EdentulousNCT01344577
Buccal Plate Augmentation With Different Hydroxyapatite Based Material
An observational study of Edentulous, run by University of Trieste at 1 site in Italy.
Trial summary
The purposes of this study are : (first) to evaluate comparatively the effectiveness of 2 HA-based biomaterials when used for socket preservation with Buccal Plate Augmentation technique; (second) to evaluate clinical outcomes of socket preservation procedures performed using the Buccal Plate Augmentation technique. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Edentulous
- How many people
- 96 participants
- Where
- 1 siteItaly
- Study dates
- May 2011to Dec 2013
- Phase
- Observational
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: primary care clinic
Who may be able to join
- The local inclusion criteria are the following:
- indication for a tooth extraction in the incisor, canine or premolar area of the upper arch (for any clinical reason);
- presence of at least one tooth adjacent to the one to be extracted;
- presence of at least 5 mm. of vertical bone support around the tooth to be extracted;
- presence of an intact buccal plate in the extraction socket;
- age of the patient >18 years;
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- patient will not wear any kind of removable prosthesis over the treatment area;
- patient will not undergo implant surgery in the treatment area up to 6 month from the extraction;
- patient willing and fully capable to comply with the study protocol;
- written informed consent given
Who cannot join
- acute myocardial infarction within the past 2 months,
- uncontrolled coagulation disorders,
- uncontrolled metabolic diseases (diabetes mellitus and bone pathologies),
- radiotherapy to the head/neck district within the past 24 months,
- present or past treatment with intravenous bisphosphonates,
- psychological or psychiatric problems, and alcohol or drugs abuse.
- Local exclusion criterion is the presence of uncontrolled or untreated periodontal disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Buccal Plate Augmentation Associated With Different Hydroxyapatite-based Biomaterials. A Multicenter Randomized Controlled Clinical Trial
The purposes of this study are : (first) to evaluate comparatively the effectiveness of 2 HA-based biomaterials when used for socket preservation with Buccal Plate Augmentation technique; (second) to evaluate clinical outcomes of socket preservation procedures performed using the Buccal Plate Augmentation technique.
Read the detailed description
Tooth loss results physiologically in a significant remodeling of the alveolar ridge. The bone resorption process begins immediately after extraction, leading to an average 40-60% decrease in the horizontal and vertical dimensions of the alveolar ridge, during the first 2 years (Amler 1969, Johnson 1969)1,2. The majority of post-extraction bone loss is more evident on the buccal aspect of the ridge (Pietrokovski \& Massler 1967)3 and occurs mainly within the first 3 months (Johnson 1969; Schropp et al. 2003)2,4. It is now known that crestal remodeling is strictly related to bundle bone resorption5 and that is more evident on the buccal plate where, especially in thin periodontal biotypes, can result in significant facial hard and soft tissue recessions. Bundle bone vascularization comes from periodontal ligament and it is interrupted by tooth extraction: for this reason bundle bone resorption and, consequent socket remodeling are impossible to prevent. Furthermore, modeling and remodeling of extraction sockets have a great variability in timing: a recent study (Trombelli et al. 2008) reports that bone organization and architecture is not completed 24 weeks after tooth extraction6.
In order to preserve ridge volumetry after extraction, many clinical techniques and various biomaterials have been suggested for grafting of post-extraction wounds7-12. Grafting of sockets provides stable clinical results but some studies demonstrate that, unless using a membrane, at histological examination most of the graft particles are encapsulated by fibrous tissue, especially in the coronal area 9,11. Recently, a study on an animal model (Araújo et al. 2009) reported that the presence of bone graft material in fresh extraction socket leads to a delayed healing response13.
On account of these observations, a novel surgical technique was presented in literature (Caiazzo et al. 2010)14, with the name of Buccal Plate Augmentation (BPA). After performing a gentle tooth extraction and verifying the integrity of the alveolar walls, BPA consists in placing a HA-based bone graft material over the intact buccal bone plate, underneath the soft tissues and the periosteum in a surgically created pouch with the aim to maintain or augment crestal volumetry and soft tissue aesthetics of the region. This approach allows for avoiding recession of the alveolar facial wall without interfering with the natural healing mechanism of the extraction socket, which is left undisturbed. To date, however, there is still no evidence regarding the most suitable biomaterial for maintaining predictably crestal volumetry and soft tissues contour overtime.
- Conditions
- Edentulous
- Keywords
- Buccal Plate Augmentation technique, socket preservation, porcine biomaterial
- Medical subject headings
- Mouth, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group1# | bone graft material used: Apatos Cortical® (porcine cortical bone 600-1000 µm) | |
| Group2# | bone graft material used: MP3® (porcine cortic-cancellous collagenated bone mix 600-1000 µm) | |
| Group3# | control group |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2011 (estimated)
- Study startMay 2011
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EdentulousStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Trieste
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ljubljana School of Medicine, Slovenia
- Responsible party
- Principal investigator, chiara navarra, University of Trieste
- Investigators
- Claudio Stacchi, DDS, Study director, University of TriesteChiara O Navarra, DDS,PHD, Principal investigator, University of TriesteRoberto Di Lenarda, DDS, PHD, Study chair, University of Trieste
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01344577
- Sponsor's protocol ID
- BPA-2011-units
- Status last verified
- Feb 2017
- First submitted
- 27 Apr 2011
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Buccal Plate Augmentation Associated With Different Hydroxyapatite-based Biomaterials. A Multicenter Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT01344577
- Acronym / sponsor ID
- BPA-2011-units
- Conditions
- Edentulous
- Keywords
- Buccal Plate Augmentation technique, socket preservation, porcine biomaterial
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- University of TriesteUniversity, hospital or other
- Collaborators
- University of Ljubljana School of Medicine, Slovenia
- Study start
- May 2011 (actual)
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 29 Apr 2011 (estimated)
- 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 purposes of this study are : (first) to evaluate comparatively the effectiveness of 2 HA-based biomaterials when used for socket preservation with Buccal Plate Augmentation technique; (second) to evaluate clinical outcomes of socket preservation procedures performed using the Buccal Plate Augmentation technique.
Detailed description
Tooth loss results physiologically in a significant remodeling of the alveolar ridge. The bone resorption process begins immediately after extraction, leading to an average 40-60% decrease in the horizontal and vertical dimensions of the alveolar ridge, during the first 2 years (Amler 1969, Johnson 1969)1,2. The majority of post-extraction bone loss is more evident on the buccal aspect of the ridge (Pietrokovski \& Massler 1967)3 and occurs mainly within the first 3 months (Johnson 1969; Schropp et al. 2003)2,4. It is now known that crestal remodeling is strictly related to bundle bone resorption5 and that is more evident on the buccal plate where, especially in thin periodontal biotypes, can result in significant facial hard and soft tissue recessions. Bundle bone vascularization comes from periodontal ligament and it is interrupted by tooth extraction: for this reason bundle bone resorption and, consequent socket remodeling are impossible to prevent. Furthermore, modeling and remodeling of extraction sockets have a great variability in timing: a recent study (Trombelli et al. 2008) reports that bone organization and architecture is not completed 24 weeks after tooth extraction6.
In order to preserve ridge volumetry after extraction, many clinical techniques and various biomaterials have been suggested for grafting of post-extraction wounds7-12. Grafting of sockets provides stable clinical results but some studies demonstrate that, unless using a membrane, at histological examination most of the graft particles are encapsulated by fibrous tissue, especially in the coronal area 9,11. Recently, a study on an animal model (Araújo et al. 2009) reported that the presence of bone graft material in fresh extraction socket leads to a delayed healing response13.
On account of these observations, a novel surgical technique was presented in literature (Caiazzo et al. 2010)14, with the name of Buccal Plate Augmentation (BPA). After performing a gentle tooth extraction and verifying the integrity of the alveolar walls, BPA consists in placing a HA-based bone graft material over the intact buccal bone plate, underneath the soft tissues and the periosteum in a surgically created pouch with the aim to maintain or augment crestal volumetry and soft tissue aesthetics of the region. This approach allows for avoiding recession of the alveolar facial wall without interfering with the natural healing mechanism of the extraction socket, which is left undisturbed. To date, however, there is still no evidence regarding the most suitable biomaterial for maintaining predictably crestal volumetry and soft tissues contour overtime.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group1# | – | –bone graft material used: Apatos Cortical® (porcine cortical bone 600-1000 µm) |
| Group2# | – | –bone graft material used: MP3® (porcine cortic-cancellous collagenated bone mix 600-1000 µm) |
| Group3# | – | –control group |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- primary care clinic
Key inclusion criteria (10 listed)
- The local inclusion criteria are the following:
Key exclusion criteria (7 listed)
- acute myocardial infarction within the past 2 months,
- uncontrolled coagulation disorders,
- uncontrolled metabolic diseases (diabetes mellitus and bone pathologies),
- radiotherapy to the head/neck district within the past 24 months,
- present or past treatment with intravenous bisphosphonates,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 23 Feb 2017.
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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, DDS study director
University of Trieste
Chiara O Navarra, DDS,PHD principal investigator
University of Trieste
Roberto Di Lenarda, DDS, PHD study chair
University of Trieste
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Edentulous, run by University of Trieste 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 10 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: finished, as of the sponsor's last update on 23 Feb 2017. 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.
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 23 Feb 2017.