteria (5 listed)
- Anatomy of the molar with unique root or fused roots
- contextual extraction of the molar and one or more contiguous elements
- apical lesions with a diameter of> 3 mm or cystic lesions with respect to the element to be extracted
- root fracture which has produced resorption or bone fenestration
- 1) acute myocardial infarction in the last six months; 2) uncontrolled clotting disorders; 3) uncontrolled diabetes (HBA1c> 7.5%); 4) radiotherapy in the head / neck district for the last 24 months; 5) immunocompromise (eg HIV infection or chemotherapy over the last 3 years); 6) treatment in progress or with bisphosphonates via e.v .; 7) autoimmune diseases in chronic therapy with methotrexate or other immunosuppressive drugs; 8) allergy to bovine collagen; 9) psychological or psychiatric problems; 10) abuse of alcohol or drug use; 11) uncontrolled periodontal disease;
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 |
|---|---|---|
| alveolar ridge preservation with synthetic boneAlso: Ghimasafter tooth extraction | Procedure or surgery | synthetic |
| alveolar ridge preservation with bovine collagenAlso: Septodontafter tooth extraction | Procedure or surgery | collagen |
Primary outcome
radiographic distance between crestal bone and implant platform
Time frame: 6 months after surgery
necessity of sinus floor regeneration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2019.
- Background: PubMed 5233859Carlsson GE, Bergman B, Hedegard B. Changes in contour of the maxillary alveolar process under immediate dentures. A longitudinal clinical and x-ray cephalometric study covering 5 years. Acta Odontol Scand. 1967 Jun;25(1):45-75. doi: 10.3109/00016356709072522. No abstract available.
- Background: PubMed 18416412Sharan A, Madjar D. Maxillary sinus pneumatization following extractions: a radiographic study. Int J Oral Maxillofac Implants. 2008 Jan-Feb;23(1):48-56.
- Individual participant dataSharing planned: No
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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.
Claudio Stacchi, Dr study director
Piezosurgery Academy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing alveolar ridge preservation with synthetic bone and alveolar ridge preservation with bovine collagen in people with Alveolar Bone Loss, run by International Piezosurgery Academy at 1 site in Italy.
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 5 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: finished, as of the sponsor's last update on 20 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
radiographic distance between crestal bone and implant platform (time frame: 6 months after surgery). 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 NCT03357705, 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 20 Mar 2019.