Preservation of Alveolar Bone Height With PLGA BioscaffoldNCT00836797
Radiographic Assessment of Bone Regeneration in Alveolar Sockets With PLGA Scaffold
An observational study of Preservation of Alveolar Bone Height With PLGA Bioscaffold, run by Bio-Scaffold International Pte Ltd at 2 sites in 2 countries.
Trial summary
After extraction of a tooth, the bony socket heals naturally but due to the absent of the tooth and any presence of support in the socket, bone resorption occur both vertically and bucco lingually or bucco palataly. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Preservation of Alveolar Bone Height With PLGA Bioscaffold
- How many people
- 33 participants
- Where
- 2 sitesin 2 countries
- Study dates
- May 2007to Jul 2008
- 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 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Dental clinic patients undergoing teeth extraction
Who may be able to join
- Under going extraction of tooth including the surgical extraction.
- Healthy individual with no known medical problems.
- Not allergic to foreign body.
- Extractions which are not due to periodontal causes.
Who cannot join
- Bony disease.
- Bleeding disorder.
- Allergic to foreign body.
- Mentally retarded persons.
- Diabetic patient.
- Drug addict.
- Extraction due to periodontal disease.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
India1 site
Saveetha Dental College, Saveetha University
Chennai, Tamil Nadu, 600077
Singapore1 site
Dental Centre, National University Hospital,
Singapore, 119074
About this study
Official title: Phase I Radiographic Assessment of Bone Regeneration in Alveolar Sockets With PLGA Bioscaffold After Teeth Extraction
After extraction of a tooth, the bony socket heals naturally but due to the absent of the tooth and any presence of support in the socket, bone resorption occur both vertically and bucco lingually or bucco palataly. This bony resorption ultimately effects a lot of things like - the support for the adjacent teeth become weak, the shallow ridge makes it difficult for future prosthesis retention, and less bony support for any implant placement in the future which is the most popular and effective way of tooth replacement now a days. So now a days keeping the integrity and contour of the alveolar bony socket is very important for the patients future rehabilitation. The use of scaffold will help to maintain the integrity of the alveolar bony socket thus provides a vital support for the adjacent teeth, preserve the alveolar crest height, maintain the bony contour, helps to prevent bleeding, and most importantly it will help in bone regeneration which is the vital factor for future rehabilitation.
Read the detailed description
A case controlled study design is adopted. Patients who will be having extraction of any tooth including surgical extraction but not due to any periodontal reasons are selected. Consent of the patient will be taken for the procedure and all the effects and possibilities will be explained to the patients. Extraction will be done and scaffold material will be placed inside the socket. Sockets with the scaffold will be the variable studied and the sockets without scaffold placed inside the sockets will be the control group. An OPG x ray will be taken with the head position standardized by a positioning device. A second x-ray will be taken following the same technique after two months (for assessment of bone healing as is practiced normally) and a final x-ray will be taken after 3 months of the first x-ray (normally done in clinics for assessment of socket prior to implantation.
The OPG x ray is taken with the patient biting on a bite plate device fabricated with an embedded wire inside which is radiopague. If the distance from the wire line (the occlusal plane) to the alveolar bony height is 'a' and if the actual diameter of the metallic ball is 'b' and radiographic ball diameter is 'c' then the equation ( a×b)/c will give us the distance of the alveolar bony crest from the wire line. The measurements taken will determine if the distance of the alveolar crest from the wire line remained the same or has increased. If it remains the same, it will suggest that the scaffold material had maintained the socket and prevented alveolar bone resorption, but if the distance increases that will indicate vertical loss of alveolar bone and the extent measured can be compared with sockets without the support of an immediate post-extraction scaffold. This study will determine firstly whether the scaffold allows for bone regeneration in human alveolar sockets in the normal time and secondly whether it would help to preserve alveolar bone height as compared to cases without scaffold.
Consent of the selected patient will be taken for the procedure. Extraction will be done and scaffold material will be placed inside the socket. Socket with the scaffold will be our cases and the socket without scaffold will be the control group in multiple extraction cases. Radiographic assessment will be done to assess bone regeneration at the prescribed pre-extraction stage, at the 2 months bone healing stage and at the 3 months (from initial extraction) implant planning stage as in usual clinical practice . Assessment of the bony height is made with the prescribed formula from the radiographs taken and comparison will be made with the control cases. The following are the criteria for selecting the patients.
- Keywords
- Alveolar Bone Loss, Alveolar ridge, Alveolar Process
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 1 Case with scaffold | This group of patients will be having a placement of PLGA bioscaffold in the alveolar socket after teeth extraction | |
| 2 Control without scaffold | The Alveolar socket will be left to heal and no treatment/scaffold placement will be done |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preservation of Alveolar height
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2009 (estimated)
- Study startMay 2007
- Primary completionSep 2007
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preservation of Alveolar Bone Height With PLGA BioscaffoldStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bio-Scaffold International Pte Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National University Hospital, Singapore, Saveetha University
- Investigators
- Tai Weng Fan Victor, BDS FDSRCS, Principal investigator, National University of Singapore, Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00836797
- Sponsor's protocol ID
- BSI-001-VF
- Other IDs
- DSRB A/06/404
- Status last verified
- Feb 2009
- First submitted
- 3 Feb 2009
- Last updated
- 4 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Radiographic Assessment of Bone Regeneration in Alveolar Sockets With PLGA Bioscaffold After Teeth Extraction
- ClinicalTrials.gov ID
- NCT00836797
- Acronym / sponsor ID
- BSI-001-VF
- Keywords
- Alveolar Bone Loss, Alveolar ridge, Alveolar Process
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Bio-Scaffold International Pte LtdIndustry (pharma, biotech, devices)
- Collaborators
- National University Hospital, Singapore, Saveetha University
- Study start
- May 2007
- Primary completion
- Sep 2007 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 4 Feb 2009 (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.
After extraction of a tooth, the bony socket heals naturally but due to the absent of the tooth and any presence of support in the socket, bone resorption occur both vertically and bucco lingually or bucco palataly. This bony resorption ultimately effects a lot of things like - the support for the adjacent teeth become weak, the shallow ridge makes it difficult for future prosthesis retention, and less bony support for any implant placement in the future which is the most popular and effective way of tooth replacement now a days. So now a days keeping the integrity and contour of the alveolar bony socket is very important for the patients future rehabilitation. The use of scaffold will help to maintain the integrity of the alveolar bony socket thus provides a vital support for the adjacent teeth, preserve the alveolar crest height, maintain the bony contour, helps to prevent bleeding, and most importantly it will help in bone regeneration which is the vital factor for future rehabilitation.
Detailed description
A case controlled study design is adopted. Patients who will be having extraction of any tooth including surgical extraction but not due to any periodontal reasons are selected. Consent of the patient will be taken for the procedure and all the effects and possibilities will be explained to the patients. Extraction will be done and scaffold material will be placed inside the socket. Sockets with the scaffold will be the variable studied and the sockets without scaffold placed inside the sockets will be the control group. An OPG x ray will be taken with the head position standardized by a positioning device. A second x-ray will be taken following the same technique after two months (for assessment of bone healing as is practiced normally) and a final x-ray will be taken after 3 months of the first x-ray (normally done in clinics for assessment of socket prior to implantation.
The OPG x ray is taken with the patient biting on a bite plate device fabricated with an embedded wire inside which is radiopague. If the distance from the wire line (the occlusal plane) to the alveolar bony height is 'a' and if the actual diameter of the metallic ball is 'b' and radiographic ball diameter is 'c' then the equation ( a×b)/c will give us the distance of the alveolar bony crest from the wire line. The measurements taken will determine if the distance of the alveolar crest from the wire line remained the same or has increased. If it remains the same, it will suggest that the scaffold material had maintained the socket and prevented alveolar bone resorption, but if the distance increases that will indicate vertical loss of alveolar bone and the extent measured can be compared with sockets without the support of an immediate post-extraction scaffold. This study will determine firstly whether the scaffold allows for bone regeneration in human alveolar sockets in the normal time and secondly whether it would help to preserve alveolar bone height as compared to cases without scaffold.
Consent of the selected patient will be taken for the procedure. Extraction will be done and scaffold material will be placed inside the socket. Socket with the scaffold will be our cases and the socket without scaffold will be the control group in multiple extraction cases. Radiographic assessment will be done to assess bone regeneration at the prescribed pre-extraction stage, at the 2 months bone healing stage and at the 3 months (from initial extraction) implant planning stage as in usual clinical practice . Assessment of the bony height is made with the prescribed formula from the radiographs taken and comparison will be made with the control cases. The following are the criteria for selecting the patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 Case with scaffold | – | –This group of patients will be having a placement of PLGA bioscaffold in the alveolar socket after teeth extraction |
| 2 Control without scaffold | – | –The Alveolar socket will be left to heal and no treatment/scaffold placement will be done |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Dental clinic patients undergoing teeth extraction
Key inclusion criteria (4 listed)
- Under going extraction of tooth including the surgical extraction.
- Healthy individual with no known medical problems.
- Not allergic to foreign body.
- Extractions which are not due to periodontal causes.
Key exclusion criteria (7 listed)
- Bony disease.
- Bleeding disorder.
- Allergic to foreign body.
- Mentally retarded persons.
- Diabetic patient.
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
Preservation of Alveolar height
Time frame: 3 months
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 4 Feb 2009.
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.
Tai Weng Fan Victor, BDS FDSRCS principal investigator
National University of Singapore, Faculty of Dentistry
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preservation of Alveolar Bone Height With PLGA Bioscaffold, run by Bio-Scaffold International Pte Ltd at 2 sites in 2 countries.
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 4 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 4 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in India, 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.
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?
Preservation of Alveolar height (time frame: 3 months). 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 4 Feb 2009.