A Phase 2 interventional study of Polycaprolactone Scaffold in Alveolar Ridge Resorption After Extraction, sponsored by National University Hospital, Singapore. Completed at 1 site in Singapore. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-30.
Sponsored by National University Hospital, Singapore · Phase 2, Interventional, and Treatment
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.
National University Hospital, Singapore is the lead sponsor of 444 studies on the registry; 96 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
To test the effectiveness of the PCL scaffold in maintaining the physical dimensions of the alveolar ridge after extraction.
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.
This study is completed, as verified in May 2008. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
National University Hospital, Singapore