Loss of Teeth Due to ExtractionPhase 4NCT01800149
Healing of Post-ext Sites Using Bovine Bone Mineral: a CBCT and Histologic RCCT
A Phase 4 study testing Ridge Augmentation in people with Loss of Teeth Due to Extraction and Edentulous Alveolar Ridge, run by Proed, Torino, Italy at 1 site in Italy.
Trial summary
Aim of the present investigation will be to evaluate the role of a bovine-bone mineral and a collagen membrane as ridge augmentation procedure following tooth extraction. 20 consecutive adult patients, requiring tooth extraction in the frontal area of the upper and lower arch maxilla (from second premolar to second… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Loss of Teeth Due to Extraction, Edentulous Alveolar Ridge
- What is being tested?
- Ridge Augmentation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2013to Dec 2014
- Phase
- Phase 4
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Healthy adult patients with one or more teeth to be extracted, from premolar to premolar
Who cannot join
- Heavy smokers (more than 10 cig per day)
- Current Pregnant patients
- History of malignancy
- History of radiotherapy or chemiotherapy in the past 5 years
- Long term steroidal or antibiotic therapy
Trial locations and contacts
1 site in 1 country.
Italy1 site
PROED, Institute for Professional Education in Dentistry
Torino, TO, 10129
About this study
Official title: Healing of Post-extraction Sites Using Bovine-bone Mineral: a CBCT and Histologic Randomized Controlled Clinical Study
Aim of the present investigation will be to evaluate the role of a bovine-bone mineral and a collagen membrane as ridge augmentation procedure following tooth extraction. 20 consecutive adult patients, requiring tooth extraction in the frontal area of the upper and lower arch maxilla (from second premolar to second premolar), will be enrolled into the study.
After tooth extraction, sockets will be randomized and divided into two groups: in Group A the socket will be grafted with Bio-Oss Collagen , in Group B the sockets will be grafted with BioOss granules (small granules). The graft will be covered with porcine collagen membrane (BioGide). Then, the flap will be sutured.
Read more
MEASUREMENTS:
The end of the study will be fixed at the 6 months evaluation after tooth extraction. Impression will be taken before tooth extraction and after 6 months in order to create cast models. On the cast models, using reference PVC (polyvinylchloride) guides, the horizontal dimension of the soft tissues will be measured. One measurement per tooth will be recorded, at T0 (before extraction) and T2 (after 6 months).
A 3D radiological image, using the CBCT technique, will be obtained at the end of the surgical stage T1 (extraction + bone graft) and after 6 months of healing. Superimposition will be performed in order to measure hard tissue remodelling.
After six months (T6), a a biopsy specimen will be also harvested for that augmented extractions sockets on which an implant installation has been previously planned.
Read the detailed description
Both animal and human studies have clearly demonstrated that the healing of post extraction sites usually results in pronounced alveolar ridge resorption, that mostly stabilized after 4 to 6 months. The marked tri-dimensional alterations of the ridge volume may jeopardize patients' aesthetics and create anatomical difficulties for further implant placement.
Aim of the present investigation will be to evaluate the role of a bovine-bone mineral and a collagen membrane as ridge augmentation procedure (intended as "increase of the ridge volume beyond the skeletal envelope existing at the time of extraction") following tooth extraction. Furthermore, the authors aim to evaluate as the collagen membrane acts when used for "open-healing".
20 consecutive adult patients, requiring tooth extraction in the frontal area of the upper and lower arch maxilla (from second premolar to second premolar), will be enrolled into the study.
After local anesthesia, a buccal full thickness flap will be elevated, and then the hopeless teeth will be gently extracted. All granulation tissue will be removed from the alveolus, that will be rinsed with saline. At this time the post-extraction sockets will be randomized and divided into two groups: in Group A the socket will be grafted with Bio-Oss Collagen , in Group B the sockets will be grafted with BioOss granules (small granules) using the Bio-Oss Pen device.
The graft will be covered with porcine collagen membrane (BioGide). Then, the flap will be sutured. The sutures (single sutures) will involve only the interdental gingival tissue, and no attempt will be done to reach a complete soft tissue closure of the sockets: in the alveolus area BioGide will be mostly left exposed, intended as "open healing" for second intention wound healing.
The patient swill assume antibiotics per 6 days (Amoxicillin + Clavulanate 1gr), and will rinse with Digluconate Chlorhexidine 0.20% per 14 days. At day 14 the sutures will be removed. If, at this moment, the gingiva over the graft will not be completely closed, the patient will use Digluconate Chlorhexidine 0.20% until the secondary closure will be completed.
MEASUREMENTS:
The end of the study will be fixed at the 6 months evaluation after tooth extraction (corresponding to the planned time for implant installation).
Impression will be taken before tooth extraction and after 6 months in order to create cast models. On the cast models, using reference PVC guides, the horizontal dimension of the soft tissues (measured perpendicular to the tangent of the dental arch at the midpoint of the extraction site as the distance between the most prominent points buccally and orally) will be measured. One measurement per tooth will be recorded, at T0 (before extraction) and T2 (after 6 months).
A 3D radiological image, using the CBCT technique, will be obtained at the end of the surgical stage T1 (extraction + bone graft) and after 6 months of healing. Using a diagnostic software, superimposition will be performed in order to measure hard tissue remodelling.
After six months (T6), a a biopsy specimen will be also harvested for that augmented extractions sockets on which an implant installation has been previously planned, with the purpose of an histologic and histomorphometric evaluation (measurement of new bone formation and measurement of remaining BioOss granules). The biopsy will be taken exactly in the area where dental implants will be placed.
- Being tested
- Ridge Augmentation
- Keywords
- Tooth extraction, Ridge Preservation, Ridge Augmentation, Guided Bone Regeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ridge AugmentationProcedure or surgery
After tooth extraction, the sockets will be filled with bovine bone mineral and covered with a porcine collagen membrane
| Study group | Role | What they receive |
|---|---|---|
| BBM+collagen | Active comparator | Ridge Augmentation After tooth extraction, edentulous sockets will be filled with BioOss Collagen and covered with Bio-Gide Receives: Procedure: Ridge Augmentation |
| BBM granules | Active comparator | Ridge Augmentation After tooth extraction, edentulous sockets will be filled with Bio-Oss Granules, 0-25-1 mm, and covered with Bio-Gide Receives: Procedure: Ridge Augmentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical horizontal width
On the cast models, using reference PVC stants, the horizontal dimension of the soft tissues (measured perpendicular to the tangent of the dental arch at the midpoint of the extraction site as the distance between the most prominent points buccally and orally) will be measured.
Measured: 6 months after tooth extraction
Secondary outcomes (1)
Radiological horizontal width
A 3D radiological image, using the CBCT technique, will be obtained at the end of the surgical stage T1 (extraction + bone graft) and after 6 months of healing. Using a diagnostic software, superimposition will be performed in order to measure hard tissue remodelling.
Measured: 6 months after tooth extraction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Loss of Teeth Due to ExtractionStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Proed, Torino, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniele Cardaropoli, DDS, Study director, Proed, Torino, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01800149
- Sponsor's protocol ID
- 01.2013.POST-EXT.PROED
- Status last verified
- Sep 2016
- First submitted
- 25 Feb 2013
- Last updated
- 2 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healing of Post-extraction Sites Using Bovine-bone Mineral: a CBCT and Histologic Randomized Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT01800149
- Acronym / sponsor ID
- 01.2013.POST-EXT.PROED
- Keywords
- Tooth extraction, Ridge Preservation, Ridge Augmentation, Guided Bone Regeneration
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Proed, Torino, ItalyUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 27 Feb 2013 (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.
Aim of the present investigation will be to evaluate the role of a bovine-bone mineral and a collagen membrane as ridge augmentation procedure following tooth extraction. 20 consecutive adult patients, requiring tooth extraction in the frontal area of the upper and lower arch maxilla (from second premolar to second premolar), will be enrolled into the study.
After tooth extraction, sockets will be randomized and divided into two groups: in Group A the socket will be grafted with Bio-Oss Collagen , in Group B the sockets will be grafted with BioOss granules (small granules). The graft will be covered with porcine collagen membrane (BioGide). Then, the flap will be sutured.
MEASUREMENTS:
The end of the study will be fixed at the 6 months evaluation after tooth extraction. Impression will be taken before tooth extraction and after 6 months in order to create cast models. On the cast models, using reference PVC (polyvinylchloride) guides, the horizontal dimension of the soft tissues will be measured. One measurement per tooth will be recorded, at T0 (before extraction) and T2 (after 6 months).
A 3D radiological image, using the CBCT technique, will be obtained at the end of the surgical stage T1 (extraction + bone graft) and after 6 months of healing. Superimposition will be performed in order to measure hard tissue remodelling.
After six months (T6), a a biopsy specimen will be also harvested for that augmented extractions sockets on which an implant installation has been previously planned.
Detailed description
Both animal and human studies have clearly demonstrated that the healing of post extraction sites usually results in pronounced alveolar ridge resorption, that mostly stabilized after 4 to 6 months. The marked tri-dimensional alterations of the ridge volume may jeopardize patients' aesthetics and create anatomical difficulties for further implant placement.
Aim of the present investigation will be to evaluate the role of a bovine-bone mineral and a collagen membrane as ridge augmentation procedure (intended as "increase of the ridge volume beyond the skeletal envelope existing at the time of extraction") following tooth extraction. Furthermore, the authors aim to evaluate as the collagen membrane acts when used for "open-healing".
20 consecutive adult patients, requiring tooth extraction in the frontal area of the upper and lower arch maxilla (from second premolar to second premolar), will be enrolled into the study.
After local anesthesia, a buccal full thickness flap will be elevated, and then the hopeless teeth will be gently extracted. All granulation tissue will be removed from the alveolus, that will be rinsed with saline. At this time the post-extraction sockets will be randomized and divided into two groups: in Group A the socket will be grafted with Bio-Oss Collagen , in Group B the sockets will be grafted with BioOss granules (small granules) using the Bio-Oss Pen device.
The graft will be covered with porcine collagen membrane (BioGide). Then, the flap will be sutured. The sutures (single sutures) will involve only the interdental gingival tissue, and no attempt will be done to reach a complete soft tissue closure of the sockets: in the alveolus area BioGide will be mostly left exposed, intended as "open healing" for second intention wound healing.
The patient swill assume antibiotics per 6 days (Amoxicillin + Clavulanate 1gr), and will rinse with Digluconate Chlorhexidine 0.20% per 14 days. At day 14 the sutures will be removed. If, at this moment, the gingiva over the graft will not be completely closed, the patient will use Digluconate Chlorhexidine 0.20% until the secondary closure will be completed.
MEASUREMENTS:
The end of the study will be fixed at the 6 months evaluation after tooth extraction (corresponding to the planned time for implant installation).
Impression will be taken before tooth extraction and after 6 months in order to create cast models. On the cast models, using reference PVC guides, the horizontal dimension of the soft tissues (measured perpendicular to the tangent of the dental arch at the midpoint of the extraction site as the distance between the most prominent points buccally and orally) will be measured. One measurement per tooth will be recorded, at T0 (before extraction) and T2 (after 6 months).
A 3D radiological image, using the CBCT technique, will be obtained at the end of the surgical stage T1 (extraction + bone graft) and after 6 months of healing. Using a diagnostic software, superimposition will be performed in order to measure hard tissue remodelling.
After six months (T6), a a biopsy specimen will be also harvested for that augmented extractions sockets on which an implant installation has been previously planned, with the purpose of an histologic and histomorphometric evaluation (measurement of new bone formation and measurement of remaining BioOss granules). The biopsy will be taken exactly in the area where dental implants will be placed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BBM+collagen | Active comparator | Procedure: Ridge AugmentationRidge Augmentation After tooth extraction, edentulous sockets will be filled with BioOss Collagen and covered with Bio-Gide |
| BBM granules | Active comparator | Procedure: Ridge AugmentationRidge Augmentation After tooth extraction, edentulous sockets will be filled with Bio-Oss Granules, 0-25-1 mm, and covered with Bio-Gide |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy adult patients with one or more teeth to be extracted, from premolar to premolar
Key exclusion criteria (5 listed)
- Heavy smokers (more than 10 cig per day)
- Current Pregnant patients
- History of malignancy
- History of radiotherapy or chemiotherapy in the past 5 years
- Long term steroidal or antibiotic therapy
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 |
|---|---|---|
| Ridge AugmentationAfter tooth extraction, the sockets will be filled with bovine bone mineral and covered with a porcine collagen membrane | Procedure or surgery | BBM granules, BBM+collagen |
Primary outcome
Clinical horizontal width
Time frame: 6 months after tooth extraction
On the cast models, using reference PVC stants, the horizontal dimension of the soft tissues (measured perpendicular to the tangent of the dental arch at the midpoint of the extraction site as the distance between the most prominent points buccally and orally) will be measured.
1 secondary outcome
Radiological horizontal width
Time frame: 6 months after tooth extraction
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 2 Sep 2016.
- Individual participant dataSharing planned: No
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.
Daniele Cardaropoli, DDS study director
Proed, Torino, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ridge Augmentation in people with Loss of Teeth Due to Extraction and Edentulous Alveolar Ridge, run by Proed, Torino, Italy 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 1 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 2 Sep 2016. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Clinical horizontal width (time frame: 6 months 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 2 Sep 2016.