Alveolar Ridge Resorption After ExtractionPhase 2NCT00466414
Alveolar Ridge Preservation With Polycaprolactone Scaffold for Implant Site Development
A Phase 2 study testing Polycaprolactone Scaffold in people with Alveolar Ridge Resorption After Extraction, run by National University Hospital, Singapore at 1 site in Singapore.
Trial summary
It has been shown through research that alveolar ridges (Part of jaw bone holding teeth) tend to lose width and height after extraction of teeth. Lost in height and width of the ridge can cause problems in the restoration of missing teeth with bridges and implants. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alveolar Ridge Resorption After Extraction
- What is being tested?
- Polycaprolactone Scaffold
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteSingapore
- Study dates
- 12 Mar 2007to 30 Jun 2010
- Phase
- Phase 2
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Having 1 or more unsalvageable non-molar teeth indicated for extraction due to periodontal disease, endodontic failures, crown/root fractures, extensive caries or trauma
- Have the indications for dental implant placement
- Given alternative options and chose replacement by endosseous implants following extractions
- If more than 1 tooth is to be replaced with implants, they should not be adjacent to each other
- Position of unsalvageable tooth is close to final implant position
- Good to fair oral hygiene (No probing depths <5mm and Gingivitis score of <20%)
Who cannot join
- Immunocompromised state
- Prior radiotherapy to extraction site
- Chemotherapy in the past 12 months
- Blood disorders
- Uncontrolled diabetes
- Uncontrolled hypertension
Show all 16Show fewer
- Long term steroid or anti-inflammatory therapy
- Require antibiotic prophylaxis before dental treatment
- Other uncontrolled systemic disease
- Drug or alcohol abusers
- Active infection in extraction site
- Heavy smoker (> 10 sticks a day)
- Pregnancy/Lactation
- Known allergies to plastics or other polymer
- Unwillingness to undergo basic dental treatment like caries-control and periodontal therapy
- Failure to sign informed consent form
Trial locations and contacts
1 site in 1 country.
About this study
It has been shown through research that alveolar ridges (Part of jaw bone holding teeth) tend to lose width and height after extraction of teeth. Lost in height and width of the ridge can cause problems in the restoration of missing teeth with bridges and implants. Hence, this study is proposed to assess the use of polycaprolactone (PCL) scaffolds for alveolar ridge preservation following extraction of teeth in humans.
20 patients will be divided into 2 groups. In one group, patients will have a PCL scaffold placed into the socket after extraction. In other group, no scaffold will be placed. After a healing period of 6 months, changes in width and height from baseline is measured for both groups. A bone biopsy is also taken at this time from both groups. Hardness of bone, histologic (microscopic) features of cells, percentage of living bone, radiographic density of alveolar ridge and mechanical properties of the bone biopsy are then assessed.
Read more
This study will attempt to show that a resorbable (can be removed by body) material like a PCL scaffold can be used to maintain physical dimensions of the alveolar ridge after extraction and will not interfere with osseointegration (fusion with bone). It will avoid the necessity for additional corrective surgeries for patients when alveolar ridges presented with inadequate width and height for placement of aesthetically pleasing and functionally sound restorations. This would improve chances of success for the patient.
If the study successfully shows that the PCL scaffold can be accepted by the body with good bone growth, uses for the PCL scaffold can be extended to other areas of clinical medicine and dentistry.
The PCL scaffold to be used in this study is designed and developed by a local company (Osteopore International Pte Ltd). With the success of this product, Singapore's standing as a biomedical hub will be further enhanced.
- Being tested
- Polycaprolactone Scaffold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polycaprolactone ScaffoldDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
To test the effectiveness of the PCL scaffold in maintaining the physical dimensions of the alveolar ridge after extraction.
Secondary outcomes (2)
To assess the percentage of living bone that is formed during healing with presence of PCL scaffold.
To assess the possibility of using density of CT scan to determine the percentage of living bone in the site for implant placement.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2007 (estimated)
- Study start12 Mar 2007
- Primary completion30 Jun 2010
- Study completion30 Jun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Ridge Resorption After ExtractionStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ang Chee Wan, BDS, Principal investigator, National University of SingaporeLim Thiam Chye, FRCS, Principal investigator, National University Hospital, SingaporeLim Lum Peng, MSc, Principal investigator, National University of SingaporeChung Kong Mun, MS, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00466414
- Sponsor's protocol ID
- R-222-000-024-112
- Status last verified
- May 2008
- First submitted
- 25 Apr 2007
- Last updated
- 30 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alveolar Ridge Preservation With Polycaprolactone Scaffold for Implant Site Development
- ClinicalTrials.gov ID
- NCT00466414
- Acronym / sponsor ID
- R-222-000-024-112
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- 12 Mar 2007 (actual)
- Primary completion
- 30 Jun 2010 (actual)
- Study completion
- 30 Jun 2010 (actual)
- First posted
- 27 Apr 2007 (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.
It has been shown through research that alveolar ridges (Part of jaw bone holding teeth) tend to lose width and height after extraction of teeth. Lost in height and width of the ridge can cause problems in the restoration of missing teeth with bridges and implants. Hence, this study is proposed to assess the use of polycaprolactone (PCL) scaffolds for alveolar ridge preservation following extraction of teeth in humans.
20 patients will be divided into 2 groups. In one group, patients will have a PCL scaffold placed into the socket after extraction. In other group, no scaffold will be placed. After a healing period of 6 months, changes in width and height from baseline is measured for both groups. A bone biopsy is also taken at this time from both groups. Hardness of bone, histologic (microscopic) features of cells, percentage of living bone, radiographic density of alveolar ridge and mechanical properties of the bone biopsy are then assessed.
This study will attempt to show that a resorbable (can be removed by body) material like a PCL scaffold can be used to maintain physical dimensions of the alveolar ridge after extraction and will not interfere with osseointegration (fusion with bone). It will avoid the necessity for additional corrective surgeries for patients when alveolar ridges presented with inadequate width and height for placement of aesthetically pleasing and functionally sound restorations. This would improve chances of success for the patient.
If the study successfully shows that the PCL scaffold can be accepted by the body with good bone growth, uses for the PCL scaffold can be extended to other areas of clinical medicine and dentistry.
The PCL scaffold to be used in this study is designed and developed by a local company (Osteopore International Pte Ltd). With the success of this product, Singapore's standing as a biomedical hub will be further enhanced.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Having 1 or more unsalvageable non-molar teeth indicated for extraction due to periodontal disease, endodontic failures, crown/root fractures, extensive caries or trauma
- Have the indications for dental implant placement
- Given alternative options and chose replacement by endosseous implants following extractions
- If more than 1 tooth is to be replaced with implants, they should not be adjacent to each other
- Position of unsalvageable tooth is close to final implant position
Key exclusion criteria (16 listed)
- Immunocompromised state
- Prior radiotherapy to extraction site
- Chemotherapy in the past 12 months
- Blood disorders
- Uncontrolled diabetes
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 |
|---|---|---|
| Polycaprolactone Scaffold | Device | – |
Primary outcome
To test the effectiveness of the PCL scaffold in maintaining the physical dimensions of the alveolar ridge after extraction.
2 secondary outcomes
To assess the percentage of living bone that is formed during healing with presence of PCL scaffold.
To assess the possibility of using density of CT scan to determine the percentage of living bone in the site for implant placement.
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 30 Mar 2020.
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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.
Ang Chee Wan, BDS principal investigator
National University of Singapore
Lim Thiam Chye, FRCS principal investigator
National University Hospital, Singapore
Lim Lum Peng, MSc principal investigator
National University of Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Polycaprolactone Scaffold in people with Alveolar Ridge Resorption After Extraction, run by National University Hospital, Singapore at 1 site in Singapore.
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 6 inclusion and 16 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 30 Mar 2020. 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 Singapore. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
To test the effectiveness of the PCL scaffold in maintaining the physical dimensions of the alveolar ridge after 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 30 Mar 2020.